Tokyo, Dec. 25 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060166) titled 'Features of duodenal lesions in patients with familial adenomatous polyposis: Multicenter retrospective cohort study' on Dec. 25.
Study Type:
Observational
Primary Sponsor:
Institute - Hyogo Medical University School of Medicine
Condition:
Condition - Familial adenomatous polyposis
Classification by malignancy - Malignancy
Genomic information - YES
Objective:
Narrative objectives1 - To compare the time to progression of Spigelman stage between patients treated at IDP-performing institutions (IDP group) and those at institutions not performing IDP (non-IDP group).
Basic objectives2 - Others
Eligibility:
Age-lower limit - 16
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Patients who visited Hyogo Medical University Hospital or participating institutions between January 1, 2016 and December 31, 2023, were clinically diagnosed with familial adenomatous polyposis (FAP), and were found to have duodenal adenomas or duodenal carcinoma on esophagogastroduodenoscopy during the observation period.
Key exclusion criteria - (a) Fewer than two EGDs during observation
(b) Prior surgeries preventing duodenal observation (gastrectomy, pancreaticoduodenectomy, etc.)
(c) Current or past chemotherapy for non-duodenal malignancies
(d) Inflammatory bowel disease
(e) Opt-out request from the participant
Target Size - 280
Recruitment Status:
Recruitment status - No longer recruiting
Date of protocol fixation - 2024 Year 12 Month 11 Day
Date of IRB - 2024 Year 12 Month 24 Day
Anticipated trial start date - 2024 Year 12 Month 25 Day
Last follow-up date - 2025 Year 10 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068777
Disclaimer: Curated by HT Syndication.
