An observational study in Gastric Cancer, Gastric Adenocarcinoma and Gastric Cancer Stage, sponsored by City of Hope Medical Center. Completed at 3 sites in 2 countries. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-08.
Sponsored by City of Hope Medical Center · Observational
Gastric cancer continues to have a poor prognosis primarily due to the inability to detect it in its early stages. This study will develop and validate a blood assay to facilitate the non-invasive detection of gastric cancer.
Gastric cancer continues to have a poor prognosis primarily due to the inability to detect it in its early stages. Because conventional endoscopy is invasive and costly, gastric cancer is currently not considered to be screenable at a population level. However, if one could find less invasive and cheaper tools that accurately detect gastric cancer in its early stages, it could make a significant difference. Accurate biomarkers could help identify patients with gastric cancer before it becomes incurable.
This study aims to develop a non-invasive test to detect gastric cancer early. It consists of four phases:
In summary, this study aims to develop a highly accurate and cost-effective blood test for detecting gastric cancer early. Success could lead to significant improvements in clinical practice by catching cancer when it is most treatable. By combining different genetic markers (cell-free microRNA and exosomal microRNA) for accuracy, this study has the potential to reduce gastric cancer deaths and could lead to new screening methods in the future.
2,851 studies on the registry are indexed under Stomach Neoplasms; 864 are open to participants now.
This study's enrollment of 809 is above the median of 274 across 670 observational studies indexed under Stomach Neoplasms.
Browse Stomach Neoplasms studies →City of Hope Medical Center is the lead sponsor of 670 studies on the registry; 181 are open to participants now.
Of its 30 completed or terminated interventional studies of FDA-regulated products, 12 (40%) have results posted.
Counted across the registry records on this site, refreshed daily.
Two cohorts of individuals with and without gastric cancer (cases and controls, respectively)
Exclusion Criteria:
Individuals with a pathologically confirmed diagnosis of gastric cancer
Diagnostic Test: DESTINEX
Individuals without cancer at the time of blood sampling
Diagnostic Test: DESTINEX
Individuals with a pathologically confirmed diagnosis of gastric cancer
Diagnostic Test: DESTINEX
Individuals without cancer at the time of blood sampling
Diagnostic Test: DESTINEX
A panel of microRNA, whose expression level is tested in serum samples.
Also known as: DESTINEX (DEtection of STomach NEoplasia in circulating eXosomes)
Sensitivity
True positive rate: the probability of a positive test result, conditioned on the individual truly being positive
Time frame: Through study completion, an average of 1 year
Specificity
True negative rate: the probability of a negative test result, conditioned on the individual truly being negative
Time frame: Through study completion, an average of 1 year
Proportion of correct predictions (true positives and true negatives) among the total cases (i.e., accuracy)
A measure of trueness: proportion of correct predictions (both true positives and true negatives) among the total number of cases examined
Time frame: Through study completion, an average of 1 year
Plan to share: Undecided — Data collected for the study will be made available to others, including de-identified participant data, at publication, via a signed data access agreement and at the discretion of the investigators' approval of the proposed use of such data
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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City of Hope Medical Center