Predicting Local and Distant Recurrence in T1 Colorectal Cancer

NCT06314971 | Completed

• 1 other identifier: 23228/T1CR
• Study Type: observational
• Target: 138
• Locations: 3 countries
• Sites: 3

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.

Conditions

Colorectal Cancer; Colorectal Neoplasms; Colorectal Adenocarcinoma; Colorectal Cancer Stage I; Colorectal Neoplasms Malignant; Colorectal Cancer Recurrent

Keywords

Endoscopic Submucosal Dissection (ESD); Endoscopic Submucosal Resection; Surgery; T1; Pathological T1 (pT1); Messenger RNA; Micro RNA; Formalin-Fixed Paraffin Embedded; Tissue; Transcriptomics

Outcome Measures

Primary Outcomes (1)

• Recurrence-free Survival

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

  Up to 60 months

Study Arms (4)

T1 Colorectal Cancer, With Recurrence (Training)

Survivors of T1 colorectal cancer who developed recurrent colorectal cancer within 36 months from primary tumor treatment, in the first cohort

Other: Tw1CE

T1 Colorectal Cancer, Without Recurrence (Training)

Survivors of T1 colorectal cancer who did not develop recurrent colorectal cancer within 36 months from primary tumor treatment, in the first cohort

Other: Tw1CE

T1 Colorectal Cancer, With Recurrence (Validation)

Survivors of T1 colorectal cancer who developed recurrent colorectal cancer within 36 months from primary tumor treatment, in the second cohort

Other: Tw1CE

T1 Colorectal Cancer, Without Recurrence (Validation)

Survivors of T1 colorectal cancer who did not develop recurrent colorectal cancer within 36 months from primary tumor treatment, in the second cohort

Other: Tw1CE

Interventions

Tw1CE OTHER

A panel of microRNA and messenger RNA, whose expression level is tested in macro-dissected formalin-fixed and paraffin-embedded (FFPE) samples derived from the primary tumor, with reverse transcriptase quantitative polymerase chain reaction (RT-qPCR)

Also known as: T1 Colorectal cancer rEcurrence (Tw1CE)

T1 Colorectal Cancer, With Recurrence (Training); T1 Colorectal Cancer, With Recurrence (Validation); T1 Colorectal Cancer, Without Recurrence (Training); T1 Colorectal Cancer, Without Recurrence (Validation)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Two cohorts of patients with T1 colorectal cancer

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• City of Hope Medical Center: lead

Study Sites (3)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

Tokushima University

Tokushima, Japan

Location

Barcelona University

Barcelona, Spain

Location

Related Publications (29)

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• Noma T, Saez de Gordoa K, Daca-Alvarez M, Miyazaki K, Wada Y, Mannucci A, Onoyama T, Shimada M, Cuatrecasas M, Bujanda L, Pellise M, Goel A; part of the EpiT1 Consortium. A machine learning-based transcriptomic signature for predicting tumor recurrence after curative resection in T1 colorectal cancer: a retrospective multicenter cohort study (The Tw1CE trial). Int J Surg. 2026 Jan 28. doi: 10.1097/JS9.0000000000004690. Online ahead of print.

  PMID: 41604539 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Formalin-fixed, paraffin-embedded slide from the primary tumor

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Ajay Goel, PhD

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2024
• First Posted: March 18, 2024
• Study Start: March 15, 2023
• Primary Completion: June 15, 2025
• Study Completion: June 30, 2025
• Last Updated: July 3, 2025

Record last verified: 2025-07

Locations

ES (1); US (1); JP (1)