An observational study in Circulating Tumor DNA (ctDNA) and Gastric Cancer, sponsored by University Medical Center Ho Chi Minh City (UMC). Status unknown at 1 site in Vietnam. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-04-28.
Sponsored by University Medical Center Ho Chi Minh City (UMC) · Observational
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.
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.
2,914 studies on the registry are indexed under Stomach Neoplasms; 880 are open to participants now.
This study's planned enrollment of 200 is below the median of 281 across 684 observational studies indexed under Stomach Neoplasms.
Browse Stomach Neoplasms studies →University Medical Center Ho Chi Minh City (UMC) is the lead sponsor of 33 studies on the registry; 18 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients diagnosed with early and locally advanced stage (I, II and IIIA) gastric cancer
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Exclusion Criteria:
10 ml blood and tissue biopsy were collected from each patient
Diagnostic Test: plasma circulating tumor DNA
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
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
Time frame: 1 months after collecting blood and specimen
Limit of detection (LOD): the lowest variant allelic frequency that can be reliably detected
the lowest variant allelic frequency that can be reliably detected
Time frame: 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
Time frame: 1 months after collecting blood and specimen
Plan to share: No
No publications or documents are linked to this record.
Started Oct 2021 (actual). Primary completion is estimated for Sep 2023, 23 months after the start.
Of 274 non-industry observational studies under Stomach Neoplasms, half reached primary completion within 59 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 171. This study's planned 23 months is below that.
Counting every sponsor, half of 305 studies reached it within 56 months; a quarter within 30 and three quarters within 120.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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University Medical Center Ho Chi Minh City (UMC)