Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001116213p
Ethics application status
Submitted, not yet approved
Date submitted
22/06/2018
Date registered
6/07/2018
Date last updated
6/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Prospective characterisation of a novel circulating tumour-derived DNA methylation assay to monitor tumour burden and response to therapy in metastatic colorectal cancer (CATCHER-1)
Scientific title
Prospective characterisation of a novel circulating tumour-derived DNA methylation assay to monitor tumour burden and response to therapy in metastatic colorectal cancer (CATCHER-1)
Secondary ID [1] 295191 0
None
Universal Trial Number (UTN)
Trial acronym
CATCHER-1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
metastatic colorectal cancer 308325 0
Condition category
Condition code
Cancer 307325 307325 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is an observational trial of a potential biomarker, with no influence on the patients' treatment and is therefore non-interventional

1. Colvera and CEA will be taken at the following time points
a. Cohort A (first 5 patients): daily (Mon-Fri) for 1 week prior to starting systemic therapy, and daily (Mon-Fri) during cycle 1 week 1 of systemic therapy. Then every 2 weeks for 12 weeks and every 4 weeks thereafter. An interim analysis will be undertaken to evaluate preliminary results to determine the frequency of testing in subsequent cohorts.
b. Cohort B (next 20 patients): at baseline (prior to commencement of systemic therapy), then frequency of testing is to be determined, likely every 2 weeks for 12 weeks and every 4 weeks thereafter.
c. Cohort C (next 25 patients): at baseline (prior to commencement of systemic therapy), then frequency as determined by the emerging data from the first 2 cohorts, likely every 4 to 6 weeks.

Upon cessation of all anti-cancer therapy (i.e. patients receiving best supportive care only), Colvera and CEA blood testing will become voluntary only up until death for a maximum of 20 years.
Intervention code [1] 301529 0
Not applicable
Comparator / control treatment
CtDNA Colvera test will be compared to standard measures of CAE and radiographic imaging
Control group
Active

Outcomes
Primary outcome [1] 306289 0
Evaluate the quantitative changes of Colvera as a marker of response to therapy as compared with standard measures including CEA and radiographic imaging in metastatic colorectal cancer. CEA and radiographic imaging are standard measures
Timepoint [1] 306289 0
Cohort A (first 5 patients): daily for 1 week prior to sytemic therapy, daily for 1st week of therapy, then every 2 weeks for 12 weeks and every 4 weeks thereafter for a maximum of 3 years.
Cohort B (next 20 patients): at baseline (prior to therapy), then every 2 weeks for 12 weeks and every 4 weeks thereafter for a maximum of 3 years
Cohort C (next 25 patients): at baseline (prior to treatment) then every 4-6 weeks for a maximum of 3 years.
Primary outcome [2] 306453 0
To evaluate the prognostic value of Colvera as determined by survival outcomes
Timepoint [2] 306453 0
Survival follow-up will continue every 3 months until death.
Secondary outcome [1] 348088 0
Evaluate the time course of changes in Colvera and compare it to changes in standard measures of response including CEA and radiographic imaging.
Timepoint [1] 348088 0
Cohort A (first 5 patients): daily for 1 week prior to sytemic therapy, daily for 1st week of therapy, then every 2 weeks for 12 weeks and every 4 weeks thereafter for a maximum of 3 years.
Cohort B (next 20 patients): at baseline (prior to therapy), then every 2 weeks for 12 weeks and every 4 weeks thereafter for a maximum of 3 years
Cohort C (next 25 patients): at baseline (prior to treatment) then every 4-6 weeks for a maximum of 3 years.
Secondary outcome [2] 348090 0
Evaluate the dynamic range of the Colvera assay.
We are assessing quantitative range of Colvera values, testing in three patient cohorts
Timepoint [2] 348090 0
Cohort A (first 5 patients): daily for 1 week prior to sytemic therapy, daily for 1st week of therapy, then every 2 weeks for 12 weeks and every 4 weeks thereafter for a maximum of 3 years.
Cohort B (next 20 patients): at baseline (prior to therapy), then every 2 weeks for 12 weeks and every 4 weeks thereafter for a maximum of 3 years
Cohort C (next 25 patients): at baseline (prior to treatment) then every 4-6 weeks for a maximum of 3 years.
Secondary outcome [3] 348091 0
Determine the sensitivity of Colvera in various advanced or metastatic disease scenarios including 1st line therapy through to refractory disease. The sensitivity will be assessed by measuring the levels of DNA methylation in comparison with standard measures CT imaging and CEA.
Timepoint [3] 348091 0
Cohort A (first 5 patients): daily for 1 week prior to sytemic therapy, daily for 1st week of therapy, then every 2 weeks for 12 weeks and every 4 weeks thereafter for a maximum of 3 years.
Cohort B (next 20 patients): at baseline (prior to therapy), then every 2 weeks for 12 weeks and every 4 weeks thereafter for a maximum of 3 years
Cohort C (next 25 patients): at baseline (prior to treatment) then every 4-6 weeks for a maximum of 3 years.
Secondary outcome [4] 348599 0
Determine the specificity of Colvera in various advanced or metastatic disease scenarios including 1st line therapy through to refractory disease. The specificity will be assessed by measuring the levels of DNA methylation in comparison to standard measures CT imaging and CEA.
Timepoint [4] 348599 0
1. Colvera and CEA will be taken at the following time points
a. Cohort A (first 5 patients): daily (Mon-Fri) for 1 week prior to starting systemic therapy, and daily (Mon-Fri) during cycle 1 week 1 of systemic therapy. Then every 2 weeks for 12 weeks and every 4 weeks thereafter. An interim analysis will be undertaken to evaluate preliminary results to determine the frequency of testing in subsequent cohorts.
b. Cohort B (next 20 patients): at baseline (prior to commencement of systemic therapy), then frequency of testing is to be determined, likely every 2 weeks for 12 weeks and every 4 weeks thereafter.
c. Cohort C (next 25 patients): at baseline (prior to commencement of systemic therapy), then frequency as determined by the emerging data from the first 2 cohorts, likely every 4 to 6 weeks

