NCT05498194

Brief Summary

This study is to develop methods for identification of neoantigens from patients with gastric cancer.

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
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2022

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

August 9, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 11, 2022

Completed
4 days until next milestone

Study Start

First participant enrolled

August 15, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

August 11, 2022

Status Verified

August 1, 2022

Enrollment Period

1.4 years

First QC Date

August 9, 2022

Last Update Submit

August 9, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • The neoantigen landscape of patients with gastric cancer

    The analysis of tumor DNA and RNA sequencing data will provide the mutational distribution of patients with gastric cancer, which could give rise to neoantigens. Of those, neoantigens derived from hotspot mutations in Vietnamese gastric cancer patients will be identified.

    3 months from the beginning of the study

Secondary Outcomes (2)

  • The ratio of predicted neoantigens being presented by HLA-I

    6 months from the beginning of the study

  • The ratio of predicted neoantigens being immunogenic.

    12 months from the beginning of the study

Interventions

10 ml of whole blood is collected from each patient prior surgery Fresh tumor tissue samples (\~ 1cm3 ) are collected during surgery

Eligibility Criteria

Age15 Years - 18 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

All the patients who were diagnosed with adavanced gastric cancer and underwent surgical resection

You may qualify if:

  • Male or Female patients aged 15 years and older
  • Diagnosed with advanced gastric cancer (T2-4b/N0-3/M0-1 stage, according to the eighth edition of the American Joint Committee on Cancer TNM (AJCC TNM) system)
  • Treatment-Naive
  • Not known for other concomitant cancers
  • Provide written informed consent

You may not qualify if:

  • Insufficient tumor tissues (less than 1 cm3)
  • Unable to sign informed consent
  • Underwent treatment

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

Location

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

August 9, 2022

First Posted

August 11, 2022

Study Start

August 15, 2022

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

August 11, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations