Detection of Plasma Circulating Tumor DNA in Gastric Cancer

• Conditions: Gastric Cancer; Circulating Tumor DNA (ctDNA)
• Interventions: Diagnostic Test: plasma circulating tumor DNA

• Registration Number: NCT05027347
• Lead Sponsor: University Medical Center Ho Chi Minh City (UMC)

Brief Summary

The aim of this study is to develop a protocol for detection of circulating tumor DNA (ctDNA) in plasma of patients with early stages of gastric cancer.

Detailed Description

Gastric cancer (GC) is the fifth most common cancer worldwide and the third leading cause of cancer deaths. Earlier detection of GC can dramatically increases the five-year survival rate up to \> 90%. The current endoscopy and tissue biopsy remain excessively expensive for middle-income nations, in addition to being fairly invasive, with possible complications. Additionally, most of serum-based biomarkers such as carcinoembryonic antigen (CEA), carbohydrate antigen 19-9 (CA19-9), carbohydrate antigen 72-4 (CA72-4), and carbohydrate antigen 125 (CA125) are not recommended for detection of GC due to the limit of specificity and sensitivity in the early stages of GC. Thus, it is essential to identify new biomarkers for diagnosis of early stages of GC. In this study, the investigators develop an ultradeep massive parallel sequencing (MPS) assay to detect tumor derived mutations (TDM) in plasma of early stages of GC. This study provides proof-of-principle for eventual clinical employment of circulating DNA, via liquid biopsy, for detection of early stages of GC.

Study Timeline

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

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. Male or Female patients aged 18 years and older
2. Histologically proven stage (I, II and IIIA) gastric adenocarcinoma
3. Naivety to treatment.
4. No known other concomitant cancer diagnosis
5. Signed informed consent

Exclusion Criteria

1. Pathologically late stage (stage IIIB and IV) or metastatic gastric adenocarcinoma
2. Underwent any type of treatment
3. Unable to undergo biopsy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
100 gastric cancer patients	plasma circulating tumor DNA	10 ml blood and tissue biopsy were collected from each patient
100 healthy people	plasma circulating tumor DNA	10 ml blood and tissue biopsy were collected from each patient

Primary Outcome Measures

Name	Time	Method
The sensitivity and and specificity of our mutation-based assay for detecting early-stage gastric cancer patients	1 months after collecting blood and specimen	sensitivity and and specificity of our mutation-based assay for detecting early-stage gastric cancer patients

Secondary Outcome Measures

Name	Time	Method
Limit of detection (LOD): the lowest variant allelic frequency that can be reliably detected	1 months after collecting blood and specimen	the lowest variant allelic frequency that can be reliably detected
The concordance rate of mutation results between plasma and tissue biopsy assay	1 months after collecting blood and specimen	The concordance rate of mutation results between plasma and tissue biopsy

Trial Locations

Locations (1)

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