Detection of Plasma Circulating Tumor DNA in Gastric Cancer

NCT ID: NCT05027347

Last Updated: 2022-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-10

Study Completion Date

2023-09-30

Brief Summary

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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

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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.

Conditions

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Circulating Tumor DNA (ctDNA) Gastric Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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100 healthy people

10 ml blood and tissue biopsy were collected from each patient

plasma circulating tumor DNA

Intervention Type DIAGNOSTIC_TEST

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

plasma circulating tumor DNA

Intervention Type DIAGNOSTIC_TEST

A liquid biopsy assay for identification of tumor derived mutations in plasma of gastric cancer

Interventions

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plasma circulating tumor DNA

A liquid biopsy assay for identification of tumor derived mutations in plasma of gastric cancer

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Medical Center Ho Chi Minh City (UMC)

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University Medical Center Ho Chi Minh City

Ho Chi Minh City, , Vietnam

Site Status RECRUITING

Countries

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Vietnam

Central Contacts

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Long D. Vo, MD.

Role: CONTACT

+84918133915

Facility Contacts

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Long D. Vo, MD.

Role: primary

+84.918133915

Other Identifiers

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79/GCN-HDDD 2021

Identifier Type: -

Identifier Source: org_study_id

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