ANZCTR - Registration

Technical difficulties have been reported by some users of the search function and is being investigated by technical staff. Thank you for your patience and apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

Trial registered on ANZCTR

Registration number

ACTRN12617001566325

Ethics application status

Approved

Date submitted

8/11/2017

Date registered

21/11/2017

Date last updated

3/12/2020

Date data sharing statement initially provided

18/07/2019

Type of registration

Retrospectively registered

Titles & IDs

Public title

Circulating Tumour DNA Analysis Informing Adjuvant Chemotherapy in Stage III Colon Cancer: A Multicentre Phase II/III Randomised Controlled Study (DYNAMIC-III)

Scientific title

Circulating Tumour DNA Analysis Informing Adjuvant Chemotherapy in Stage III Colon Cancer: A Multicentre Phase II/III Randomised Controlled Study (DYNAMIC-III)

Secondary ID [1]

ctDNA-08

Universal Trial Number (UTN)

U1111-1204-7664

Trial acronym

DYNAMIC-III

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Colorectal Cancer

Condition category

Condition code

Cancer

Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

This design incorporates two separate clinical objectives; (i) non-inferiority and (ii) benefit.
This prospective multi-centre, phase II/III randomised study aims to enrol a total of 1000 stage III colon cancer patients. Patients will be randomised 1:1 to be treated according to post-op ctDNA results (Arm B: ctDNA-informed), or per standard of care (Arm A: SOC). Enrolment will be stratified by participating centre and clinical risk groups (low risk = T1-3N1; high risk = T4 and/or N2).

Patients should be screened up to 6 weeks after surgery and tumour samples will be made available in 5 working days from consent for mutation analysis. Patients will have a blood draw during week 5-6 post-op for ctDNA analysis (ctDNA-1: post-op day 32 to day 42). Clinicians are to nominate their standard of care adjuvant chemotherapy regimen (no chemotherapy, single agent fluoropyrimidine or combination fluropyrimidine plus oxaliplatin) at the time of enrolment prior to randomisation. Randomisation will occur after the post-op ctDNA blood draw and receipt of sufficient tumour tissue. Additional blood collection time-points will depend on the schedule of adjuvant chemotherapy. Formalin-fixed paraffin embedded tumour tissue and the study bloods sample will undergo ctDNA analysis at Johns Hopkins University.

In the ctDNA-informed arm (Arm B), the post-op ctDNA result will be made available to the treating clinician approx 4-5 weeks after receipt of tumour tissue. Adjuvant chemotherapy will commence after the ctDNA result becomes available or, where the treating clinician wishes to commence adjuvant treatment before the result is available, an individual patient may commence on standard of care treatment no earlier than 6 weeks post-op, and then switch to the ctDNA informed strategy as per the protocol. Patients who are "ctDNA negative" will be managed with a de-escalation adjuvant treatment strategy and those who are "ctDNA-positive" will be managed with an escalation adjuvant treatment strategy. In the standard of care arm, patients and their clinicians will be blinded to the ctDNA results and will receive adjuvant chemotherapy as per standard of care.

Patients in Arm B receiving 3 or 6 months of adjuvant chemotherapy will have blood collection for ctDNA analysis prior to and during treatment (ctDNA-2, ctDNA-2A +/- ctDNA-2B) and at the end of treatment (ctDNA-3). These results will not be routinely made available to the patients or clinicians.

For patients where standard treatment of oxaliplatin based treatment is escalated to FOLFOXIRI, this will be given for at least 6 cycles.

TREATMENT REGIMENS:

Unless otherwise specified, duration of chemotherapy (3 or 6 months) and dose modifications on treatment are at clinician's discretion.

