Genetic sequencing for people with early gastric cancer or gastric adenoma
Clinical Sequencing Project for Early Gastric Cancer and Precancerous Gastric Adenoma Patients for Personalized Cancer Clinic
This project will test whether genetic sequencing of tumor tissue, blood, and gastric fluids can find markers to diagnose early gastric cancer and predict recurrence in people with early gastric cancer or gastric adenoma.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1730 (estimated) |
| Ages | 19 Years to 100 Years |
| Sex | All |
| Sponsor | Samsung Medical Center Academic / other |
| Locations | 1 site (Seoul) |
| Trial ID | NCT04665687 on ClinicalTrials.gov |
What this trial studies
This observational project collects tumor tissue and blood (and gastric juice when available) from adults with histologically confirmed early gastric cancer or gastric adenoma at baseline and after treatment (approximately 2 months, 1 year, and at recurrence). Extracted DNA from FFPE tumor samples and matched blood will be quality-checked (Nanodrop, Qubit) and subjected to targeted mutation profiling with the Ion AmpliSeq Cancer Panel V2 and copy-number analysis using a 21-gene nCounter CNV assay. The study aims to identify diagnostic markers for early disease and molecular signatures that predict metachronous recurrence after endoscopic resection. Results will be used to explore liquid biopsy approaches for less invasive detection and post-treatment surveillance.
Who should consider this trial
Good fit: Adults (≥19 years) with histologically confirmed early gastric cancer or precancerous gastric adenoma who can provide tissue or blood samples and consent to follow-up are ideal candidates.
Not a fit: Patients who cannot provide sufficient tissue or blood samples, cannot attend the required follow-up visits, or have advanced disease or very limited life expectancy are unlikely to benefit from the study's findings.
Why it matters
Potential benefit: If successful, this work could produce blood- or gastric-fluid-based tests that detect early gastric cancer and predict recurrence, enabling less invasive treatment decisions and more personalized follow-up.
How similar studies have performed: Liquid biopsy and targeted sequencing have shown promising preliminary results in gastric and other cancers, but validated diagnostic or recurrence biomarkers for early gastric cancer have not yet been established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Those who are over the age of 19 2. Those who were histologically confirmed with early gastric cancer or precancerous gastric adenoma 3. Patients with early gastric cancer or precancerous gastric adenoma falling under the above criteria who have excess tissue stored from previous non-research purpose biopsy/endodoscopic removal for treatment and diagnosis 4. Those whose life expectancy is more than 3 months 5. Those who have voluntarily consented to participate in this clinical trial Exclusion Criteria: 1. Those who will not yield enough samples 2. Those who are considered inappropriate for this study in the discretion of the researchers
Where this trial is running
Seoul
- Samsung medical center — Seoul, South Korea (Recruiting)
Study contacts
- Principal investigator: Hyuk Lee, MD, PhD — Samsung Medical Center
- Study coordinator: Clinical Research Coordinator
- Email: hyejung1.cho@sbri.co.kr
- Phone: 82234106853
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.