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

Recruiting

• Conditions: Gastric Cancer; ctDNA

• Registration Number: NCT05029869
• Lead Sponsor: University Medical Center Ho Chi Minh City (UMC)

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

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 Timeline

• Study First Submitted: 2021-08-25
• Study First Submitted QC: 2021-08-25
• Study First Posted: 2021-09-01
• Study Start: 2021-10-04
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-27
• Last Update Posted: 2022-04-28
• Primary Completion: 2023-09-30
• Study Completion: 2024-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The specificity of MRD detection using ctDNA as the biomarker	2 years after surgery	The percentage of positive ctDNA detection among participants who do not experience disease recurrence or metastasis
The sensitivity of MRD detection using ctDNA as the biomarker	2 years after surgery	The percentage of positive ctDNA detection among participants who experience disease recurrence or metastasis

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Medical Center Ho Chi Minh City; 🇻🇳 Ho Chi Minh City, Vietnam