Eligibility
Key inclusion criteria
18 years or over.
Patient with metastatic adenocarcinoma of colon or rectum who are commencing a new line of systemic therapy.
ECOG 0-2 and candidates for systemic therapy.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Medical or psychiatric condition that would preclude compliance with the protocol.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
16/07/2018
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 11134 0
Monash Medical Centre - Moorabbin campus - East Bentleigh
Recruitment postcode(s) [1] 22952 0
3165 - East Bentleigh

Funding & Sponsors
Funding source category [1] 299778 0
Commercial sector/Industry
Name [1] 299778 0
Clinical Genomics
Country [1] 299778 0
Australia
Primary sponsor type
Hospital
Name
Monash Health
Address
246 Clayton Road, Clayton, Victoria 3168
Country
Australia
Secondary sponsor category [1] 299235 0
None
Name [1] 299235 0
Address [1] 299235 0
Country [1] 299235 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 300668 0
Monash Health Human Research Ethics Committee
Ethics committee address [1] 300668 0
Ethics committee country [1] 300668 0
Australia
Date submitted for ethics approval [1] 300668 0
17/04/2018
Approval date [1] 300668 0
Ethics approval number [1] 300668 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 84402 0
Dr Daphne Day
Address 84402 0
Monash Health, 246 Clayton Road, Clayton, Victoria 3168
Country 84402 0
Australia
Phone 84402 0
+61 3 8572 2928
Fax 84402 0
Email 84402 0
daphne.day@monash.edu
Contact person for public queries
Name 84403 0
Daphne Day
Address 84403 0
Monash Health, 246 Clayton Road, Clayton, Victoria 3168
Country 84403 0
Australia
Phone 84403 0
+61 3 8572 2928
Fax 84403 0
Email 84403 0
daphne.day@monash.edu
Contact person for scientific queries
Name 84404 0
Maja Green
Address 84404 0
lvl 7, Monash Health Translation Pecinct, 246 Clayton Road, Clayton, Victoria 3168
Country 84404 0
Australia
Phone 84404 0
+61 3 8572 2372
Fax 84404 0
Email 84404 0
maja.green@monash.edu

No information has been provided regarding IPD availability


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
No additional documents have been identified.