NCT06023121

Brief Summary

Early-onset gastric cancer (EOGC) is a lethal malignancy with a poor prognosis. It differs from late-onset gastric cancer (LOGC) in clinical and molecular characteristics. The current strategies for EOGC detection have certain limitations in diagnostic performance due to the rising trend in EOGC. Hence, identifying novel EOGC bioindicators is crucial.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 1, 2018

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

August 29, 2023

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 5, 2023

Completed
Last Updated

September 5, 2023

Status Verified

August 1, 2023

Enrollment Period

5.6 years

First QC Date

August 29, 2023

Last Update Submit

August 29, 2023

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

  • Detection of levels of an exosome-based liquid biopsy signature

    A three exo-LR (NALT1, PTENP1, and HOTTIP) liquid biopsy signature was developed for EOGC detection.

    Through study completion, an average of 3 year

Study Arms (2)

Cases

Gastric cancer cases from two medical centers in China

Diagnostic Test: Measurement of levels of an exosome-based liquid biopsy signature

Controls

Controls from two medical centers in China

Diagnostic Test: Measurement of levels of an exosome-based liquid biopsy signature

Interventions

Measurement of levels of an exosome-based liquid biopsy signatureDIAGNOSTIC_TEST

Each participant was enrolled to assess the levels of an exosome-based liquid biopsy signature

CasesControls

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Community Sample Shanxi - Hospital and community sample Beijing -Hospital

You may qualify if:

  • Having signed informed consent
  • years old ≥ Age ≥ 18 years old
  • Histologically confirmed gastric adenocarcinoma

You may not qualify if:

  • Other previous malignancy within 5 year
  • Surgery (excluding diagnostic biopsy) within 4 weeks prior to study
  • Pregnancy or lactation period
  • Legal incapacity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinese PLA General Hospital Ethics Committee

Beijing, Beijing Municipality, 100853, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood sample

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of department of General Surgery

Study Record Dates

First Submitted

August 29, 2023

First Posted

September 5, 2023

Study Start

January 1, 2018

Primary Completion

August 1, 2023

Study Completion

August 30, 2023

Last Updated

September 5, 2023

Record last verified: 2023-08

Locations

CN(1)