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NCT Number: NCT05029869

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

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

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This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Medical Center Ho Chi Minh City

Ho Chi Minh City, 700000, Vietnam

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

ctDNA

Diagnostic Test

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

Primary outcomes

  1. The sensitivity of MRD detection using ctDNA as the biomarker

    Time frame: 2 years after surgery

    The percentage of positive ctDNA detection among participants who experience disease recurrence or metastasis

  2. The specificity of MRD detection using ctDNA as the biomarker

    Time frame: 2 years after surgery

    The percentage of positive ctDNA detection among participants who do not experience disease recurrence or metastasis

Secondary outcomes

  1. Leading time between ctDNA detection and cancer recurrence detected by conventional methods

    Time frame: 2 years after surgery

    Time is measured between first positive ctDNA detection and first cancer recurrence detected by conventional methods

  2. Mean ctDNA level (MTM/ml) of gastric cancer before operation

    Time frame: Within 14 days before operation

    The mean ctDNA level in gastric cancer patients before operation

  3. Mutation profile of gastric cancer

    Time frame: Within 14 days before operation

    Profiling of the most frequent gene mutations

Sponsors and collaborators

Lead sponsor

University Medical Center Ho Chi Minh City (UMC)

Other

Registry information

Official study title

Monitoring Minimal Residual Disease in Gastric Cancer by Liquid Biopsy

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Sep 1, 2021
Registry last updated
Aug 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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