NCT01490541

Brief Summary

The predictive scores for gastric cancer in gastric intestinal metaplasia(GIM) patient: a recommendation for Thai population. Objective: To evaluate major risk factors for gastric cancer in gastric intestinal metaplasia(GIM) patient in order to propose the appropriate recommendation for Thai people. Research Design: Single center, retrospective-cohort study.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
280

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

October 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 5, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 13, 2011

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
4.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

June 25, 2012

Status Verified

June 1, 2012

Enrollment Period

1.2 years

First QC Date

December 5, 2011

Last Update Submit

June 22, 2012

Conditions

Gastric Intestinal Metaplasia

Keywords

Gastric intestinal metaplasia

Outcome Measures

Primary Outcomes (1)

  • The prevalence of early gastric cancer in gastric intestinal metaplasia(GIM) patient from 5 year-follow-up in Thai population

    In Thailand, gastric cancer patients usually presented with advance stage and carried the dismal prognosis. GIM is a well known precancerous lesion. The appropriate follow-up period in high risk GIM patient can increase the prevalence of early gastric cancer and reduce the mortality rate of gastric cancer

    Up to 5 years

Study Arms (1)

Gastric intestinal metaplasia patient

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All GIM patients in KCMH whose diagnosed from 1997 to 2005, at least 280.

You may qualify if:

  • All patients were diagnosed GIM
  • All patients have to sign the consent form

You may not qualify if:

  • Previous gastric surgery including gastrectomy and bypass surgery
  • Bleeding tendency including decompensated cirrhosis, chronic kidney disease and long-tem antiplatelets or anticoagulants
  • HIV infection
  • History of proton pump inhibitor use within 1 week
  • History of antibiotic use within 4 weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rapat Pittayanon

Bangkok, Bangkok, 10330, Thailand

RECRUITING

Related Links

Study Officials

  • Rungsun Rerknimitr, Professor

    King Chulalongkorn Memorial Hospital

    STUDY DIRECTOR

  • Rapat Pittayanon, MD

    King Chulalongkron Memorial Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rapat Pittayanon, MD

CONTACT

66813132112Rapat125@gmail.com

Nuttaphat Namjud, M.Sc.

CONTACT

66894971957ampere_nut@hotmail.com

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

December 5, 2011

First Posted

December 13, 2011

Study Start

October 1, 2011

Primary Completion

December 1, 2012

Study Completion

October 1, 2017

Last Updated

June 25, 2012

Record last verified: 2012-06

Locations

TH(1)