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

NCT ID: NCT05029869

Last Updated: 2025-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-04

Study Completion Date

2026-12-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Gastric Cancer ctDNA

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ctDNA

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Medical Center Ho Chi Minh City (UMC)

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Medical Center Ho Chi Minh City

Ho Chi Minh City, , Vietnam

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Vietnam

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

81/GCN-HDDD 2021

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.