An observational study in Malignant Polyp, sponsored by Memorial Sloan Kettering Cancer Center. Recruiting at 7 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-14.
Sponsored by Memorial Sloan Kettering Cancer Center · Observational
The purpose of this study is to learn more about malignant colorectal polyps and the risk of the cancer remaining, coming back, or spreading after the polyp is removed. The researchers also want to understand how patients and doctors make decisions about treatment after a malignant polyp is removed.
Additionally, the researcher will collect information medical records, including results from tests, imaging scans, lab work, and pathology reports. The researchers may also collect images from your colonoscopy and copies of pathology slides the polyp. The researchers will also follow the patient's health over time through regular doctor visits. If the patient does not have a scheduled visit, a member of the study team will contact the patient by phone at 1 year, 3 years, and 5 years after the patient joins the study to ask about their health.
Memorial Sloan Kettering Cancer Center is the lead sponsor of 1,930 studies on the registry; 328 are open to participants now.
Of its 129 completed or terminated interventional studies of FDA-regulated products, 66 (51%) have results posted.
Counted across the registry records on this site, refreshed daily.
The following Colorectal Surgery outpatient clinic will be prospectively screened. Other patients identified in other clinics at Memorial Sloan-Kettering Cancer Center who fulfill the eligibility criteria may also be invited to participate.
Criteria:
The term malignant polyp specifically refers to a colorectal lesion with cancer invading the submucosa but not extending into the muscularis propria. These lesions are classified as pT1 in the TNM classification system (24)
Prior Treatment Endoscopic resection of the polypoid lesion-malignant polyp with simple snare polypectomy, conventional endoscopic mucosal resection (EMR), or endoscopic submucosal dissection (ESD) (25).
Risk of residual disease and/or recurrent disease
Residual disease analysis will be limited to patients who underwent surgery (in addition to endoscopic resection). Participants will be evaluable if they undergo adequate pathological assessment of the resected specimen.Adequate assessment is defined as histopathological evaluation of all relevant tissue specimens with a documented report. Participants with incomplete or inadequate pathological assessments will be considered inevaluable. Risk of residual disease will be estimated using the Kaplan-Meier method and reported with 95% confidence intervals. Local recurrence is defined by the reappearance of disease at or near the primary site. The date of diagnosis and anatomical site of recurrence will be documented. Distant recurrence is defined by disease spread to sites distant from the primary lesion. The date of diagnosis and specific sites involved will be documented.
Time frame: 5 years
Plan to share: Yes — Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made following one year after publication and for up to 36 months later. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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Memorial Sloan Kettering Cancer Center