Tokyo, Oct. 2 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059255) titled 'Reliability Assessment of Disease-Specific Patient-Reported Outcomes in Gaucher Disease and Their Correlation with Clinical Information' on Oct. 1.
Study Type:
Observational
Primary Sponsor:
Institute - Kansai Medical University
Condition:
Condition - Gaucher disease
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - We will validate the criterion-related validity and test-retest reliability of patient-reported outcomes (PROs) developed for patients with Gaucher disease, as well as the minimal clinically important distance (MID) in clinical practice.
Basic objectives2 - Others
Eligibility:
Age-lower limit - Not applicable
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - 1) At the time of consent acquisition, the patient must be 18 years of age or older; for patients under 18 years of age or patients with neurological disease, the consent must be obtained from a caregiver who is 18 years of age or older
2) Gender is not a factor
3) Individuals diagnosed with Gaucher disease
Key exclusion criteria - 1) Individuals hospitalized due to acute symptoms
2) Other individuals deemed unsuitable as research subjects by the principal investigator (or co-investigator)
Target Size - 30
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 09 Month 08 Day
Date of IRB - 2025 Year 09 Month 11 Day
Anticipated trial start date - 2025 Year 10 Month 10 Day
Last follow-up date - 2027 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067778
Disclaimer: Curated by HT Syndication.
