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NCT Number: NCT06958926

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

National Taiwan University Hospital Hsin-Chu branch

Hsinchu, 308, Taiwan

Location status: Recruiting

Location contact

Yu-Tso Liao, MD, PhD

CONTACT

[email protected]

+886972654554

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: One year

Study contacts

Contact information is provided by the study sponsor or research team.

Yu-Tso Liao, MD, PhD

CONTACT

[email protected]

886-3667-7600 ext. 1971

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2028
First posted
May 6, 2025
Registry last updated
May 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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