Clinical Application of Genetic Sequencing of Early Gastric Cancer and Gastric Adenoma Patients

NCT04665687 | Recruiting

• 1 other identifier: 2020-08-070-002
• Study Type: observational
• Target: 1,730
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Early Gastric Cancer; Gastric Adenoma

Outcome Measures

Primary Outcomes (2)

• 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

  From the date of initial treatment until the date of first recurrence or up to 2 years, whichever came first.

• 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

  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.

  From the date of initial treatment until the date of first recurrence or up to 2 years, whichever came first.

Eligibility Criteria

• Age: 19 Years - 100 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study 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.

You may qualify if:

• 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
• Those who have voluntarily consented to participate in this clinical trial

You may not qualify if:

• Those who will not yield enough samples
• Those who are considered inappropriate for this study in the discretion of the researchers

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung medical center

Seoul, South Korea

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Tissue and blood will be collected as follows from patients with early gastric cancer or precancerous gastric adenoma that satisfy the inclusion and exclusion criteria. Tissue will be collected through biopsy/endoscopic removal peformed prior to participation in this study. Biopsies will not be performed simply for research purposes. If a biopsy is performed during the follow-up process after treatment, relevant samples will be stored if an appropriate amount of the sample remains after the biopsy.

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Hyuk Lee, MD, PhD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Research Coordinator

CONTACT

82234106853; hyejung1.cho@sbri.co.kr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Samsung Medical Center

Study Record Dates

• First Submitted: November 8, 2020
• First Posted: December 14, 2020
• Study Start: December 17, 2020
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2031
• Last Updated: September 12, 2025

Record last verified: 2025-09

Locations

KR (1)