Recruiting

Observational StudyMalignant Polyp Registry

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT07619079

Conditions

Malignant Polyp

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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.

Conditions

Malignant Polyp

Study ID

NCT07619079

Start date

May 19, 2026

Status verified date

Jul, 2026

Completion date

May 19, 2029

Anticipated

Primary completion date

May 19, 2029

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

Risk of residual disease and/or recurrent disease [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Georgios Karagkounis, MD

212-639-2269 karagkog@mskcc.org

Julio Garcia-Aguilar, MD, PhD

212 639 5117

Locations

Memorial Sloan Kettering Basking Ridge

Recruiting

Basking Ridge, New Jersey, United States, 07920

Contacts

Georgios Karagkounis, MD

212-639-2269

Memorial Sloan Kettering Monmouth

Recruiting

Middletown, New Jersey, United States, 07748

Contacts

Georgios Karagkounis, MD

212-639-2269

Memorial Sloan Kettering Bergen

Recruiting

Montvale, New Jersey, United States, 07645

Contacts

Georgios Karagkounis, MD

212-639-2269

Memorial Sloan Kettering Suffolk - Commack

Recruiting

Commack, New York, United States, 11725

Contacts

Georgios Karagkounis, MD

212-639-2269

Memorial Sloan Kettering Westchester

Recruiting

Harrison, New York, United States, 10604

Contacts

Georgios Karagkounis, MD

212-639-2269

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Georgios Karagkounis, MD

212-639-2269

Julio Garcia-Aguilar, MD,PhD

212-639-5117

Memorial Sloan Kettering Nassau

Recruiting

Uniondale, New York, United States, 11553

Contacts

Georgios Karagkounis, MD

212-639-2269

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

Jul 14, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-07-14.