Predicting Local and Distant Recurrence in T1 Colorectal Cancer

Last updated: July 1, 2025
Sponsor: City of Hope Medical Center
Overall Status: Completed

Phase

N/A

Condition

Colorectal Cancer

Colon Cancer; Rectal Cancer

Colon Cancer

Treatment

Tw1CE

Clinical Study ID

NCT06314971
23228/T1CR
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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

Total Participants: 138
Treatment Group(s): 1
Primary Treatment: Tw1CE
Phase:
Study Start date:
March 15, 2023
Estimated Completion Date:
June 30, 2025

Study 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.

Connect with a study center

  • Tokushima University

    Tokushima,
    Japan

    Site Not Available

  • Barcelona University

    Barcelona,
    Spain

    Site Not Available

  • City of Hope Medical Center

    Duarte, California 91010
    United States

    Site Not Available

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