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Trial registered on ANZCTR


Registration number
ACTRN12618001203246p
Ethics application status
Not yet submitted
Date submitted
4/07/2018
Date registered
18/07/2018
Date last updated
18/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Using a new genetic blood test in disease monitoring for lung cancer.
Scientific title
DURATION: Droplet digital PCR – using chromosome rearrangements as tumour-specific markers in disease monitoring for lung cancer. Determining the utility of ctDNA post-surgery as a marker of metastatic or persistent disease up to 36 months after surgery.
Secondary ID [1] 295429 0
None
Universal Trial Number (UTN)
U1111-1216-7147
Trial acronym
DURATION
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Non small-cell lung cancer 308680 0
Condition category
Condition code
Cancer 307610 307610 0 0
Lung - Non small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will evaluate the practicality of droplet digital PCR (ddPCR) assays based on chromosome rearrangements to detect circulating tumour DNA (ctDNA) especially for longitudinal assessment of disease in a cohort of lung cancer patients with early stage tumours that initially undergo surgically resection. The hypothesis is that ctDNA can be detected at an unprecedented level of sensitivity and accuracy by using (ddPCR) assays that use patient tumour-specific rearrangements as highly specific (individualised) tumour biomarkers.
Participants will give consent to provide a tumour sample at time of surgery. 40ml blood samples at day of surgery, day 4, day 30 and then 6 monthly for 36 months. Clinical review including physical exam at 1 month. Clinic review including physical exam and CT Chest scan at 6 months and then 6 monthly for 36 months. Clinic review including physical exam and CT Chest scan at years 4 and 5.
Intervention code [1] 301738 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 306591 0
Determine the utility of circulating tumour DNA (ctDNA) post-surgery as a marker of metastatic or persistent disease assessed by droplet digital PCR.
The utility will be determined by correlating the results of the ddPCR with clinician review and CT Scan at 6 monthy intervals to 36 months and then annually to 5 years.
Timepoint [1] 306591 0
Lung tumour biopsy / at surgery,

Blood sampling for ddPCR testing / Day of surgery, Day 4, Day 30 and 6 monthly to 36 months.

Clinician Review / 30 days

Clinician Review and CT scan / 6 monthly to 36 months and then annually to 5 years
Secondary outcome [1] 349672 0
N/A
Timepoint [1] 349672 0
N/A

Eligibility
Key inclusion criteria
Inclusion criteria:
1. Patient with suspected or proven stage I – IIIA NSCLC requiring surgical resection.
2. Availability of tumour tissue for the purpose of DNA analysis, (either prior to or during surgery) with enough tumour material of at least 50% tumour purity to yield sufficient DNA (1-2ug) for whole genome sequencing
3. Age greater than or equal to 18
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:
1. Persons with a cognitive impairment, intellectual disability or mental illness who are not competent to consent.
2. Patients unfit for lung cancer resection.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
In order to show a clinically important and statistically significant difference to usual clinical follow-up (Type I error probability p=0.05 and power of 80%) we would require 100 patients. Allowing for a 20% attrition rate, we would seek to enroll 120 patients over 2 years.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 11310 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment hospital [2] 11311 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [3] 11312 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [4] 11313 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment postcode(s) [1] 23208 0
3065 - Fitzroy
Recruitment postcode(s) [2] 23209 0
3084 - Heidelberg
Recruitment postcode(s) [3] 23210 0
3000 - Melbourne
Recruitment postcode(s) [4] 23211 0
3050 - Parkville

Funding & Sponsors
Funding source category [1] 300015 0
Government body
Name [1] 300015 0
NHMRC
Address [1] 300015 0
National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
Country [1] 300015 0
Australia
Primary sponsor type
Individual
Name
Associate Professor Alexander Dobrovic
Address
Head, Translational Genomics & Epigenomics Lab
Olivia Newton-John Cancer Research Institute
145 Studley Road
Heidelberg (Melbourne), Victoria 3084
Country
Australia
Secondary sponsor category [1] 299405 0
Individual
Name [1] 299405 0
Associate Professor Gavin Wright
Address [1] 299405 0
Director of Surgical Oncology
St Vincent's Hospital Melbourne
41 Victoria Parade
Fitzroy, Victoria 3065

Country [1] 299405 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 300868 0
St Vincent's Hospital Melbourne Human Research Ethics Committee
Ethics committee address [1] 300868 0
41 Victoria Parade
Fitzroy, Victoria 3065
Ethics committee country [1] 300868 0
Australia
Date submitted for ethics approval [1] 300868 0
18/07/2018
Approval date [1] 300868 0
Ethics approval number [1] 300868 0

Summary
Brief summary
The purpose of this study is to determine the practicality of a new blood test called droplet digital PCR (ddPCR) to detect circulating tumour DNA in early stage lung cancer patients.

Who is it for?
You may be eligible for this study if you are an adult who has suspected or proven non-small cell lung cancer.

Study details
Participants will provide blood samples and a sample of lung tumour at time of surgery. Participants will be reviewed one month post-surgery and then every 6 months for 3 years, with a clinical review, CT scan and blood test completed at each follow up. Participants will be reviewed at 4 and 5 years with a clinical review and CT scan.

It is hoped this research will enable doctors in the future to use this new blood test to better predict outcomes of cancer surgery in order to determine the best post-operative treatment required for each individual participant.

Trial website
N/A
Trial related presentations / publications
N/A
Public notes

Contacts
Principal investigator
Name 85094 0
A/Prof Gavin Wright
Address 85094 0
Director of Surgical Oncology
St. Vincent's Hospital Melbourne
41 Victoria Parade
Fitzroy, Victoria 3065
Country 85094 0
Australia
Phone 85094 0
+61 3 9419 2477
Fax 85094 0
+61 3 9417 1694
Email 85094 0
gavin.wright@svha.org.au
Contact person for public queries
Name 85095 0
A/Prof Gavin Wright
Address 85095 0
Director of Surgical Oncology
St. Vincent's Hospital Melbourne
41 Victoria Parade
Fitzroy, Victoria 3065
Country 85095 0
Australia
Phone 85095 0
+61 3 9419 2477
Fax 85095 0
+61 3 9417 1694
Email 85095 0
gavin.wright@svha.org.au
Contact person for scientific queries
Name 85096 0
A/Prof Alexander Dobrovic
Address 85096 0
Head, Translational Genomics & Epigenomics Lab
Olivia Newton-John Cancer Research Institute
145 Studley Road
Heidelberg (Melbourne), Victoria 3084

Country 85096 0
Australia
Phone 85096 0
+61 3 9496 9689
Fax 85096 0
Email 85096 0
alex.dobrovic@onjcri.org.au

No information has been provided regarding IPD availability
Summary results
No Results