Recommended single agent fluoropyrimidine based chemotherapy regimens include:
1. 2 weekly De Gramont (modified)
a) Leucovorin 50mg IV (intravenous)
b) Fluorouracil 400mg/m2 IV (intravenous)
c) Fluorouracil 2400mg/m2 CIV (continuous intravenous) pump over 46 hours

2. Weekly modified QUASAR
a) Leucovorin 50mg IV (intravenous)
b) Fluorouracil 375-450mg/m2 IV (intravenous)(dose as per institutional standard of care)

3. Weekly modified Roswell Park (weekly for 6 weeks followed by 2 week break)
a) Leucovorin 50mg IV (intravenous)
b) Fluorouracil 500mg/m2 IV (intravenous)

4. Capecitabine orally days 1 to 14, every 21 days (dose as per institutional standard of care)

Recommended combination oxaliplatin-based chemotherapy regimens include 12 or 24 weeks of:

1. 2 weekly FOLFOX6 (modified)
a) Oxaliplatin 85mg/m2 IV (intravenous)
b) Leucovorin 50mg IV (intravenous)
c) Fluorouracil 400mg/m2 IV (intravenous)
d) Fluorouracil 2400mg/m2 CIV (continuous intravenous) pump over 46 hours

2. 3 weekly CAPOX
a) Oxaliplatin 130mg/m2
b) Capecitabine 1000mg/m2 twice a day orally days 1 to 14, every 21 days

Recommended triplet chemotherapy regimen includes 12 to 24 weeks of:
1. 2 weekly FOLFOXIRI
a) Irinotecan 165mg/m2 IV (intravenous)
b) Oxaliplatin 85 mg/m2IV (intravenous)
c) Leucovorin 50mg IV (intravenous)
d) Fluorouracil 3200mg/m2 CIV (continuous intravenous) pump over 46 hours

Standard of Care Arm (Arm A)

Clinician's choice of:
- no adjuvant chemotherapy
- fluoropyrimidine chemotherapy
-combination fluoropyrimidine plus oxaliplatin chemotherapy

ctDNA-Informed Arm (Arm B)

De-escalation or escalation chemotherapy regimen will be based on clinician's chosen standard of care chemotherapy regimen prior to randomisation

Standard of care choice - no chemo
-ctDNA Negative: No adjuvant chemotherapy
-ctDNA Positive: 3 months of fluoropyrimidine alone

Standard of care choice - 6 months of fluoropyrimidine alone chemotherapy
-ctDNA Negative: No adjuvant chemotherapy or 3 months of fluoropyrimidine chemotherapy
-ctDNA Positive: 6 months of combination fluoropyrimidine plus oxaliplatin chemotherapy

Standard of care choice - 3 months of combination fluoropyrimidine plus oxaliplatin chemotherapy
-ctDNA Negative: fluoropyrimidine chemotherapy
-ctDNA Positive: 6 months of combination fluoropyrimidine plus oxaliplatin or triplet chemotherapy (FOLFOXIRI) for 6 cycles, followed by further treatment at clinician discretion.

Standard of care choice - 6 months of combination fluoropyrimidine plus oxaliplatin chemotherapy
-ctDNA Negative: fluoropyrimidine alone or 3 months of combination fluoropyrimidine plus oxaliplatin
-ctDNA Positive: triplet chemotherapy (FOLFOXIRI) for 6 cycles, followed by further treatment at clinician discretion.

Details of adjuvant chemotherapy received, including start and stop dates, dose received, dose reduction, reason for dose reduction/interruption and reason for stopping treatment will be recorded.

Interim Analysis for Futility:

Prior to completing the phase II component, futility of the observed de-escalation rate will be evaluated. After 38 patients in the ctDNA negative cohort have been enrolled and managed according to the ctDNA result, if fewer than 26 of these patients have been de-escalated then consideration will be given to either modifying the protocol or not continuing to the 100 patients in this group.

Intervention code [1]

Early detection / Screening

Intervention code [2]

Treatment: Drugs

Comparator / control treatment

Standard of Care Arm (Arm A)

Clinician's choice of:

1) No adjuvant chemotherapy
2) Fluoropyrimidine chemotherapy
3) Combination fluoropyrimidine plus oxaliplatin chemotherapy

Subjects and clinicians in SOC arms will be blinded to their ctDNA results and will receive adjuvant chemotherapy as per standard of care.

