Predicting Local and Distant Recurrence in T1 Colorectal Cancer

Completed

• Conditions: Colorectal Neoplasms Malignant; Colorectal Cancer Recurrent; Colorectal Neoplasms; Colorectal Adenocarcinoma; Colorectal Cancer; Colorectal Cancer Stage I

• Registration Number: NCT06314971
• Lead Sponsor: City of Hope Medical Center

Brief Summary

Tumor recurrence significantly affects survival rates following the local resection of submucosal colorectal cancers (T1 CRC). Despite this, there are currently no reliable biomarkers established to predict recurrence in T1 CRC.

This study seeks to improve the prediction of recurrence-free survival in individuals who have survived T1 CRC.

Detailed Description

The incidence of invasive submucosal colorectal cancer (T1 CRC) is increasing, likely as a reflection of improved screening and endoscopy use. Current treatment options for T1 CRC focus on less invasive methods (i.e., endoscopic submucosal dissection), and treatment decisions are based on the risk of lymph node metastasis (LNM). Up to 70-80% of T1 CRC patients may undergo surgery, with adjuvant chemotherapy recommended only for those with LNM.

However, current clinical practice guidelines are considered to be overly aggressive and recommend the administration of aggressive treatment to many patients who may be cured with non-invasive therapy alone. This results in the overtreatment of many patients, especially those that are currently defined as 'high-risk' T1 CRC. Existing surveillance methods may not adequately predict the prognosis of T1 CRC, lacking established biomarkers for assessing disease-free survival.

This study seeks to validate tissue-based biomarkers (micro-RNA and messenger RNA) that are associated with tumor recurrence after curative resection. The identification of patients at high risk of recurrence may help in the selection of patients who truly benefit from additional oncologic surgery or adjuvant therapy. Previous research by this group has identified miRNA signatures for detecting postoperative tumor recurrence and metastasis in CRC, highlighting their potential as biomarkers for disease progression.

Study Timeline

• Study Start: 2023-03-15
• Study First Submitted: 2024-03-11
• Study First Submitted QC: 2024-03-15
• Study First Posted: 2024-03-18
• Primary Completion: 2025-06-15
• Study Completion: 2025-06-30
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-01
• Last Update Posted: 2025-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 138

Inclusion Criteria

• Stage I, pT1 colorectal cancer (TNM classification, 8th edition).
• Received standard diagnostic, staging, and stage-specific curative-intent resection (endoscopic or surgical, as per local guidelines).
• Confirmed cancer-free survivorship at the time of study inclusion.

Exclusion Criteria

• Lack of informed consent.
• Induction of neoadjuvant systemic therapy before colorectal cancer resection.
• Synchronous colorectal and non-colorectal cancer diagnosed at or before surgery.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Recurrence-free Survival	Up to 60 months	Time from curative-intent resection to the development of recurrence (or death)

Trial Locations

Locations (3)

City of Hope Medical Center; 🇺🇸 Duarte, California, United States

Tokushima University; 🇯🇵 Tokushima, Japan

Barcelona University; 🇪🇸 Barcelona, Spain