A Prospective Registry of Patients With Endoscopically Resected Malignant Colorectal Polyps (pT1 Colorectal Cancer)

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMemorial Sloan Kettering Cancer Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial population

Adults with a single endoscopically resected malignant colorectal polyp (pT1 colorectal cancer) evaluated at Memorial Sloan Kettering Cancer Center. Patients seen in the Colorectal Surgery outpatient clinics at MSK Manhattan and MSK regional sites will be prospectively screened; eligible patients identified in other MSK clinics may also be invited to participate. Patients may enroll regardless of pathologic risk features and regardless of whether they choose surgery or nonoperative surveillance.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Questionnaires

    Other intervention

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

Treatment groups

500 Participants
are divided into 2 treatment groups
Group A: Immediate surgery1 intervention
Group B: Nonoperative surveillance1 intervention

Trial outcomes

Primary outcomes

1

Risk of residual disease and/or recurrent disease

Residual disease is defined as cancer in the bowel wall or regional lymph nodes found at surgery performed after endoscopic resection (assessed in participants who undergo surgery). Recurrent disease is defined as local or distant reappearance of cancer during follow-up (assessed in all participants). Rates will be estimated using the Kaplan-Meier method with 95% confidence intervals.

Time frame
Up to 5 years

Secondary outcomes

1

Disease-free survival

time from endoscopic removal of the malignant polyp to local recurrence, distant recurrence, or death

Time frame
Up to 5 years
2

Overall survival

time from endoscopic removal to death from any cause

Time frame
Up to 5 years
3

Local recurrence rate

reappearance of cancer at or near the site of the original polyp

Time frame
Up to 5 years
4

Distant recurrence rate

spread of cancer to sites distant from the original polyp

Time frame
Up to 5 years

Other outcomes

Sponsors and contacts

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