Detection of Plasma Circulating Tumor DNA in Gastric Cancer

Gastric Cancer Clinical Trial

Official title:

Detection of Plasma Circulating Tumor DNA in Gastric Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05027347
• Other study ID #: 79/GCN-HDDD 2021
• Status: Recruiting
• Start date: October 10, 2021
• Est. completion date: September 30, 2023

Study information

• Verified date: April 2022
• Source: University Medical Center Ho Chi Minh City (UMC)
• Contact: Long D. Vo, MD.
• Phone: +84918133915
• Email: long.vd[@]umc.edu.vn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: September 30, 2023
• 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 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

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Diagnostic Test:
• plasma circulating tumor DNA
A liquid biopsy assay for identification of tumor derived mutations in plasma of gastric cancer

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 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	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
Secondary	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