MedPath

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.

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
NameTimeMethod
Recurrence-free SurvivalUp to 60 months

Time from curative-intent resection to the development of recurrence (or death)

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (3)

City of Hope Medical Center

🇺🇸

Duarte, California, United States

Tokushima University

🇯🇵

Tokushima, Japan

Barcelona University

🇪🇸

Barcelona, Spain

City of Hope Medical Center
🇺🇸Duarte, California, United States
Ajay Goel, PhD
Principal Investigator
Takayuki Noma, MD
Principal Investigator
Alessandro Mannucci
Sub Investigator

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