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

Gastric Cancer Clinical Trial

Official title:

Monitoring Minimal Residual Disease in Gastric Cancer by Liquid Biopsy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05029869
• Other study ID #: 81/GCN-HDDD 2021
• Status: Recruiting
• Start date: October 4, 2021
• Est. completion date: October 1, 2024

Study information

• Verified date: April 2022
• Source: University Medical Center Ho Chi Minh City (UMC)
• Contact: Long D. Vo
• Phone: +84.918133915
• Email: long.vd[@]umc.edu.vn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 1, 2024
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• ctDNA
• Gastric Cancer
• Neoplasm, Residual
• Stomach Neoplasms

Intervention

Diagnostic Test:
• 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

Locations

Country	Name	City	State
Vietnam	University Medical Center Ho Chi Minh City	Ho Chi Minh City

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Ho Chi Minh City (UMC)

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	Mutation profile of gastric cancer	Profiling of the most frequent gene mutations	Within 14 days before operation