Gastropanel for Gastric Atrophy and Cancer Risk Assessment
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02114411|
Recruitment Status : Unknown
Verified January 2018 by Biohit Healthcare Ltd.
Recruitment status was: Recruiting
First Posted : April 15, 2014
Last Update Posted : January 18, 2018
|Condition or disease||Intervention/treatment|
|Gastritis, Atrophic Stomach Neoplasms||Procedure: GastroPanel test Procedure: Gastroscopy|
|Study Type :||Observational|
|Estimated Enrollment :||250 participants|
|Official Title:||Gastropanel *for Early Detection of Gastric Atrophy and Gastric Cancer Risk|
|Actual Study Start Date :||January 31, 2017|
|Estimated Primary Completion Date :||October 2018|
|Estimated Study Completion Date :||January 31, 2019|
Patients (45 years and older, both genders) with dyspepsia referred for the GastroPanel test and gastroscopy with multiple bisopies at Homerton University Hospital (London, United Kingdom).
Procedure: GastroPanel test
Dyspeptic patients will be referred for the GastroPanel test, containing four biomarkers specific for the gastric mucosa: 1) Pepsinogen I (P-PGI), 2) Pepsinogen II (P-PGII), 3) Gastrin-17 (P-G-17) and 4) H. pylori antibody (P-HpAb).
Dyspeptic patients will undergo gastroscopy examination, with targeted biopsies from the antrum and corpus, following the protocol of the OLGA classification for chronic gastritis and Sydney Classification.
- Sensitivity and Specificity of the GastroPanel test for the detection of AG [ Time Frame: Within six weeks from enrolment ]Performance indicators (sensitivity, specificity, positive predictive value, PPV, negative predictive value, NPV and their 95%CI) of individual markers and whole GastroPanel test will be calculated separately for each study endpoint, using the STATA/SE software . The area under ROC (Receiver Operating Characteristics) called AUC, will be identified for each biomarker at each endpoint. Because GastroPanel is a quantitative ELISA test, these ROC curves can be used to identify the optimal sensitivity/specificity balance that gives each biomarker an optimal threshold for detection of each study endpoint. Significance of the difference between AUC values can be estimated using STATA's roccomb test with 95%CI.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02114411
|Homerton University Hospital||Recruiting|
|London, Hackney, United Kingdom, E9 6SR|
|Contact: Cinzia Papadia, MD +44 (0) 0208 510 5555 ext 5197 email@example.com|
|Principal Investigator: Cinzia Papadia, MD|
|Principal Investigator:||Cinzia Papadia, MD||Homerton University Hospital|
|Study Director:||Ray Shidrawi, MD||Homerton University Hospital|
|Study Chair:||Marco Novelli, MD||University College, London|