Predicting Local and Distant Recurrence in T1 Colorectal Cancer (T1CR)

March 15, 2024 updated by: City of Hope Medical Center

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Japan
      • Tokushima, Japan
        • Recruiting
        • Tokushima University
        • Contact:
        • Sub-Investigator:
          • Katsuki Miyazaki
        • Sub-Investigator:
          • Takayuki Noma, MD
        • Sub-Investigator:
          • Yuma Wada, PhD
        • Principal Investigator:
          • Mistuo Shimada, PhD
  • Spain
      • Barcelona, Spain
        • Recruiting
        • Barcelona University
        • Principal Investigator:
          • Maria Pellise
        • Contact:
        • Sub-Investigator:
          • Karmele Saez de Gordoa
        • Sub-Investigator:
          • María Daca
        • Principal Investigator:
          • Francesc Balaguer
  • United States
    • California
      • Duarte, California, United States, 91010
        • Recruiting
        • City of Hope Medical Center
        • Contact:
        • Principal Investigator:
          • Ajay Goel, PhD
        • Principal Investigator:
          • Takayuki Noma, MD
        • Sub-Investigator:
          • Alessandro Mannucci

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Two cohorts of patients with T1 colorectal cancer

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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)
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
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)
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
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)
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
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence-free Survival
Time Frame: Up to 60 months
Time from curative-intent resection to the development of recurrence (or death)
Up to 60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

City of Hope Medical Center

Investigators

  • Principal Investigator: Ajay Goel, PhD, City of Hope Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2023

Primary Completion (Estimated)

March 15, 2025

Study Completion (Estimated)

March 15, 2025

Study Registration Dates

First Submitted

March 11, 2024

First Submitted That Met QC Criteria

March 15, 2024

First Posted (Actual)

March 18, 2024

Study Record Updates

Last Update Posted (Actual)

March 18, 2024

Last Update Submitted That Met QC Criteria

March 15, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23228/T1CR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Data collected for the study will be made available to others, including de-identified participant data, at publication, via a signed data access agreement and at the discretion of the investigators' approval of the proposed use of such data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Colorectal Neoplasms

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mongolia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe