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Recruiting NCT06958926

A Translational Study for Locoregional Recurrence of T4 Colon Cancer

Observational T4 Colorectal Cancer Colorectal Cancer Stage III Colorectal Cancer Stage II

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Radical surgery for colon and rectum cancer, Radical surgery for colorectal cancer.
Who it may be relevant to
Registry conditions: T4 Colorectal Cancer, Colorectal Cancer Stage III, Colorectal Cancer Stage II. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

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

Primary outcome measures

  • The correlation the cell-free DNA level and sequencing between ascites and serum [Time frame: One year]

Eligibility criteria

  • Inclusion Criteria:
  • Age ≥ 18 years old
  • Diagnosed as colorectal cancer
  • Undergo radical colectomy or palliative colectomy, not limited to minimally invasive surgery or open surgery
  • Exclusion Criteria:
  • Age<18 years old
  • Pregnancy
  • Patients with peritoneal dialysis
  • Patients who are unwilling to undergo colorectal surgery

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Taiwan · 1 center
  • National Taiwan University Hospital Hsin-Chu branch — Hsinchu

Identifiers

NCT: NCT06958926 · 202407175RINC

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