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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)
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Scientific title
Exploring the Utility of Peritoneal Tumour DNA to Detect Clinically Occult Peritoneal Metastasis in Locally Advanced Colon Cancer (DETECT-PM) in adults
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Secondary ID [1]
312723
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DETECT-PM
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Colon Cancer
334745
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Condition category
Condition code
Cancer
331306
331306
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0
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Bowel - Back passage (rectum) or large bowel (colon)
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
329247
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Early detection / Screening
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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The primary outcome is peritoneal recurrence-free survival.
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Assessment method [1]
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Time-to-event outcomes will be compared using the Cox proportional-hazards model.
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Timepoint [1]
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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
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Secondary outcome [1]
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recurrence-free survival,
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Assessment method [1]
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Recurrence free survival will be assessed by 6 monthly CT scans and CEAs for the first two years then yearly between years 3-5.
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Timepoint [1]
438464
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Recurrence free survival will be assessed by 6 monthly CT scans and CEAs for the first two years then yearly between years 3-5.
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Secondary outcome [2]
439131
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overall survival
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Assessment method [2]
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Time-to-event outcomes will be illustrated using Kaplan-Meier plots with 95% confidence intervals. Participants will be followed up for survival every 6 months.
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Timepoint [2]
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Participants will be followed up every 6 months for survival status until 5 years post surgery or death whichever occurs first.
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Secondary outcome [3]
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time-to-peritoneal recurrence.
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Assessment method [3]
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Time-to-event outcomes will be compared using the Cox proportional-hazards model.
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Timepoint [3]
439132
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Peritoneal recurrence will be assessed by 6 monthly CT scans and CEAs for the first two years then yearly between years 3-5.
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Diagnosis
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
16/10/2024
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Actual
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Date of last participant enrolment
Anticipated
31/12/2026
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Actual
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Date of last data collection
Anticipated
31/12/2031
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Actual
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Sample size
Target
100
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Funding & Sponsors
Funding source category [1]
317152
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Charities/Societies/Foundations
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Name [1]
317152
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Ramsay Hospital Research Foundation - Translational Challenge Grant
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Address [1]
317152
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Country [1]
317152
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Australia
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Primary sponsor type
Other
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Name
The Walter and Eliza Hall Institute of Medical Research
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Address
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Country
Australia
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Secondary sponsor category [1]
319424
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None
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Name [1]
319424
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Address [1]
319424
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Country [1]
319424
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
315903
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The Royal Melbourne Hospital Human Research Ethics Committee
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Ethics committee address [1]
315903
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https://www.thermh.org.au/research/researchers/ethics
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Ethics committee country [1]
315903
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Australia
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Date submitted for ethics approval [1]
315903
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29/11/2023
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Approval date [1]
315903
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02/05/2024
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Ethics approval number [1]
315903
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Summary
Brief summary
The DETECT-PM study aims to determine the sensitivity and specificity of tumour DNA detection in peritoneal fluid collected at the time of surgery for non-metastatic locally advanced (cT4, N0-2, M0) or perforated colon cancer to predict for peritoneal recurrence. Who is it for? You may be eligible for this study if you are a male or female over the age of 18 and have histologically confirmed colon adenocarcinoma that is amenable to curative intent surgery. Study details: Blood samples will also 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 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. It is hoped that findings from this study will provide opportunity for earlier intervention to prevent peritoneal recurrence through the detection of clinically occult peritoneal metastasis.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Jeanne Tie
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Address
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WEHI, 1G Royal Pde, Parkville, VIC 3052
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Country
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Australia
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Phone
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+61 3 93452895
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Marlyse Debrincat
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Address
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WEHI, 1G Royal Pde, Parkville, VIC 3052
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Country
136159
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Australia
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Phone
136159
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+61 3 93452895
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Fax
136159
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Email
136159
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[email protected]
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Contact person for scientific queries
Name
136160
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Jeanne Tie
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Address
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WEHI, 1G Royal Pde, Parkville, VIC 3052
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Country
136160
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Australia
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Phone
136160
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+61 3 93452895
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Fax
136160
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Email
136160
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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.
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