Circulating Tumor DNA (ctDNA), Gastric Cancer
Conditions
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.
Interventions
DIAGNOSTIC_TESTplasma circulating tumor DNA
A liquid biopsy assay for identification of tumor derived mutations in plasma of gastric cancer
Sponsors
University Medical Center Ho Chi Minh City (UMC)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Countries
Vietnam
Contacts
Primary ContactLong D. Vo, MD.
Outcome results
None listed