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

Sponsor
Saint Vincent's Hospital, Korea (Other)
Overall Status
Completed
CT.gov ID
NCT05604378
Collaborator
(none)
460
1
2.8
162.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Gastrectomy

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.

Study Design

Study Type:
Observational
Actual Enrollment :
460 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Does Epstein-Barr Virus-positive Gastric Cancer Establish a Significant Relationship With the Multiple Genes Related to Gastric Carcinogenesis?
Actual Study Start Date :
Aug 3, 2022
Actual Primary Completion Date :
Oct 28, 2022
Actual Study Completion Date :
Oct 28, 2022

Arms and Interventions

Arm Intervention/Treatment
EBV-positive gastric cancers

Procedure: Gastrectomy
All patients in our study underwent gastrectomy.

EBV-negative gastric cancers

Procedure: Gastrectomy
All patients in our study underwent gastrectomy.

Outcome Measures

Primary Outcome Measures

  1. EBV positive gastric cancer is associated with increased Ki-67 and decreased EGFR. [Between January 2017 and February 2022.]

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Jiwon Seo Suwon Gyeong-Gi-Do Korea, Republic of 16247

Sponsors and Collaborators

  • Saint Vincent's Hospital, Korea

Investigators

  • Study Director: Kyong Hwa Jun, Ph.D., The Catholic University of Korea

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Saint Vincent's Hospital, Korea
ClinicalTrials.gov Identifier:
NCT05604378
Other Study ID Numbers:
  • VC22RISI0177
First Posted:
Nov 3, 2022
Last Update Posted:
Nov 3, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Saint Vincent's Hospital, Korea
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 3, 2022