Malignant Polyp Registry
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Malignant Polyp. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Primary outcome measures
- Risk of residual disease and/or recurrent disease [Time frame: 5 years]
Eligibility criteria
Criteria:
- Documentation of Disease
- Patients must have one malignant polyp, pathologically confirmed within 90 days of enrollment. Patients with multiple malignant polyps are not eligible.
- Definition of Disease Colorectal carcinoma (CRC) develops within serrated or adenomatous polyps. Early CRC represents invasion into the submucosa and frequently presents within the precursor polyp which is termed a 'malignant polyp'(23).
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).
- Age ≥ 18
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 7 centers
- Memorial Sloan Kettering Basking Ridge — Basking Ridge
- Memorial Sloan Kettering Monmouth — Middletown
- Memorial Sloan Kettering Bergen — Montvale
- Memorial Sloan Kettering Suffolk - Commack — Commack
- Memorial Sloan Kettering Westchester — Harrison
- Memorial Sloan Kettering Cancer Center — New York
- Memorial Sloan Kettering Nassau — Uniondale
Identifiers
NCT: NCT07619079 · 26-176