Malignant Polyp Registry

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.

Study Overview

• Status: Recruiting
• Conditions: Malignant Polyp

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Georgios Karagkounis, MD; Phone Number: 212-639-2269; Email: karagkog@mskcc.org
• Study Contact Backup: Name: Julio Garcia-Aguilar, MD, PhD; Phone Number: 212 639 5117

Study Locations

• United States
  • New Jersey
    • Basking Ridge, New Jersey, United States, 07920
      • Recruiting
      • Memorial Sloan Kettering Basking Ridge
      • Contact: Georgios Karagkounis, MD; Phone Number: 212-639-2269
    • Middletown, New Jersey, United States, 07748
      • Recruiting
      • Memorial Sloan Kettering Monmouth
      • Contact: Georgios Karagkounis, MD; Phone Number: 212-639-2269
    • Montvale, New Jersey, United States, 07645
      • Recruiting
      • Memorial Sloan Kettering Bergen
      • Contact: Georgios Karagkounis, MD; Phone Number: 212-639-2269
  • New York
    • Commack, New York, United States, 11725
      • Recruiting
      • Memorial Sloan Kettering Suffolk - Commack
      • Contact: Georgios Karagkounis, MD; Phone Number: 212-639-2269
    • Harrison, New York, United States, 10604
      • Recruiting
      • Memorial Sloan Kettering Westchester
      • Contact: Georgios Karagkounis, MD; Phone Number: 212-639-2269
    • New York, New York, United States, 10065
      • Recruiting
      • Memorial Sloan Kettering Cancer Center
      • Contact: Georgios Karagkounis, MD; Phone Number: 212-639-2269
      • Contact: Julio Garcia-Aguilar, MD,PhD; Phone Number: 212-639-5117
    • Uniondale, New York, United States, 11553
      • Recruiting
      • Memorial Sloan Kettering Nassau
      • Contact: Georgios Karagkounis, MD; Phone Number: 212-639-2269

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	5 years

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Investigators: Principal Investigator: Georgios Karagkounis, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): May 19, 2026
• Primary Completion (Estimated): May 19, 2029
• Study Completion (Estimated): May 19, 2029

Study Registration Dates

• First Submitted: May 20, 2026
• First Submitted That Met QC Criteria: May 27, 2026
• First Posted (Actual): June 1, 2026

Study Record Updates

• Last Update Posted (Actual): July 14, 2026
• Last Update Submitted That Met QC Criteria: July 13, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 26-176

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No