Control group

Active

Outcomes

Primary outcome [1]

Primary Objective - To evaluate the impact of de-escalation/escalation treatment strategies as informed by post-op ctDNA analysis. The ctDNA positive and negative cohorts will be evaluated separately:
a. For ctDNA negative patients, the trial will evaluate that a de-escalation treatment strategy is non-inferior to standard of care treatment as measured by the rate of 3-year recurrence-free survival.
b. For the ctDNA positive patients, the trial will investigate if an escalation treatment strategy is superior to standard of care treatment as measured by the 24 month recurrence-free survival

Timepoint [1]

Patients from all arms will be followed up every 3 months for the first 2 years and then every 6 months for the next 3 years post surgery for recurrence. Recurrence-free survival at 3 years post randomisation is measured by the time interval between randomisation and date of first recurrence. Recurrence is defined as evidence of disease either locally or distantly. Clinical assessment, radiological work-up and histological confirmation of recurrent disease will prove the presence of recurrent disease .

Secondary outcome [1]

To demonstrate that a ctDNA-informed adjuvant therapy approach does not compromise recurrence free survival compared to standard of care adjuvant therapy in patients with NEGATIVE post-op ctDNA.

Timepoint [1]

Patients from all arms will be followed up every 3 months for the first 2 years and then every 6 months for the next 3 years post surgery for survival. Overall survival is measured by the time interval between randomisation and date of death from all causes.

Secondary outcome [2]

To correlate end of treatment ctDNA results with recurrence-free and overall survival

Timepoint [2]

Patients who receive treatment on the ctDNA informed arm will have "on treatment" and "end of treatment" blood tests to measure their ctDNA levels at 2 to 3 defined timepoints during treatment. The timing of these tests is dependent on the treatment regimen and duration of chemotherapy. Patients will be followed up every 3 months for the first 2 years and then every 6 months for the next 3 years post surgery for recurrence.

Overall survival is measured by the time interval between randomisation and date of death from all causes.

Secondary outcome [3]

To demonstrate an acceptable rate of de-escalation in the ctDNA-informed negative cohort.

Timepoint [3]

At interim analysis and end of study

Secondary outcome [4]

To examine the proportion of patients in whom escalated chemotherapy has reversed the ctDNA status from positive to negative post completion of the escalated treatment regime in the ctDNA-informed positive cohort.

Timepoint [4]

At the completion of treatment for all patients randomised to the ctDNA-informed cohort which had a positive ctDNA-1 blood result and were treated with an escalated treatment regimen. The end of treatment (ctDNA-3) sample will be analysed to determine the proportion of patients where the ctDNA status switched from positive to negative following treatment.

Secondary outcome [5]

To compare the 3-year recurrence free survival rates between ctDNA-informed adjuvant therapy (i.e treatment escalation) and standard of care adjuvant therapy approach in patients with POSITIVE post-op ctDNA.

Timepoint [5]

All patients who had a positive pre-treatment ctDNA blood result and have been followed up for recurrence and survival for at least 3 years.

Secondary outcome [6]

To compare the overall survival between ctDNA-informed adjuvant therapy and standard of care adjuvant therapy approach in patients with NEGATIVE post-op ctDNA.

Timepoint [6]

Overall survival in patients with NEGATIVE post-op ctDNA will be assessed in both cohorts of patients at study completion.

Secondary outcome [7]

To compare the overall survival between ctDNA-informed adjuvant therapy and standard of care adjuvant therapy approach in patients with POSITIVE post -op ctDNA.

Timepoint [7]

Overall survival will be assessed for all patients in both cohorts with a positive post-op ctDNA at end of study.

