NCT03978481

Brief Summary

In this study, we will observe the long-term survival rate, overall mortality rate, gastric cancer specific mortality rate, and the incidence rate of metachronous cancer in patients who received subtotal gastrectomy, with or without Helicobacter pylori eradication.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3,700

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 30, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 2, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 7, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2020

Completed
Last Updated

November 29, 2024

Status Verified

March 1, 2021

Enrollment Period

1 year

First QC Date

June 2, 2019

Last Update Submit

November 26, 2024

Conditions

Gastric Cancer

Keywords

Gastric cancerHelicobacter pyloriSubtotal gastrectomyOverall survivalMetachronous cancer

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    From date of initial curative surgery for gastric cancer, until the date of death from any cause, up to 60 months

Secondary Outcomes (2)

  • Gastric cancer-specific (disease-free) survival

    From date of initial curative surgery for gastric cancer, until the date of diagnosis of gastric cancer recurrence or the date of death, whichever comes first, up to 60 months

  • Metachronous cancer (remnant stomach cancer)

    Up to 60 months

Study Arms (2)

Eradicated group

Gastric cancer patients received subtotal gastrectomy, with Helicobacter pylori eradication

Combination Product: Helicobacter pylori eradication (combination therapy)

Negative group

Gastric cancer patients received subtotal gastrectomy, without Helicobacter pylori eradication or Helicobacter pylori negative

Interventions

Helicobacter pylori eradication (combination therapy)COMBINATION_PRODUCT

Antibiotic eradication therapy (triple or quadriple regimen)

Eradicated group

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients diagnosed with gastric cancer and received surgery (partial, distal, subtotal gastrectomy), and tested Helicobacter pylori status in Seoul National University Bundang Hospital, from 2003 to 2018

You may qualify if:

  • Patients diagnosed with gastric cancer and received surgery (partial, distal, subtotal gastrectomy), and tested Helicobacter pylori status

You may not qualify if:

  • Patients with other severe diseases (other primary cancer, severe cardiovascular, cerebral, renal, hepatic diseases)
  • Patients received palliative treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Combined Modality Therapy

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 2, 2019

First Posted

June 7, 2019

Study Start

January 30, 2019

Primary Completion

January 30, 2020

Study Completion

April 30, 2020

Last Updated

November 29, 2024

Record last verified: 2021-03

Locations

KR(1)