Relationship of EBV-positive Gastric Cancer and Multiple Genes Associated With Gastric Carcinogenesis

NCT ID: NCT05604378

Last Updated: 2022-11-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 460 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-08-03
• Study Completion Date: 2022-10-28

Brief Summary

The data of 460 gastric cancer patients who underwent curative gastrectomy with D2 lymph node dissection between January 2017 and February 2022 were analyzed. The clinicopathological features and prognosis of the patients with EBV-positive gastric cancers were compared with those of EBV-negative gastric cancers. Immunohistochemistry for epidermal growth factor receptor (EGFR), C-erb B2, Ki-67, and p53 was performed. Additionally, in situ hybridization was conducted to detect EBV, and microsatellite instability (MSI) analysis was used to assess the deficiency in mismatch repair (MMR) genes.

Detailed Description

This study collected consecutively the data of 463 patients with gastric adenocarcinomas who underwent curative gastrectomy with lymphadenectomy at our institution between January 2017 and February 2022. The Institutional Review Board of St. Vincent's Hospital, The Catholic University of Korea approved this study (VC22RISI0177). Informed consent of the patients was waived because of the retrospective nature of the study. The inclusion criteria were: (1) gastric adenocarcinoma; (2) R0 resection; (3) formalin-fixed paraffin-embedded tissue (FFPE) blocks available for analysis. Patients who had undergone previous surgery, palliative resection, chemotherapy, or radiation therapy were excluded. All patients underwent gastrectomy with lymphadenectomy based on the Korean Practice Guideline for Gastric Cancer 2018 [18]. After the surgery, clinical follow-up data were collected every 6 months during the first year and then every year thereafter. Disease-free survival (DFS) was defined as the length of time from curative surgery to the first tumor recurrence or distant metastasis. Overall survival (OS) was defined as the time from curative surgery to death from any cause.

Conditions

Gastric Cancer; EBV Infection; MSI

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

EBV-positive gastric cancers

Gastrectomy

Intervention Type: PROCEDURE

All patients in our study underwent gastrectomy.

EBV-negative gastric cancers

Gastrectomy

Intervention Type: PROCEDURE

All patients in our study underwent gastrectomy.

Interventions

Gastrectomy

All patients in our study underwent gastrectomy.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• (1) gastric adenocarcinoma; (2) R0 resection; (3) formalin-fixed paraffin-embedded tissue (FFPE) blocks available for analysis.

Exclusion Criteria

• Patients who had undergone previous surgery, palliative resection, chemotherapy, or radiation therapy were excluded.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Saint Vincent's Hospital, Korea

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kyong Hwa Jun, Ph.D.

Role: STUDY_DIRECTOR

The Catholic University of Korea

Locations

Jiwon Seo

Suwon, Gyeong-Gi-Do, South Korea

Countries

South Korea

Other Identifiers

VC22RISI0177

Identifier Type: -

Identifier Source: org_study_id