NCT02833363

Brief Summary

Helicobater pylori plays an important role in the development of gastric cancer. Eradication therapy can reducing the morbidity of gastric cancer, but can't totally prevent it especially when atrophy and more serious precancerous lesions already happened. Prior studies found the gastric bacterial difference among gastritis, intestinal metaplasia and gastric cancer. However, they didn't reach an agreement. Correa's model is widely accepted in the development of gastric cancer. The pathological change makes a more suitable environment for bacteria to overgrowth. This study are designed to analyze the gastric microbial difference of non-atrophic gastritis, atrophic gastritis, intestinal metaplasia, intraepithelial neoplasia and gastric cancer.

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
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2016

Shorter than P25 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

July 1, 2016

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

July 12, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 14, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

October 26, 2016

Status Verified

October 1, 2016

Enrollment Period

5 months

First QC Date

July 12, 2016

Last Update Submit

October 25, 2016

Conditions

Gastric MicrobiotaNon-atrophic GastritisAtrophic GastritisIntestinal MetaplasiaIntraepithelial NeoplasiaGastric CancerHelicobacter Pylori

Keywords

gastric microbiotaHelicobacter pyloriNon-atrophic GasrititisAtrophic gastritisIntestinal metaplasiaintraepithelial neoplasiaGastric cancer

Outcome Measures

Primary Outcomes (1)

  • Difference of Gastric Microbiota in the Process of Correa's Model.

    5 months

Secondary Outcomes (1)

  • Difference of Gastric Microbiota in the Process of Correa's Model.

    5 months

Study Arms (5)

patients with non-atrophic gastritis

Patients with gastritis

Patients with intestinal metaplasia

Patients with intrepithelial neoplasia

Patients with non-cardia gastric cancer

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients go through a gastric endoscopy examination with non-atrophic gastritis, atrophic gastris, intestinal metaplasia, intraepithelial neoplasia and gastric cancer.

You may qualify if:

  • Patients go through a gastric endoscopy examination with non-atrophic gastritis, atrophic gastris, intestinal metaplasia, intraepithelial neoplasia and gastric cancer.
  • Did not take any antibiotics,PPI,probiotics and chinese herbs in the past one month,and took less than one week in the past three months before the gastroscopy examination.
  • Sign the informed consent.

You may not qualify if:

  • Had been taken Helicobacter pylori eradication therapy before.
  • Previous gastrointestinal surgery.
  • During the pregnancy and lactation period.
  • With any serious diseases like liver failure,heart failure,renal failure,malignant tumor,alcoholism or any other disease that may effect the result.
  • With any mental problems.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Gastroenterology, Qilu Hospital, Shandong University

Jinan, Shandong, 250012, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

gastric mucosal samples from antrum and corpus will be collected during gastroscopy,and used for microbiota analysis by high-throughput sequencing.

MeSH Terms

Conditions

Gastritis, AtrophicCarcinoma in SituStomach Neoplasms

Condition Hierarchy (Ancestors)

GastritisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesStomach DiseasesCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by Site

Study Officials

  • Yanqing Li, MD,PHD

    Qilu Hospital of Shandong University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yanqing Li, MD,PHD

CONTACT

86-531-82169236liyanqing@sdu.edu.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice president of Qilu Hospital

Study Record Dates

First Submitted

July 12, 2016

First Posted

July 14, 2016

Study Start

July 1, 2016

Primary Completion

December 1, 2016

Study Completion

February 1, 2017

Last Updated

October 26, 2016

Record last verified: 2016-10

Locations

CN(1)