Genomic Evolution of Metastasis in Gastric Cancer

Sponsor
University Medical Center Ho Chi Minh City (UMC) (Other)
Overall Status
Recruiting
CT.gov ID
NCT05061082
Collaborator
(none)
20
1
12.2
1.6

Study Details

Study Description

Brief Summary

The aim of this study is to track tumor evolution of regional and distant metastases in gastric cancer using the Next Generation Sequencing technologies.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Gastric cancer is the fourth most common cancer in Vietnam with high mortality rate. Metastasis is the leading cause of death in gastric cancer patients, with median overall survival of less than 1 year. Currently, there is no effective treatment because the molecular mechanism of metastasis remains unclear. The aim of this study is to use advanced NGS technologies to dissect the genomic changes (genetic, epigenetic and transcriptional changes) of the primary tumor and associated metastatic sites of the same patients. With that, the investigators can reconstruct the clonal evolution from primary tumor to metastasis, identify key pathways governing metastasis development that can be targeted for future therapeutic development.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    20 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Genomic Evolution of Metastasis in Gastric Cancer
    Actual Study Start Date :
    Oct 26, 2021
    Anticipated Primary Completion Date :
    Oct 31, 2022
    Anticipated Study Completion Date :
    Oct 31, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Genetic and epigenetic changes of the tumor [3 months after surgery]

      Ultra-deep NGS of the primary tumor and associated metastatic sites from the same patients to identify mechanism governing metastasis development

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    1. Male or Female patients aged 18 years and older

    2. Histologically proven primary gastric adenocarcinoma and clinical evidence of metastasis (N1-3M1)

    3. Biopsies can be taken at multiple sites

    4. No known other concomitant cancer diagnosis

    5. Signed informed consent

    Exclusion Criteria:
    1. Gastric adnocarcinoma cannot be confirmed primary

    2. Unable to undergo biopsy or surgery

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Medical Center Ho Chi Minh City Ho Chi Minh City Vietnam 700000

    Sponsors and Collaborators

    • University Medical Center Ho Chi Minh City (UMC)

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Medical Center Ho Chi Minh City (UMC)
    ClinicalTrials.gov Identifier:
    NCT05061082
    Other Study ID Numbers:
    • 80/GCN-HDDD 2021
    First Posted:
    Sep 29, 2021
    Last Update Posted:
    Apr 28, 2022
    Last Verified:
    Apr 1, 2022
    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
    Keywords provided by University Medical Center Ho Chi Minh City (UMC)
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 28, 2022