Eligibility

Key inclusion criteria

1. Patients aged greater than or equal to 18 years of age
2. Subjects with curatively resected stage III (Any T, N1 or N2, M0) colon cancer
3. Patients with rectal cancer will be eligible unless they have had pre-operative combined chemotherapy and radiotherapy, or are scheduled for post-operative combined chemotherapy and radiotherapy.
4. A representative tumour sample is available for molecular testing up to 6 weeks after surgery
5. Fit for at least 3 months of fluoropyrimidine adjuvant chemotherapy
6. ECOG performance status 0-2

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

1. History of another primary cancer within the last 3 years, with the exception of non-melanomatous skin cancer and carcinoma in situ
2. Patients with multiple primary colorectal cancers
3. Inadequate organ function:
a. Moderate/severe renal impairment (GFR<30 ml/min), as calculated by the Cockcroft and Gault equation
b. Absolute neutrophil count <1.0x109/L
c. Platelet count <75x109/L
d. Haemoglobin <80 g/L
e. Aspartate aminotransferase/Alanine aminotransferase >2.5 x upper limit of normal
4. Medical or psychiatric condition or occupational responsibilities that may preclude compliance with the protocol

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Allocation to Arm A (Standard of Care) or Arm B (ctDNA-informed) is not concealed.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Dynamic (adaptive) random allocation methods - ie. Minimisation

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Phase 2 / Phase 3

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

The primary analysis will be according to the intention-to-treat (ITT) principal. A secondary analysis of the primary outcome will be performed according to per-protocol population.
Non-inferiority will be declared if the lower bound of the one-sided 97.5% CI for the difference in recurrence-free survival at 3 years post-randomisation is greater than or equal to the margin (=-?%), 7.5. The recurrence free survival proportion will be estimated from the Kaplan-Meier curve. This will be analysed using tests for differences between tow proportions.

ctDNA status at the completion of all treatment for ctDNA-1 positive patients will be summarised using N and percent. Differences between the SOC and ctDNA-informed arms in each cohort will be compared using the Chi-square test. The ctDNA results turn-around time will be summarised using descriptive statistics: the mean, standard deviation (SD), median, minimum, maximum and interquartile range (25th-75th percentiles). The proportion of patients completing planned study treatment will be compared using the chi-square test.

For continuous variables, appropriate multivariate regression (proportional hazards, logistic, linear) will be used, where appropriate. Categorical variables will be evaluated by using chi-squared tests.

Recurrence free survival, overall survival and other time to event endpoints (local control) will be analysed using the method of Kaplan-Meier and (where appropriate) competing risks. Exploratory analyses adjusting for prognostic factors will be performed using proportional hazards regression methods. Results will be expressed as the estimated hazard ratio with the corresponding 95% confidence interval.

For the ctDNA positive cohort, the 12 month recurrence-free survival rates (calculated using the method of Kaplan-Meier) will be compared using tests for the difference between two proportions. Other exploratory analyses will used similar methods as described above.

Subgroups
Analysis of benefit/non-inferiority will also be examined in the high and low clinical risk subgroups.

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

Actual

19/10/2017

Date of last participant enrolment

Anticipated

19/04/2022

Actual

Date of last data collection

Anticipated

19/04/2024

Actual

Sample size

Target

1000

Accrual to date

356

Final

Recruitment in Australia

Recruitment state(s)

NSW,NT,QLD,SA,TAS,WA,VIC

Recruitment hospital [1]

Royal Melbourne Hospital - City campus - Parkville

Recruitment hospital [2]

Western Private Hospital - Footscray

Recruitment hospital [3]

Box Hill Hospital - Box Hill

Recruitment hospital [4]

The Northern Hospital - Epping

Recruitment hospital [5]

Port Macquarie Base Hospital - Port Macquarie

Recruitment hospital [6]

Wollongong Hospital - Wollongong

Recruitment hospital [7]

Flinders Medical Centre - Bedford Park

Recruitment hospital [8]

The Queen Elizabeth Hospital - Woodville

Recruitment hospital [9]

Royal Brisbane & Womens Hospital - Herston

Recruitment hospital [10]

Fiona Stanley Hospital - Murdoch

Recruitment hospital [11]

Newcastle Private Hospital - New Lambton Heights

Recruitment hospital [12]

Western Hospital - Footscray - Footscray

Recruitment hospital [13]

