Tokyo, June 10 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061843) titled 'A Retrospective Study to Evaluate the Accuracy of Helicobacter pylori Diagnostic Tests' on June 9.
Study Type:
Others,meta-analysis etc
Primary Sponsor:
Institute - Keio University School of Medicine
Condition:
Condition - H .pylori infection
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - Several diagnostic methods are available for Helicobacter pylori infection, including the urea breath test, stool antigen test, serum antibody test, culture, rapid urease test, and histological examination. In November 2022, gastric fluid PCR testing for H. pylori and clarithromycin resistance genes became covered by the Japanese national health insurance system, enabling diagnosis without gastric biopsy during endoscopy. Although gastric fluid PCR has shown high concordance with established diagnostic methods, its accuracy in patients after H. pylori eradication therapy remains unclear. This retrospective study aims to evaluate the accuracy of gastric fluid PCR testing for identifying current infection, uninfected status, and post-eradication status.
Basic objectives2 - Efficacy
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Patients who underwent testing for Helicobacter pylori infection at Keio University Hospital between September 2022 and August 2024.
Key exclusion criteria - Patients who declined the use of their clinical data for research purposes.
Recruitment Status:
Recruitment status - No longer recruiting
Date of protocol fixation - 2024 Year 04 Month 08 Day
Date of IRB - 2024 Year 04 Month 24 Day
Anticipated trial start date - 2024 Year 04 Month 24 Day
Last follow-up date - 2026 Year 12 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070768
Disclaimer: Curated by HT Syndication.
