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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT03250091
Date of registration:	21/07/2017
Prospective Registration:	No
Primary sponsor:	University of Latvia
Public title:	Surveillance of Patients With Precancerous Lesions of the Stomach
Scientific title:	Surveillance Strategies of Patients With Precancerous Conditions and Lesions in the Stomach
Date of first enrolment:	June 19, 2017
Target sample size:	2000
Recruitment status:	Recruiting
URL:	https://clinicaltrials.gov/show/NCT03250091
Study type:	Observational
Study design:
Phase:

Countries of recruitment
Latvia

Contacts

Name:	Marcis Leja, Prof.,PhD
Address:
Telephone:
Email:
Affiliation:	Institute of Clinical and Preventive Medicine, University of Latvia

Name:	Ilze Kikuste, PhD
Address:
Telephone:	+317 28357349
Email:	ikikuste@gmail.com
Affiliation:

Name:	Ilze Kikuste, PhD
Address:
Telephone:	28357349
Email:	ikikuste@gmail.com
Affiliation:

Key inclusion & exclusion criteria

Inclusion Criteria:

Patients undergoing upper endoscopy Motivation to participate in the study Signed consent

Exclusion Criteria:

Known gastric cancer Unwillingness or inability to co-operate

Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Gastric Dysplasia

Gastric Cancer

Gastric Atrophy

Gastric Intestinal Metaplasia

Intervention(s)

Procedure: Faecal sample acquisition

Procedure: Upper endoscopy with biopsies

Procedure: Plasma/serum sampling

Procedure: Biopsies for gastric microbiota

Primary Outcome(s)

Risk stratification [Time Frame: At baseline]

Secondary Outcome(s)

Gastric, faecal microbiome in cancer patients and patients with precancerous lesions [Time Frame: At baseline and then 1 and 3 years after the intervention depending on hystopathological report through study completion]

Scheduled follow-up procedures (gastroscopies) for high risk group patients [Time Frame: At baseline and then 1 and 3 years after the intervention depending on hystopathological report through study completion]

Secondary ID(s)

2915

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Digestive Diseases Centre GASTRO

Riga East University Hospital (Latvia)

Academic Histology Laboratory (Latvia)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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