NCT05061082

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 9, 2021

Completed
20 days until next milestone

First Posted

Study publicly available on registry

September 29, 2021

Completed
27 days until next milestone

Study Start

First participant enrolled

October 26, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2022

Completed
Last Updated

April 28, 2022

Status Verified

April 1, 2022

Enrollment Period

1 year

First QC Date

September 9, 2021

Last Update Submit

April 27, 2022

Conditions

Keywords

Gastric CancerMetastasis

Outcome Measures

Primary Outcomes (1)

  • Genetic and epigenetic changes of the tumor

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

    3 months after surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with metastatic gastric adenocarcinoma

You may qualify if:

  • Male or Female patients aged 18 years and older
  • Histologically proven primary gastric adenocarcinoma and clinical evidence of metastasis (N1-3M1)
  • Biopsies can be taken at multiple sites
  • No known other concomitant cancer diagnosis
  • Signed informed consent

You may not qualify if:

  • Gastric adnocarcinoma cannot be confirmed primary
  • Unable to undergo biopsy or surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Ho Chi Minh City

Ho Chi Minh City, 700000, Vietnam

RECRUITING

MeSH Terms

Conditions

Stomach NeoplasmsNeoplasm Metastasis

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Long Duy Vo, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2021

First Posted

September 29, 2021

Study Start

October 26, 2021

Primary Completion

October 31, 2022

Study Completion

October 31, 2022

Last Updated

April 28, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations