Monitoring Minimal Residual Disease in Gastric Cancer by Liquid Biopsy Study Description

Monitoring Minimal Residual Disease in Gastric Cancer by Liquid Biopsy

This study aims to evaluate the use of Next Generation Sequencing (NGS) to detect circulating tumor DNA in gastric cancer patients after gastrectomy

Study Overview

• Status: Active, not recruiting
• Conditions: Gastric Cancer; ctDNA
• Intervention / Treatment: Diagnostic test: ctDNA

Detailed Description

Gastric cancer is the fourth most common cancer in Vietnam with high mortality rate. Patients at early stages undergo radical gastrectomy with curative intent, but the remaining tumor cells, termed as minimal residual disease (MRD), can later cause relapse. Conventional methods to monitor MRD such as imaging and blood tests for biomarkers such as CEA are not sensitive and specific enough. ctDNA has recently emerged as a promising noninvasive marker with high accuracy to monitor MRD and detect relapse in many cancers such as breast and colorectal cancers. However, its application in gastric cancer has not been extensively evaluated. Therefore, this study aims to use advanced NGS technologies to detect ctDNA in liquid biopsy as a biomarker to monitor MRD after radical gastrectomy.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

Study Locations

• Vietnam
  • Ho Chi Minh City, Vietnam, 700000
    • University Medical Center Ho Chi Minh City

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with newly diagnosed and untreated gastric adenocarcinoma

Description

Inclusion Criteria:

1. Male or Female patients aged 18 years and older
2. Histologically proven primary gastric adenocarcinoma before surgery
3. Clinical stage is locally advanced cT2-4a any N and M0
4. In initial evaluation, patient can undergo radical gastrectomy and lymphadenectomy
5. No preoperative therapy, including chemotherapy and radiotherapy
6. No known cancer diagnosis within last five years
7. Signed informed consent

Exclusion Criteria:

1. Gastrectomy cannot be achieved during operation due to metastasis
2. Patient fails to follow-up and provide postoperative samples

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Leading time between ctDNA detection and cancer recurrence detected by conventional methods	Time is measured between first positive ctDNA detection and first cancer recurrence detected by conventional methods	2 years after surgery
Mean ctDNA level (MTM/ml) of gastric cancer before operation	The mean ctDNA level in gastric cancer patients before operation	Within 14 days before operation
Mutation profile of gastric cancer	Profiling of the most frequent gene mutations	Within 14 days before operation

Collaborators and Investigators

• Sponsor: University Medical Center Ho Chi Minh City (UMC)

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2021
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: August 25, 2021
• First Submitted That Met QC Criteria: August 25, 2021
• First Posted (Actual): September 1, 2021

Study Record Updates

• Last Update Posted (Actual): August 13, 2025
• Last Update Submitted That Met QC Criteria: August 8, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Site; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Neoplastic Processes; Stomach Neoplasms; Neoplasm, Residual
• Other Study ID Numbers: 81/GCN-HDDD 2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No