Malignant Colorectal PolypNCT07619079
Malignant Polyp Registry
An observational study of Malignant Colorectal Polyp and Colorectal Cancer, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Colorectal Polyp, Colorectal Cancer, T1 Colorectal Cancer
- What is being tested?
- Questionnaires
- How many people
- 500 participants
- Where
- 7 sitesUnited States
- Study dates
- 19 May 2026to 19 May 2029
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- 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
Who cannot join
- °More than one malignant polyp
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Julio Garcia-Aguilar, MD, PhD contact
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920
Georgios Karagkounis, MD, 212-639-2269
- Recruiting
Memorial Sloan Kettering Suffolk - Commack
Commack, New York, 11725
Georgios Karagkounis, MD, 212-639-2269
- Recruiting
Memorial Sloan Kettering Westchester
Harrison, New York, 10604
Georgios Karagkounis, MD, 212-639-2269
- Recruiting
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748
Georgios Karagkounis, MD, 212-639-2269
- Recruiting
Memorial Sloan Kettering Bergen
Montvale, New Jersey, 07645
Georgios Karagkounis, MD, 212-639-2269
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Georgios Karagkounis, MD, 212-639-2269
Julio Garcia-Aguilar, MD,PhD, 212-639-5117
- Recruiting
Memorial Sloan Kettering Nassau
Uniondale, New York, 11553
Georgios Karagkounis, MD, 212-639-2269
About this study
Official title: A Prospective Registry of Patients With Endoscopically Resected Malignant Colorectal Polyps (pT1 Colorectal Cancer): Risk of Residual and Recurrent Disease, and Patient and Provider Decision-Making
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.
- Being tested
- Questionnaires
- Keywords
- PT1, early colorectal cancer, polypectomy, endoscopic submucosal dissection, endoscopic mucosal resection, surveillance, watch and wait, organ preservation, shared decision-making, registry, 26-176
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
risk-perception/decision-making questionnaire and validated risk-attitude scales, completed once during evaluation (both cohorts)
| Study group | Role | What they receive |
|---|---|---|
| Immediate surgery | patients who choose colorectal resection after endoscopic removal of a malignant polyp Receives: Other: Questionnaires | |
| Nonoperative surveillance | patients who choose surveillance without surgery Receives: Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 5 years
Secondary outcomes (6)
Disease-free survival
time from endoscopic removal of the malignant polyp to local recurrence, distant recurrence, or death
Measured: Up to 5 years
Overall survival
time from endoscopic removal to death from any cause
Measured: Up to 5 years
Local recurrence rate
reappearance of cancer at or near the site of the original polyp
Measured: Up to 5 years
Distant recurrence rate
spread of cancer to sites distant from the original polyp
Measured: Up to 5 years
Factors associated with patient treatment choice
association of risk perception, priorities and risk attitudes (study questionnaire, PRT, HRAS-6, DOSPERT-M) with choice of surgery vs surveillance
Measured: at enrollment
Accuracy of surgeon risk assessment
Concordance between surgeons' estimated risk of residual or recurrent disease at diagnosis (before and after multidisciplinary discussion) and observed outcomes
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study start19 May 2026
- Primary completion19 May 2029 (estimated)
- Study completion19 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Colorectal PolypStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Georgios Karagkounis, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07619079
- Sponsor's protocol ID
- 26-176
- Status last verified
- Oct 2026
- First submitted
- 20 May 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Registry of Patients With Endoscopically Resected Malignant Colorectal Polyps (pT1 Colorectal Cancer): Risk of Residual and Recurrent Disease, and Patient and Provider Decision-Making
- ClinicalTrials.gov ID
- NCT07619079
- Acronym / sponsor ID
- 26-176
- Keywords
- PT1, early colorectal cancer, polypectomy, endoscopic submucosal dissection, endoscopic mucosal resection, surveillance, watch and wait, organ preservation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 19 May 2026 (actual)
- Primary completion
- 19 May 2029 (estimated)
- Study completion
- 19 May 2029 (estimated)
- First posted
- 1 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate surgery | – | Other: Questionnairespatients who choose colorectal resection after endoscopic removal of a malignant polyp |
| Nonoperative surveillance | – | Other: Questionnairespatients who choose surveillance without surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- °More than one malignant polyp
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnairesrisk-perception/decision-making questionnaire and validated risk-attitude scales, completed once during evaluation (both cohorts) | Other | Immediate surgery, Nonoperative surveillance |
Primary outcome
Risk of residual disease and/or recurrent disease
Time frame: Up to 5 years
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.
6 secondary outcomes
Disease-free survival
Time frame: Up to 5 years
Overall survival
Time frame: Up to 5 years
Local recurrence rate
Time frame: Up to 5 years
Distant recurrence rate
Time frame: Up to 5 years
Factors associated with patient treatment choice
Time frame: at enrollment
Accuracy of surgeon risk assessment
Time frame: Up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Julio Garcia-Aguilar, MD, PhD contact
Georgios Karagkounis, MD principal investigator
Memorial Sloan Kettering Cancer Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malignant Colorectal Polyp and Colorectal Cancer, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Georgios Karagkounis, MD (212-639-2269, karagkog@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Risk of residual disease and/or recurrent disease (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.