Clinical Application of Genetic Sequencing of Early Gastric Cancer and Gastric Adenoma Patients
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age19-100
SponsorSamsung Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Those who are over the age of 19
Those who were histologically confirmed with early gastric cancer or precancerous gastric adenoma
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
Those whose life expectancy is more than 3 months
Disqualifiers
Those who will not yield enough samples
Those who are considered inappropriate for this study in the discretion of the researchers
Trial population
A total of 1730 patients with early gastric cancer and precancerous gastric adenoma will be enrolled. Based on previous studies, approximately 20% of the subjects are expected to have mutations. In this study, metachronous tumor recurrence rate between the mutation group and non-mutation group will be compared. In general, metachronous tumor recurrent rate after endoscopic resection for early gastric cancer or gastric ademona is reported to be 6%-10%. In this study, the metachronous tumor recurrence rate is expected to be 10% and 5% in the mutation and non-mutation group, respectively. When a two-sided chi-square test with a power of 5% and 90% type 1 error is performed, 346 and 1384 subjected are expected to be included in the mutation group and non-mutation group, respectively.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Identify biomarkers for differential diagnosis between early gastric cancer and precancerous adenoma.
Tumor's moleular profiling is assessed by following method: 1. Ion Torrent PGM Amplieq Canccer Panel 2.0 2. Nanostring copy number variation (CNV) panel 3. Immunohistochemistry: RET, ATM, PD-L1, FGFR2, MLH, EGFR, ALK, ROS, TRKA. MET, HER2, PTEN loss (EGFR,CCNEI in selected cases) 4. Illumina HiSeq2000/2500-based, MiSeq NGS targeted sequencing 5. ASFA™ Spotter
Time frame
From the date of initial treatment until the date of first recurrence or up to 2 years, whichever came first.2
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: 1. Ion Torrent PGM Amplieq Canccer Panel 2.0 2. Nanostring copy number variation (CNV) panel 3. Immunohistochemistry: RET, ATM, PD-L1, FGFR2, MLH, EGFR, ALK, ROS, TRKA. MET, HER2, PTEN loss (EGFR,CCNEI in selected cases) 4. Illumina HiSeq2000/2500-based, MiSeq NGS targeted sequencing 5. ASFA™ Spotter
Time frame
From the date of initial treatment until the date of first recurrence or up to 2 years, whichever came first.Secondary outcomes
1
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.
Time frame
From the date of initial treatment until the date of first recurrence or up to 2 years, whichever came first.Sponsors and contacts
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Source ClinicalTrials.gov