Clinical Outcomes After Non-curative Endoscopic Resection in Early Colorectal Cancer: A Multicenter Study

April 14, 2026 updated by: Nanfang Hospital, Southern Medical University

This multicenter study aims to evaluate clinical outcomes and optimize management strategies in patients with early colorectal cancer who undergo non-curative endoscopic resection.

Patients with non-curative resection following endoscopic treatment will be enrolled across multiple centers and managed according to real-world clinical decisions, including additional surgery or surveillance. Baseline demographic, endoscopic, and pathological characteristics will be systematically collected.

The primary objective is to compare recurrence and survival outcomes between different management strategies. Secondary objectives include identifying prognostic factors associated with recurrence and developing a risk stratification model to guide individualized treatment decisions.

All participants will undergo standardized follow-up according to clinical guidelines. This study is expected to provide real-world evidence to refine risk assessment, reduce unnecessary surgery, and improve personalized management for patients with early colorectal cancer after non-curative endoscopic resection.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China
        • Recruiting
        • Nanfang Hospital, Southern Medical University
        • Contact:
      • Shenzhen, Guangdong, China
        • Recruiting
        • Shenzhen Longgang District People's Hospital
        • Contact:
    • Guangzhou
      • Haizhu, Guangzhou, China, Guangdong
        • Recruiting
        • The second Affiliated Hospital of Guangzhou Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

This multicenter cohort study includes adult patients with early colorectal cancer who underwent non-curative endoscopic resection. Participants are stratified into additional surgery and surveillance groups based on post-resection management strategies. Comprehensive clinicopathological characteristics and follow-up data are collected to evaluate recurrence patterns, survival outcomes, and to develop and validate a risk prediction model.

Description

Inclusion Criteria:

  • Age ≥18 years;
  • Patients with early colorectal cancer confirmed by histopathology;
  • Patients who underwent endoscopic resection (including EMR, ESD, or equivalent techniques);
  • Pathological diagnosis indicating non-curative resection, defined by the presence of at least one of the following: positive resection margin, submucosal invasion depth >1000 μm, poor differentiation, lymphovascular invasion, perineural invasion, or high-grade tumor budding;
  • Availability of complete clinicopathological and follow-up data;
  • Patients managed with either additional surgery or surveillance after endoscopic resection.

Exclusion Criteria:

  • Patients with synchronous advanced colorectal cancer or distant metastasis at baseline;
  • History of other active malignancies;
  • Patients with inflammatory bowel disease, familial adenomatous polyposis, or other hereditary colorectal cancer syndromes;
  • Patients who received neoadjuvant therapy before endoscopic resection;
  • Incomplete pathological data or missing key variables;
  • Loss to follow-up or follow-up duration less than 6 months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Additional Surgery
Patients who underwent additional surgical resection following non-curative endoscopic resection based on pathological risk factors and clinical decision-making.
Procedure: Additional Surgery
Additional surgical resection performed after non-curative endoscopic resection based on pathological risk factors and clinical indications.
Surveillance
Patients managed with surveillance after non-curative endoscopic resection, including regular endoscopic and imaging follow-up without additional surgical intervention.
Other: Surveillance
Active surveillance with regular endoscopic and imaging follow-up without additional surgical intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Recurrence-Free Survival
Time Frame: Up to 2 years
Up to 2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Association Between High-Risk Pathological Factors and Recurrence
Time Frame: Up to 2 years
Up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanfang Hospital, Southern Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 3, 2025

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

April 14, 2026

First Submitted That Met QC Criteria

April 14, 2026

First Posted (Actual)

April 21, 2026

Study Record Updates

Last Update Posted (Actual)

April 21, 2026

Last Update Submitted That Met QC Criteria

April 14, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NFEC-2025-405

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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