Genomics and Prognosis in GI Cancers

March 25, 2024 updated by: National Health Research Institutes, Taiwan

Explore the Correlation of Genomics and Prognosis in Alimentary Tract Cancers

This study aims to collect biospecimens and explore the correlation of genomics and prognosis in alimentary tract cancers.

Study Overview

Status

Recruiting

Conditions

Detailed Description

In this study, the investigators will collect clinical specimens of alimentary tract cancers and perform DNA and RNA analysis to identify genetic alterations for the development of a comprehensive somatic mutation databases and investigate their potential correlation with clinical, radiological and pathological variables. The genomics study included but not limited to target gene panel sequencing, whole exome sequencing, whole genome sequencing, bulk RNA sequencing, single cell RNA sequencing and metagenomics.

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Yung-Yeh Su, MD
  • Phone Number: 65181 +886-6-7000123
  • Email: yysu@nhri.edu.tw

Study Locations

  • Taiwan
      • Tainan, Taiwan
        • Recruiting
        • National Cheng-Kung University Hospital
        • Principal Investigator:
          • Li-Tzong Chen, MD PhD
        • Contact:
      • Tainan, Taiwan
        • Recruiting
        • National Institute of Cancer Research
        • Contact:
        • Principal Investigator:
          • Li-Tzong Chen, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Histology proved pancreatic cancer, esophageal cancer, gastric cancer, hepatocellular carcinoma, cholangiocarcinoma, colorectal cancer

Description

Inclusion Criteria:

  • Able to sign the informed consent
  • Age >= 20
  • Histology proved pancreatic cancer, esophageal cancer, gastric cancer, hepatocellular carcinoma, cholangiocarcinoma, colorectal cancer
  • Agree to provide tumor/normal tissue including but not limited to surgical specimen, biopsy, cytology specimen, bile, urine or stool
  • Agree to receive blood sampling 20ml at first time and 10ml during each follow-up (total sampling amount no more than 30ml per month)

Exclusion Criteria:

  • Cannot cooperate with blood sampling

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of subjects who still survive at 1 year
Time Frame: 1 year
1 year overall survival rate
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Health Research Institutes, Taiwan

Collaborators

National Cheng-Kung University Hospital

Investigators

  • Principal Investigator: Li-Tzong Chen, MD PhD, National Health Research Institutes, Taiwan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2020

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

March 2, 2023

First Submitted That Met QC Criteria

March 2, 2023

First Posted (Actual)

March 14, 2023

Study Record Updates

Last Update Posted (Actual)

March 26, 2024

Last Update Submitted That Met QC Criteria

March 25, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A-ER-109-073

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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