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NCT Number: NCT07542171

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, China

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Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Additional Surgery

Procedure

Additional surgical resection performed after non-curative endoscopic resection based on pathological risk factors and clinical indications.

Surveillance

Other

Active surveillance with regular endoscopic and imaging follow-up without additional surgical intervention.

Primary outcomes

  1. Recurrence-Free Survival

    Time frame: Up to 2 years

Secondary outcomes

  1. Association Between High-Risk Pathological Factors and Recurrence

    Time frame: Up to 2 years

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Nanfang Hospital, Southern Medical University

Other

Registry information

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Apr 21, 2026
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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