Peter MacCallum Cancer Centre - Melbourne

Recruitment hospital [14]

Melbourne Private Hospital - Parkville

Recruitment hospital [15]

St Vincent's Hospital (Melbourne) Ltd - Fitzroy

Recruitment hospital [16]

Bendigo Health Care Group - Bendigo Hospital - Bendigo

Recruitment hospital [17]

Southwest Health Care - Warrnambool - Warrnambool

Recruitment hospital [18]

Frankston Hospital - Frankston

Recruitment hospital [19]

Ballarat Health Services (Base Hospital) - Ballarat Central

Recruitment hospital [20]

Royal Hobart Hospital - Hobart

Recruitment hospital [21]

Lake Macquarie Private Hospital - Gateshead

Recruitment hospital [22]

Campbelltown Hospital - Campbelltown

Recruitment hospital [23]

Concord Repatriation Hospital - Concord

Recruitment hospital [24]

Liverpool Hospital - Liverpool

Recruitment hospital [25]

Northern Cancer Institute - St Leonards

Recruitment hospital [26]

Goulburn Valley Health - Shepparton campus - Shepparton

Recruitment hospital [27]

The Tweed Hospital - Tweed Heads

Recruitment hospital [28]

Tamworth Rural Referral Hospital - Tamworth

Recruitment hospital [29]

Macquarie University Hospital - Macquarie Park

Recruitment hospital [30]

Gosford Hospital - Gosford

Recruitment hospital [31]

Wyong Public Hospital - Hamlyn Terrace

Recruitment hospital [32]

Echuca Regional Health - Echuca

Recruitment hospital [33]

Nepean Hospital - Kingswood

Recruitment hospital [34]

Epworth Eastern Hospital - Box Hill

Recruitment hospital [35]

Epworth Freemasons (Victoria Parade) - East Melbourne

Recruitment hospital [36]

Epworth Richmond - Richmond

Recruitment hospital [37]

Peninsula Private Hospital - Frankston - Frankston

Recruitment hospital [38]

Katherine Hospital - Katherine

Recruitment hospital [39]

Royal Darwin Hospital - Tiwi

Recruitment postcode(s) [1]

0810 - Tiwi

Recruitment postcode(s) [2]

0850 - Katherine

Recruitment postcode(s) [3]

2065 - St Leonards

Recruitment postcode(s) [4]

2109 - Macquarie Park

Recruitment postcode(s) [5]

2139 - Concord

Recruitment postcode(s) [6]

2170 - Liverpool

Recruitment postcode(s) [7]

2250 - Gosford

Recruitment postcode(s) [8]

2259 - Hamlyn Terrace

Recruitment postcode(s) [9]

2290 - Gateshead

Recruitment postcode(s) [10]

2305 - New Lambton Heights

Recruitment postcode(s) [11]

2340 - Tamworth

Recruitment postcode(s) [12]

2444 - Port Macquarie

Recruitment postcode(s) [13]

2485 - Tweed Heads

Recruitment postcode(s) [14]

2500 - Wollongong

Recruitment postcode(s) [15]

2560 - Campbelltown

Recruitment postcode(s) [16]

2747 - Kingswood

Recruitment postcode(s) [17]

3000 - Melbourne

Recruitment postcode(s) [18]

3002 - East Melbourne

Recruitment postcode(s) [19]

3011 - Footscray

Recruitment postcode(s) [20]

3050 - Parkville

Recruitment postcode(s) [21]

3052 - Parkville

Recruitment postcode(s) [22]

3065 - Fitzroy

Recruitment postcode(s) [23]

3076 - Epping

Recruitment postcode(s) [24]

3121 - Richmond

Recruitment postcode(s) [25]

3128 - Box Hill

Recruitment postcode(s) [26]

3128 - Box Hill

Recruitment postcode(s) [27]

3199 - Frankston

Recruitment postcode(s) [28]

3199 - Frankston

Recruitment postcode(s) [29]

3280 - Warrnambool

Recruitment postcode(s) [30]

