NCT05604378

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
460

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 3, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 28, 2022

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 28, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 28, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 3, 2022

Completed
Last Updated

November 3, 2022

Status Verified

August 1, 2022

Enrollment Period

3 months

First QC Date

October 28, 2022

Last Update Submit

October 28, 2022

Conditions

Keywords

Gastric CancerEBVMSIPrognosis

Outcome Measures

Primary Outcomes (1)

  • EBV positive gastric cancer is associated with increased Ki-67 and decreased EGFR.

    Between January 2017 and February 2022.

Study Arms (2)

EBV-positive gastric cancers

Procedure: Gastrectomy

EBV-negative gastric cancers

Procedure: Gastrectomy

Interventions

GastrectomyPROCEDURE

All patients in our study underwent gastrectomy.

EBV-negative gastric cancersEBV-positive gastric cancers

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jiwon Seo

Suwon, Gyeong-Gi-Do, 16247, South Korea

Location

MeSH Terms

Conditions

Stomach NeoplasmsEpstein-Barr Virus Infections

Interventions

Gastrectomy

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach DiseasesHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus Infections

Intervention Hierarchy (Ancestors)

Digestive System Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Kyong Hwa Jun, Ph.D.

    The Catholic University of Korea

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2022

First Posted

November 3, 2022

Study Start

August 3, 2022

Primary Completion

October 28, 2022

Study Completion

October 28, 2022

Last Updated

November 3, 2022

Record last verified: 2022-08

Locations