NCT06723938 Phenotypic and Genotypic Characterisation of a Large, Multicentre Italian Cohort of 46, XY DSD Patients
| NCT ID | NCT06723938 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna |
| Condition | 46, XY DSD |
| Study Type | OBSERVATIONAL |
| Enrollment | 520 participants |
| Start Date | 2021-06-15 |
| Primary Completion | 2027-06-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 520 participants in total. It began in 2021-06-15 with a primary completion date of 2027-06-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Observational exploratory study of a cohort of pediatric and adolescent patients diagnosed with DSD karyotype 46,XY, a rare congenital clinical condition characterized by a disharmonic development between chromosomal sex, gonadal sex and/or phenotypic sex.
Eligibility Criteria
Inclusion Criteria: * Karyotype 46,XY DSD; * Genital ambiguity signs assessed on the basis of clinical phenotype and EMS/EGS for karyotype 46,XY DSD; * Age \< 18 years at diagnosis of 46,XY DSD; * Patients referred to the IRCCS Azienda Ospedaliero-Universitaria di Bologna since 01/01/1991 or to other participating centres since 01/01/2000; * Obtaining informed consent from patients or from parents/legal guardian of pediatric patients. Exclusion Criteria: • None.
Contact & Investigator
Federico Baronio, MD
PRINCIPAL INVESTIGATOR
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Frequently Asked Questions
Who can join the NCT06723938 clinical trial?
This trial is open to participants of all sexes, up to 18 Years, studying 46, XY DSD. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06723938 currently recruiting?
Yes, NCT06723938 is actively recruiting participants. Contact the research team at federico.baronio@aosp.bo.it for enrollment information.
Where is the NCT06723938 trial being conducted?
This trial is being conducted at Bologna, Italy, Milan, Italy, Pisa, Italy, Roma, Italy.
Who is sponsoring the NCT06723938 clinical trial?
NCT06723938 is sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna. The principal investigator is Federico Baronio, MD at IRCCS Azienda Ospedaliero-Universitaria di Bologna. The trial plans to enroll 520 participants.