3350 - Ballarat Central

Recruitment postcode(s) [31]

3550 - Bendigo

Recruitment postcode(s) [32]

3564 - Echuca

Recruitment postcode(s) [33]

3630 - Shepparton

Recruitment postcode(s) [34]

4029 - Herston

Recruitment postcode(s) [35]

5011 - Woodville

Recruitment postcode(s) [36]

5042 - Bedford Park

Recruitment postcode(s) [37]

6150 - Murdoch

Recruitment postcode(s) [38]

7000 - Hobart

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Christchurch

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Marcus Foundation

Address [1]

1266 W. Paces Ferry Road No. 615
Atlanta, Georgia 30327
USA

Country [1]

United States of America

Primary sponsor type

Other Collaborative groups

Name

Australasian Gastro-Intestinal Trials Group

Address

GI Cancer Institute @Lifehouse
Level 6, 119-143 Missenden Rd
Camperdown NSW 2050

Country

Australia

Secondary sponsor category [1]

Other

Name [1]

The Walter and Eliza Hall Institute of Medical Research

Address [1]

1G Royal Parade
Parkville
VIC 3052

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Melbourne Health

Ethics committee address [1]

Office for Research
The Royal Melbourne Hospital
Level 2 South West
300 Grattan Street
Parkville VIC 3050
Australia

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

30/11/2016

Approval date [1]

22/03/2017

Ethics approval number [1]

HREC/16/MH/388

Ethics committee name [2]

HREC of the Northern Territory Department of Health and the Menzies School of Health Research

Ethics committee address [2]

PO Box 41096
Casuarina NT 0811 Australia

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

01/10/2019

Approval date [2]

11/11/2019

Ethics approval number [2]

HREC-2019-3529

Ethics committee name [3]

Health and Disability Ethics Committees

Ethics committee address [3]

Ministry of Health
133 Molesworth St
PO Box 5013
Wellington 6011
New Zealand

Ethics committee country [3]

New Zealand

Date submitted for ethics approval [3]

25/09/2018

Approval date [3]

04/02/2019

Ethics approval number [3]

18/NTB/159

Summary

Brief summary

The aim of this study is to compare treatment informed by ctDNA results to standard care in patients with stage III colon cancer.

Who is it for?
You may be eligible to join this study if you are aged 18 years or more and have undergone curative surgery for stage III colon cancer.

Study details
All participants in this study will have a blood draw during week 5-6 post surgery for ctDNA analysis. They will then be randomly allocated to one of two treatment groups. One group will receive standard of care treatment as selected by their clinician: either no chemotherapy, single agent fluoropyrimidine chemotherapy or combination fluoropyrimidine plus oxaliplatin chemotherapy. Treatment selection in the other group will be informed by ctDNA blood test results.

All patients will be followed up every 3 months for 2 years, then every 6 months for 3 years in order to evaluate treatment safety and efficacy. Follow-up involves additional blood tests and radiological assessments. It is hoped that the findings from this study will demonstrate that using ctDNA results to help make a decision regarding adjuvant chemotherapy is not inferior to standard of care in terms of recurrence-free survival.

Trial website

none

Trial related presentations / publications

none

Public notes

Contacts

Principal investigator

Name

A/Prof Jeanne Tie

Address

The Walter and Eliza Hall Institute of Medical Research
1G Royal Parade
Parkville
VIC 3052

Country

Australia

Phone

+61 3 9345 2707

Fax

+61 3 9498 2010

jeanne.tie@petermac.org

Contact person for public queries

Name

Dr Marlyse Debrincat

Address

The Walter and Eliza Hall Institute of Medical Research
1G Royal Parade
Parkville
VIC 3052

Country

Australia

Phone

+61 3 9345 2895

Fax

+61 3 9498 2010

marlyse.debrincat@mh.org.au

Contact person for scientific queries

Name

A/Prof Jeanne Tie

Address

The Walter and Eliza Hall Institute of Medical Research
1G Royal Parade
Parkville
VIC 3052

Country

Australia

Phone

+61 3 9 345 2707

Fax

+61 3 9498 2010

jeanne.tie@petermac.org

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

IPD may be collected at a site level. However, IPD will not be made available to the Sponsor. The data that is collected by the Sponsor will not be re-identifiable at the Sponsor level. There are safeguards in place to minimise the risk of a privacy breach. They include analysing the data on an aggregated level and access to the data in a controlled environment with only authorised study personnel. Finally, enabling the availability of IPDs will not help meet the primary and secondary objectives of the study which are dependent on the results from the study population rather than on an individual basis.

