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Completed

NCT Number: NCT06314971

Predicting Local and Distant Recurrence in T1 Colorectal Cancer

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

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)

Other names: T1 Colorectal cancer rEcurrence (Tw1CE)

Primary outcomes

  1. Recurrence-free Survival

    Time frame: Up to 60 months

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

Sponsors and collaborators

Lead sponsor

City of Hope Medical Center

Other

Registry information

Official study title

Predicting Recurrence After Curative-Intent Resection of T1 Colorectal Cancer With Transcriptomics

Acronym: T1CR

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Mar 18, 2024
Registry last updated
Jul 3, 2025

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.

Published trials that share one or more normalized conditions with this study.