About this trial
The purpose of this study is to learn more about malignant colorectal polyps (early colorectal cancers removed during colonoscopy) and the risk that cancer remains, comes back, or spreads after the polyp is removed. The researchers also want to understand how patients and doctors make decisions about whether to have surgery or to be followed closely without surgery after a malignant polyp is removed.
This is an observational study. Participants will not receive any study treatment, and their care will be decided by them and their doctors as usual. The researchers will collect information from participants' medical records, including test results, imaging scans, lab work, and pathology reports, and may collect images from colonoscopy and copies of the pathology slides of the polyp. Participants will be asked to complete short questionnaires about how they view their risk and what influenced their treatment decision. The researchers will follow participants' health over time through their regular doctor visits; if no visit is scheduled, a member of the study team will contact participants by phone at 1, 3, and 5 years after they join the study.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 years or older
A single malignant colorectal polyp, defined as a colorectal adenocarcinoma invading the submucosa but not the muscularis propria (pT1), arising in an adenomatous or serrated polyp
Endoscopic resection of the malignant polyp by snare polypectomy, endoscopic mucosal resection (EMR), or endoscopic submucosal dissection (ESD)
Pathologic confirmation of the malignant polyp within 90 days before enrollment
Disqualifiers
None
Trial population
Adults with a single endoscopically resected malignant colorectal polyp (pT1 colorectal cancer) evaluated at Memorial Sloan Kettering Cancer Center. Patients seen in the Colorectal Surgery outpatient clinics at MSK Manhattan and MSK regional sites will be prospectively screened; eligible patients identified in other MSK clinics may also be invited to participate. Patients may enroll regardless of pathologic risk features and regardless of whether they choose surgery or nonoperative surveillance.
Trial design
Cohort
Prospective
Treatments tested in this trial
Questionnaires
Other interventionrisk-perception/decision-making questionnaire and validated risk-attitude scales, completed once during evaluation (both cohorts)
Treatment groups
Trial outcomes
Primary outcomes
Risk of residual disease and/or recurrent disease
Residual disease is defined as cancer in the bowel wall or regional lymph nodes found at surgery performed after endoscopic resection (assessed in participants who undergo surgery). Recurrent disease is defined as local or distant reappearance of cancer during follow-up (assessed in all participants). Rates will be estimated using the Kaplan-Meier method with 95% confidence intervals.
Secondary outcomes
Disease-free survival
time from endoscopic removal of the malignant polyp to local recurrence, distant recurrence, or death
Overall survival
time from endoscopic removal to death from any cause
Local recurrence rate
reappearance of cancer at or near the site of the original polyp
Distant recurrence rate
spread of cancer to sites distant from the original polyp
Sponsors and contacts
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