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Detecting Liquid Remnants of Solid Tumors: Circulating Tumor DNA Minimal Residual Disease.	2021	https://dx.doi.org/10.1158/2159-8290.CD-21-0634
Embase	Liquid Biopsy Applications in the Clinic.	2020	https://dx.doi.org/10.1007/s40291-019-00444-8
Embase	Refining adjuvant therapy for non-metastatic colon cancer, new standards and perspectives.	2019	https://dx.doi.org/10.1016/j.ctrv.2019.02.002
Embase	Mind the target: Circulating tumour DNA in gastrointestinal malignancies.	2022	https://dx.doi.org/10.1097/CCO.0000000000000846
Embase	Circulating tumor DNA in early-stage colon cancer: ready for prime time or needing refinement?.	2022	https://dx.doi.org/10.1177/17588359221143975
Embase	Patterns of Patient-Reported Chemotherapy-Induced Peripheral Neuropathy in Colorectal Cancer Survivors.	2022	https://dx.doi.org/10.6004/jnccn.2022.7050
Embase	Current Applications of Liquid Biopsy in Gastrointestinal Cancer Disease-From Early Cancer Detection to Individualized Cancer Treatment.	2023	https://dx.doi.org/10.3390/cancers15071924
Dimensions AI	The Future of ctDNA-Defined Minimal Residual Disease: Personalizing Adjuvant Therapy in Colorectal Cancer	2022	https://doi.org/10.1016/j.clcc.2022.03.004
Dimensions AI	Advantages and Challenges of Using ctDNA NGS to Assess the Presence of Minimal Residual Disease (MRD) in Solid Tumors	2021	https://doi.org/10.3390/cancers13225698
Dimensions AI	Circulating Tumor DNA Analyses as Markers of Recurrence Risk and Benefit of Adjuvant Therapy for Stage III Colon Cancer	2019	https://doi.org/10.1001/jamaoncol.2019.3616
Dimensions AI	Evaluation of Comparative Surveillance Strategies of Circulating Tumor DNA, Imaging, and Carcinoembryonic Antigen Levels in Patients With Resected Colorectal Cancer	2022	https://doi.org/10.1001/jamanetworkopen.2022.1093
Dimensions AI	Circulating Tumour DNA to Guide Treatment of Gastrointestinal Malignancies	2020	https://doi.org/10.1159/000509657
Dimensions AI	Postoperative circulating tumor DNA as markers of recurrence risk in stages II to III colorectal cancer	2021	https://doi.org/10.1186/s13045-021-01089-z
Dimensions AI	Utilizing Plasma Circulating Tumor DNA Sequencing for Precision Medicine in the Management of Solid Cancers	2023	https://doi.org/10.4143/crt.2023.446
Dimensions AI	Liquid Biopsy: From Discovery to Clinical Application	2021	https://doi.org/10.1158/2159-8290.cd-20-1311
Dimensions AI	Circulating Tumor DNA Analysis in Colorectal Cancer: From Dream to Reality	2019	https://doi.org/10.1200/po.18.00397
Dimensions AI	Clinical Applications of Minimal Residual Disease Assessments by Tumor-Informed and Tumor-Uninformed Circulating Tumor DNA in Colorectal Cancer	2021	https://doi.org/10.3390/cancers13184547
Dimensions AI	The potential role of minimal/molecular residual disease in colorectal cancer: curative surgery, radiotherapy and beyond	2023	https://doi.org/10.1016/j.jncc.2023.05.005

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically