A Translational Study for Locoregional Recurrence of T4 Colon Cancer

May 21, 2025 updated by: National Taiwan University Hospital

The outcome of T4 locally advanced colon cancer is poor when locoregional recurrence occurred. Previous studies had showed that the aggravation of T4 colon cancer is higher than N-positive colon cancer, contributing to staging paradox that outcomes of stage IIB/C are poorer than stage IIIA colon cancer and higher locoregional recurrence of stage IIB/C colon cancer. The phenomenon cannot be explained by radicality, lymph node harvested and adjuvant chemotherapy administration. To elucidate the cancerous aggravation of T4 colon cancer, the investigators should dive into the clinicopathology, metastatic mechanism and cancer biology.

The investigators hypothesize that peritoneal spreading can be one of the metastatic routes of T4 colon cancer; however, few studies have addressed the finding and deserved investigation. Previous research have found that serum epigenetic alterations and cell-free DNA can serve as a prognostic marker for stage II/III colon cancer.

Therefore, the aim of this study is (1) to explore the role of ascites cfDNA as a potential biomolecular marker for locoregional recurrence; (2) to identify the risk factors of locoregional recurrence for T4 colon cancer by correlating biomolecular markers between clinicopathology, epigenomic alterations in blood and ascites.

Study Overview

Study Type

Observational

Enrollment (Estimated)

60

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

  • Name: Yu-Tso Liao, MD, PhD
  • Phone Number: 1971 886-3667-7600
  • Email: G02386@hch.gov.tw

Study Locations

      • Hsinchu, Taiwan, 308
        • Recruiting
        • National Taiwan University Hospital Hsin-Chu Branch
        • Contact:

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

Patients with suspected cT4 or pT4 colorectal cancer

Description

  • Inclusion Criteria:

    1. Age ≥ 18 years old
    2. Diagnosed as colorectal cancer
    3. Undergo radical colectomy or palliative colectomy, not limited to minimally invasive surgery or open surgery
  • Exclusion Criteria:

    1. Age<18 years old
    2. Pregnancy
    3. Patients with peritoneal dialysis
    4. Patients who are unwilling to undergo colorectal 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The correlation the cell-free DNA level and sequencing between ascites and serum
Time Frame: One year
One year

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Yu-Tso Liao, MD, PhD, National Taiwan University Hospital Hsin-Chu Branch
  • Principal Investigator: Yu-Tso Liao, National Taiwan University Hospital Hsin-Chu Branch

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)

May 14, 2025

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

April 14, 2025

First Submitted That Met QC Criteria

April 27, 2025

First Posted (Actual)

May 6, 2025

Study Record Updates

Last Update Posted (Actual)

May 25, 2025

Last Update Submitted That Met QC Criteria

May 21, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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.

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