Recruiting

Observational Study

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT07619079

Conditions

Malignant Colorectal Polyp

Colorectal Cancer

T1 Colorectal Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Questionnaires

Study Details

Brief summary:

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.

Conditions

Malignant Colorectal Polyp

Colorectal Cancer

T1 Colorectal Cancer

Study ID

NCT07619079

Start date

May 19, 2026

Status verified date

Oct, 2026

Completion date

May 19, 2029

Anticipated

Primary completion date

May 19, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

\- More than one malignant polyp

Study Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Arms

Immediate surgery

patients who choose colorectal resection after endoscopic removal of a malignant polyp

Nonoperative surveillance

patients who choose surveillance without surgery

Interventions

Questionnaires

risk-perception/decision-making questionnaire and validated risk-attitude scales, completed once during evaluation (both cohorts)

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Georgios Karagkounis, MD

212-639-2269karagkog@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

Oct 22, 2026

Last verified

Oct, 2026

Keywords

  • PT1
  • early colorectal cancer
  • polypectomy
  • endoscopic submucosal dissection
  • endoscopic mucosal resection
  • surveillance
  • watch and wait
  • organ preservation
  • shared decision-making
  • registry
  • 26-176

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-10-22. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.