Monitoring Minimal Residual Disease in Gastric Cancer by Liquid Biopsy Study Description
1 other identifier
observational
100
1 country
1
Brief Summary
This study aims to evaluate the use of Next Generation Sequencing (NGS) to detect circulating tumor DNA in gastric cancer patients after gastrectomy
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2021
Longer than P75 for all trials
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
September 1, 2021
CompletedStudy Start
First participant enrolled
October 4, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 30, 2026
August 13, 2025
June 1, 2025
5.2 years
August 25, 2021
August 8, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
The sensitivity of MRD detection using ctDNA as the biomarker
The percentage of positive ctDNA detection among participants who experience disease recurrence or metastasis
2 years after surgery
The specificity of MRD detection using ctDNA as the biomarker
The percentage of positive ctDNA detection among participants who do not experience disease recurrence or metastasis
2 years after surgery
Secondary Outcomes (3)
Leading time between ctDNA detection and cancer recurrence detected by conventional methods
2 years after surgery
Mean ctDNA level (MTM/ml) of gastric cancer before operation
Within 14 days before operation
Mutation profile of gastric cancer
Within 14 days before operation
Interventions
The blood samples for ctDNA and other tumor markers will be first collected within 14 days before surgery, and then be tested after gastrectomy in scheduled interval
Eligibility Criteria
Patients with newly diagnosed and untreated gastric adenocarcinoma
You may qualify if:
- Male or Female patients aged 18 years and older
- Histologically proven primary gastric adenocarcinoma before surgery
- Clinical stage is locally advanced cT2-4a any N and M0
- In initial evaluation, patient can undergo radical gastrectomy and lymphadenectomy
- No preoperative therapy, including chemotherapy and radiotherapy
- No known cancer diagnosis within last five years
- Signed informed consent
You may not qualify if:
- Gastrectomy cannot be achieved during operation due to metastasis
- Patient fails to follow-up and provide postoperative samples
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)
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
September 1, 2021
Study Start
October 4, 2021
Primary Completion (Estimated)
December 30, 2026
Study Completion (Estimated)
December 30, 2026
Last Updated
August 13, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share