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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05029869
Other study ID # 81/GCN-HDDD 2021
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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