Early Gastric Cancer Clinical Trial
Official title:
Clinical Sequencing Project for Early Gastric Cancer and Precancerous Gastric Adenoma Patients for Personalized Cancer Clinic
Because advanced gastric cancer shows poor prognosis, it is important to detect early gastric cancer or precancerous gastric adenoma patients who have a cure rate of 95% or more. Moreover, a large part of early gastric cancer can be completely resected by endoscopic resection, thus ensuring a very high quality of life for patients. However, there are currently no markers that can be used for diagnosis of early gastric cancer or gastric adenoma. In addition, the biggest problem after endoscopic resection of early gastric cancer is metachronous recurrence of the cancer, which requires repeated endoscopic resection or additional surgical gastrectomy. However, there are no discovered markers for prediction of recurrence. Liquid biopsy is a method of obtaining body fluids such as gastric juice or effusion through an endoscopic inlet during gastroscopy or colonoscopy and blood. Based on the advanced analysis method, liquid biopsy reveals more genetic information than tissue biopsy. Therefore, it is highly likely to become an essential factor in future personalized medicine. Therefore, this study was designed to identify whether tumor's molercular profiling based on tissue or blood could be used for prediction of prognosis and diagnosis of early gastric cancer and precancerous gastric adenoma.
Status | Recruiting |
Enrollment | 1730 |
Est. completion date | December 31, 2022 |
Est. primary completion date | December 31, 2022 |
Accepts healthy volunteers | |
Gender | All |
Age group | 19 Years to 100 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Samsung medical center | Seoul |
Lead Sponsor | Collaborator |
---|---|
Samsung Medical Center |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Identify biomarkers for differential diagnosis between early gastric cancer and precancerous adenoma. | Tumor's moleular profiling is assessed by following method:
Ion Torrent PGM Amplieq Canccer Panel 2.0 Nanostring copy number variation (CNV) panel Immunohistochemistry: RET, ATM, PD-L1, FGFR2, MLH, EGFR, ALK, ROS, TRKA. MET, HER2, PTEN loss (EGFR,CCNEI in selected cases) Illumina HiSeq2000/2500-based, MiSeq NGS targeted sequencing ASFA™ Spotter |
From the date of initial treatment until the date of first recurrence or up to 2 years, whichever came first. | |
Primary | Indentify prognostic biomarkers for predicting recurrence of early gastric cancer and precancerous adenoma lesion. | Comparison of tumor's molecular profile between the cases of recurrence and non-recurrence.
Tumor's moleular profiling is assessed by following method: Ion Torrent PGM Amplieq Canccer Panel 2.0 Nanostring copy number variation (CNV) panel Immunohistochemistry: RET, ATM, PD-L1, FGFR2, MLH, EGFR, ALK, ROS, TRKA. MET, HER2, PTEN loss (EGFR,CCNEI in selected cases) Illumina HiSeq2000/2500-based, MiSeq NGS targeted sequencing ASFA™ Spotter |
From the date of initial treatment until the date of first recurrence or up to 2 years, whichever came first. | |
Secondary | Change in the tumor's molecular profile on serial biopsies at the time of initial treatment, 2 months after treatment, 1 year after treatment, or recurrence. | The method of tumor's moleular profiling is same as the above. | From the date of initial treatment until the date of first recurrence or up to 2 years, whichever came first. |
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