Tokyo, May 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061343) titled 'DrHyQ6 Reliability and Instrument Validity in the Japanese Version' on May 1.

Study Type: Observational

Primary Sponsor: Institute - Department of Clinical Research, NHO Mie National Hospital

Condition: Condition - Drug hypersensitivity reactions Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The objective of this study is to evaluate the reliability and validity of the Japanese version of the DrHyQ6 (Drug Hypersensitivity Quality of Life Questionnaire-6), a health-related quality of life (HRQoL) assessment tool specific to drug hypersensitivity reactions (DHR), through a prospective observational study. Basic objectives2 - Others

Eligibility: Age-lower limit - 2 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - This study is intended for patients who meet all of the following criteria: (1) Patients with suspected drug hypersensitivity reactions (DHR) or a documented history of such reactions in their medical records (2) Patients aged 2 years or older (3) Patients who have provided written informed consent (4) Patients or their guardians who are capable of understanding and responding to a questionnaire in Japanese (5) Participants in the retest reliability evaluation (adult subgroup) Key exclusion criteria - Patients who meet any of the following criteria will not be included in this study. (1) Individuals deemed unable to complete the questionnaire reliably (2) Individuals in an acute medical emergency (3) Individuals exhibiting acute severe psychiatric symptoms (4) Any other individuals deemed ineligible by the principal investigator or attending physician from a medical or ethical standpoint Target Size - 100

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 04 Month 15 Day Date of IRB - 2026 Year 04 Month 15 Day Anticipated trial start date - 2026 Year 05 Month 01 Day Last follow-up date - 2029 Year 04 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070120

Disclaimer: Curated by HT Syndication.