- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06958926
- Original Trial
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
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Yu-Tso Liao, MD, PhD
- Phone Number: 1971 886-3667-7600
- Email: G02386@hch.gov.tw
Study Locations
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-
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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
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
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
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)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 202407175RINC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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