Tokyo, July 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061813) titled 'A Multicenter Prospective Study on the Clinical Implementation of Rapid Genomic Diagnosis and the Development of a Family Support Program for Neonates with Differences of Sex Development and Uncertain Legal Sex Assignment' on July 1.

Study Type: Observational

Primary Sponsor: Institute - Tokyo Metropolitan Children's Medical Center

Condition: Condition - Differences of Sex Development Classification by malignancy - Others Genomic information - YES

Objective: Narrative objectives1 - This multicenter, prospective observational (registry) study evaluates the clinical feasibility of rapid genomic diagnosis and the usefulness of a multidisciplinary family-support program for newborns with differences of sex development (DSD) in whom legal sex assignment is difficult. It also assesses the effectiveness of shared decision-making support for sex assignment, longitudinal changes in parental psychological status and family quality of life, and differences in outcomes according to the availability of multidisciplinary care, while establishing a nationwide registry of neonatal DSD. Basic objectives2 - Others

Eligibility: Age-lower limit - Not applicable Age-upper limit - 14 days-old >= Gender - Male and Female Key inclusion criteria - 1. Newborns with DSD under 14 days of age in whom the attending physician has deferred legal sex assignment, with an External Genitalia Score (EGS) of >=0.5 that is below the 10th percentile for boys by gestational age (10.5 at >=33 weeks, 9.0 at 28-32 weeks, 8.5 at <28 weeks). 2. Patients who began care at a participating site of this study. 3. Patients for whom written consent has been obtained from a parent (legally authorized representative). Key exclusion criteria - 1. Patients with a prenatally identified numerical sex-chromosome abnormality or similar finding. 2. Patients with a high likelihood of congenital adrenal hyperplasia, such as those with skin hyperpigmentation. 3. Patients judged to have a poor life prognosis due to serious comorbidities. 4. Any other patient judged unsuitable by the principal investigator. Target Size - 50

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 06 Month 05 Day Date of IRB - 2026 Year 02 Month 12 Day Anticipated trial start date - 2026 Year 07 Month 01 Day Last follow-up date - 2035 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070732

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