None listed
Conditions
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.
Interventions
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
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.
Sponsors
The Walter and Eliza Hall Institute of Medical Research
Study design
Allocation
Non-randomised trial
Primary purpose
Diagnosis
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
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
Outcome results
None listed