A Translational Study for Locoregional Recurrence of T4 Colon Cancer

NCT06958926 | Recruiting

• 1 other identifier: 202407175RINC
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

T4 Colorectal Cancer; Colorectal Cancer Stage III; Colorectal Cancer Stage II

Outcome Measures

Primary Outcomes (1)

• The correlation the cell-free DNA level and sequencing between ascites and serum

  One year

Interventions

Radical surgery for colon and rectum cancer PROCEDURE

Radical surgery for colon and rectum cancer indicates that the surgery intends to eradicate all identifiable tumor in the human body.

Radical surgery for colorectal cancer PROCEDURE

Radical surgery for colorectal cancer indicates that the surgery intends to eradicate all identifiable tumor in the human body.

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

Patients with suspected cT4 or pT4 colorectal cancer

You may qualify if:

• Age ≥ 18 years old
• Diagnosed as colorectal cancer
• Undergo radical colectomy or palliative colectomy, not limited to minimally invasive surgery or open surgery

You may not qualify if:

• Age\<18 years old
• Pregnancy
• Patients with peritoneal dialysis
• Patients who are unwilling to undergo colorectal surgery

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital Hsin-Chu branch

Hsinchu, 308, Taiwan

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

ascites cell-free DNA, serum cell-free DNA

MeSH Terms

Conditions

Colorectal 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

• Yu-Tso Liao, MD, PhD

  National Taiwan University Hospital Hsin-Chu Branch

  PRINCIPAL INVESTIGATOR

• Yu-Tso Liao

  National Taiwan University Hospital Hsin-Chu Branch

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yu-Tso Liao, MD, PhD

CONTACT

886-3667-7600; G02386@hch.gov.tw

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2025
• First Posted: May 6, 2025
• Study Start: May 14, 2025
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 25, 2025

Record last verified: 2025-04

Locations

TW (1)