Detection of Plasma Circulating Tumor DNA in Gastric Cancer
1 other identifier
observational
200
1 country
1
Brief Summary
The aim of this study is to develop a protocol for detection of circulating tumor DNA (ctDNA) in plasma of patients with early stages of gastric cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 25, 2021
CompletedFirst Posted
Study publicly available on registry
August 30, 2021
CompletedStudy Start
First participant enrolled
October 10, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2023
CompletedApril 28, 2022
April 1, 2022
2 years
August 25, 2021
April 27, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
The sensitivity and and specificity of our mutation-based assay for detecting early-stage gastric cancer patients
sensitivity and and specificity of our mutation-based assay for detecting early-stage gastric cancer patients
1 months after collecting blood and specimen
Secondary Outcomes (2)
Limit of detection (LOD): the lowest variant allelic frequency that can be reliably detected
1 months after collecting blood and specimen
The concordance rate of mutation results between plasma and tissue biopsy assay
1 months after collecting blood and specimen
Study Arms (2)
100 healthy people
10 ml blood and tissue biopsy were collected from each patient
100 gastric cancer patients
10 ml blood and tissue biopsy were collected from each patient
Interventions
A liquid biopsy assay for identification of tumor derived mutations in plasma of gastric cancer
Eligibility Criteria
Patients diagnosed with early and locally advanced stage (I, II and IIIA) gastric cancer
You may qualify if:
- Male or Female patients aged 18 years and older
- Histologically proven stage (I, II and IIIA) gastric adenocarcinoma
- Naivety to treatment.
- No known other concomitant cancer diagnosis
- Signed informed consent
You may not qualify if:
- Pathologically late stage (stage IIIB and IV) or metastatic gastric adenocarcinoma
- Underwent any type of treatment
- Unable to undergo biopsy
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
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 25, 2021
First Posted
August 30, 2021
Study Start
October 10, 2021
Primary Completion
September 30, 2023
Study Completion
September 30, 2023
Last Updated
April 28, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will not share