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Trial registered on ANZCTR


Registration number
ACTRN12624001164583
Ethics application status
Approved
Date submitted
9/08/2024
Date registered
24/09/2024
Date last updated
24/09/2024
Date data sharing statement initially provided
24/09/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Exploring the Utility of Peritoneal Tumour DNA to Detect Clinically Occult Peritoneal Metastasis in Locally Advanced Colon Cancer (DETECT-PM)
Scientific title
Exploring the Utility of Peritoneal Tumour DNA to Detect Clinically Occult Peritoneal Metastasis in Locally Advanced Colon Cancer (DETECT-PM) in adults
Secondary ID [1] 312723 0
DETECT-PM
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colon Cancer 334745 0
Condition category
Condition code
Cancer 331306 331306 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants with non-metastatic resectable colon cancer who have a high risk of peritoneal recurrence, defined as those with perforation or clinical T4 disease will have peritoneal fluid collected at the time of surgery.

This study aims to determine the sensitivity and specificity of tumour DNA detection in peritoneal fluid (peritoneal tumour DNA, ptDNA) to predict for peritoneal recurrence..

Blood samples will be collected pre-surgery, 4-6 weeks post surgery, 12 months post surgery and at recurrence (if applicable) for circulating tumour DNA (ctDNA) analysis.

Participants will be followed up for 5 years post surgery.
Intervention code [1] 329247 0
Early detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 339070 0
The primary outcome is peritoneal recurrence-free survival.
Timepoint [1] 339070 0
Peritoneal recurrence free survival will be assessed by 6 monthly CT scans and CEAs for the first two years then yearly between years 3-5.

A ctDNA test will be collected pre-surgery, 4-6 weeks post surgery, 12 months post surgery and at recurrence and a peritoneal lavage will be collected at time of surgery to detect ptDNA. In a small cohort of patients, another peritoneal lavage will be collected after treatment. Both the ctDNA and ptDNA tests will not be analysed in real time so will not be used to inform the primary outcome.

The cut-off date for primary analysis will be when the final patient enrolled has been followed up for 24 months
Secondary outcome [1] 438464 0
recurrence-free survival,
Timepoint [1] 438464 0
Recurrence free survival will be assessed by 6 monthly CT scans and CEAs for the first two years then yearly between years 3-5.
Secondary outcome [2] 439131 0
overall survival
Timepoint [2] 439131 0
Participants will be followed up every 6 months for survival status until 5 years post surgery or death whichever occurs first.
Secondary outcome [3] 439132 0
time-to-peritoneal recurrence.
Timepoint [3] 439132 0
Peritoneal recurrence will be assessed by 6 monthly CT scans and CEAs for the first two years then yearly between years 3-5.

Eligibility
Key inclusion criteria
• Histological confirmed colon adenocarcinoma that is amenable to curative intent surgery
• Evidence of perforation as determined by imaging or the surgeon at the time of resection. Perforation is defined as tumour perforation, perforation of the efferent bowel, or a peri-tumoural abscess.
• For patients without evidence of perforation, clinical T2-T4 tumour of the colon will be enrolled initially, but only those with clinical T4 disease at the time of surgery (as determined by the surgeon at the beginning of surgery) will be eligible for the study
• Staging imaging (CT +/- PET) within 8 weeks of surgery showing no metastatic disease.
• Patients with synchronous localised peritoneal metastatic disease (detected at the time of surgery) that is fully resected at the time of primary tumour resection will be allowed (maximum 10 patients)
• ECOG performance status 0-2
• Patients with life expectancy of at least 2 years
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Patients with widespread or unresectable synchronous metastatic peritoneal disease
• Patients with a colorectal cancer metastases (non-peritoneal) - resectable and unresectable
• Patients with rectal cancer
• Patients treated with pre-op radiation or chemo-radiation
• Concurrent or previous other malignancy within 2 years of study entry, except curatively treated basal or squamous cell skin cancer, prostate intraepithelial neoplasm, carcinoma in-situ of the cervix, Bowen’s disease or prostate cancer with a Gleason score =6.
• Pregnant or lactating women
• Medical or psychiatric condition or occupational responsibilities that may preclude compliance with the protocol

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
16/10/2024
Actual
Date of last participant enrolment
Anticipated
31/12/2026
Actual
Date of last data collection
Anticipated
31/12/2031
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC

Funding & Sponsors
Funding source category [1] 317152 0
Charities/Societies/Foundations
Name [1] 317152 0
Ramsay Hospital Research Foundation - Translational Challenge Grant
Country [1] 317152 0
Australia
Primary sponsor type
Other
Name
The Walter and Eliza Hall Institute of Medical Research
Address
Country
Australia
Secondary sponsor category [1] 319424 0
None
Name [1] 319424 0
Address [1] 319424 0
Country [1] 319424 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315903 0
The Royal Melbourne Hospital Human Research Ethics Committee
Ethics committee address [1] 315903 0
Ethics committee country [1] 315903 0
Australia
Date submitted for ethics approval [1] 315903 0
29/11/2023
Approval date [1] 315903 0
02/05/2024
Ethics approval number [1] 315903 0

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

Contacts
Principal investigator
Name 136158 0
Dr Jeanne Tie
Address 136158 0
WEHI, 1G Royal Pde, Parkville, VIC 3052
Country 136158 0
Australia
Phone 136158 0
+61 3 93452895
Fax 136158 0
Email 136158 0
[email protected]
Contact person for public queries
Name 136159 0
Marlyse Debrincat
Address 136159 0
WEHI, 1G Royal Pde, Parkville, VIC 3052
Country 136159 0
Australia
Phone 136159 0
+61 3 93452895
Fax 136159 0
Email 136159 0
[email protected]
Contact person for scientific queries
Name 136160 0
Jeanne Tie
Address 136160 0
WEHI, 1G Royal Pde, Parkville, VIC 3052
Country 136160 0
Australia
Phone 136160 0
+61 3 93452895
Fax 136160 0
Email 136160 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.