A Translational Study for Locoregional Recurrence of T4 Colon Cancer

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

• Status: Recruiting
• Conditions: Colorectal Cancer Stage II; Colorectal Cancer Stage III; T4 Colorectal Cancer
• Intervention / Treatment: Procedure: Radical surgery for colon and rectum cancer; Procedure: Radical surgery for colorectal cancer

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

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

Study Locations

• Taiwan
  • Hsinchu, Taiwan, 308
    • Recruiting
    • National Taiwan University Hospital Hsin-Chu Branch
    • Contact: Yu-Tso Liao, MD, PhD; Phone Number: +886972654554; Email: G02386@hch.gov.tw

Participation Criteria

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

How is the study designed?

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	One year

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• 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

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

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Site; Neoplasms; Disease Attributes; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Recurrence; Colorectal Neoplasms
• Other Study ID Numbers: 202407175RINC

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