Clinical trial NCT05604378: Relationship of EBV-positive Gastric Cancer and Multiple Genes Associated With Gastric Carcinogenesis
Official title: Does Epstein-Barr Virus-positive Gastric Cancer Establish a Significant Relationship With the Multiple Genes Related to Gastric Carcinogenesis?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastric Cancer
EBV Infection
MSI
Keywords: Gastric Cancer
EBV
MSI
Prognosis
Lead sponsor: Saint Vincent's Hospital, Korea
Sponsor class: OTHER
First posted: 2022-11-03
Enrollment: 460
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

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.

Primary outcomes:
measure: EBV positive gastric cancer is associated with increased Ki-67 and decreased EGFR.
timeFrame: Between January 2017 and February 2022.
Secondary outcomes:
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: Jiwon Seo
state: Gyeong-Gi-Do
Study officials:
affiliation: The Catholic University of Korea
name: Kyong Hwa Jun, Ph.D.
role: STUDY_DIRECTOR
References: