Detection of Plasma Circulating Tumor DNA in Gastric Cancer

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.

Study Overview

• Status: Recruiting
• Conditions: Gastric Cancer; Circulating Tumor DNA (ctDNA)
• Intervention / Treatment: Diagnostic test: plasma circulating tumor DNA

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 Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• Vietnam
  • Ho Chi Minh City, Vietnam, 700000
    • Recruiting
    • University Medical Center Ho Chi Minh city
    • Contact: Long D. Vo, MD.; Phone Number: +84.918133915; Email: long.vd@umc.edu.vn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with early and locally advanced stage (I, II and IIIA) gastric cancer

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
100 healthy people; 10 ml blood and tissue biopsy were collected from each patient	Diagnostic test: plasma circulating tumor DNA; A liquid biopsy assay for identification of tumor derived mutations in plasma of gastric cancer
100 gastric cancer patients; 10 ml blood and tissue biopsy were collected from each patient	Diagnostic test: plasma circulating tumor DNA; A liquid biopsy assay for identification of tumor derived mutations in plasma of gastric cancer

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Medical Center Ho Chi Minh City (UMC)

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2021
• Primary Completion (Anticipated): September 30, 2023
• Study Completion (Anticipated): September 30, 2023

Study Registration Dates

• First Submitted: August 25, 2021
• First Submitted That Met QC Criteria: August 25, 2021
• First Posted (Actual): August 30, 2021

Study Record Updates

• Last Update Posted (Actual): April 28, 2022
• Last Update Submitted That Met QC Criteria: April 27, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms
• Other Study ID Numbers: 79/GCN-HDDD 2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No