Genomics and Prognosis in GI Cancers

Sponsor
National Health Research Institutes, Taiwan (Other)
Overall Status
Recruiting
CT.gov ID
NCT05767697
Collaborator
National Cheng-Kung University Hospital (Other)
1,000
2
68.5
500
7.3

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    In this study, we 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 Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    1000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Explore the Correlation of Genomics and Prognosis in Alimentary Tract Cancers
    Actual Study Start Date :
    Apr 15, 2020
    Anticipated Primary Completion Date :
    Dec 31, 2024
    Anticipated Study Completion Date :
    Dec 31, 2025

    Outcome Measures

    Primary Outcome Measures

    1. Number of subjects who still survive at 1 year [1 year]

      1 year overall survival rate

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Cheng-Kung University Hospital Tainan Taiwan
    2 National Institute of Cancer Research Tainan Taiwan

    Sponsors and Collaborators

    • National Health Research Institutes, Taiwan
    • National Cheng-Kung University Hospital

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Health Research Institutes, Taiwan
    ClinicalTrials.gov Identifier:
    NCT05767697
    Other Study ID Numbers:
    • A-ER-109-073
    First Posted:
    Mar 14, 2023
    Last Update Posted:
    Mar 14, 2023
    Last Verified:
    Feb 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 14, 2023