Disorders of Sexual Development and Gonadal Tumor Risk

NCT ID: NCT06682078

Last Updated: 2025-04-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-01

Study Completion Date

2024-06-01

Brief Summary

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Disorders of Sexual Development are rare and represent a spectrum of heterogeneous pathologies. The risk of developing a malignant gonadal germ cell tumor (MGCT) exists and varies according to the etiology.

The indication for prophylactic gonadectomy must be modulated and discussed for all patients. It is essential to assess each patient's individual risk.

The aim of our study is to assess gonadal tumor risk in patients with Disorders of Sexual Development according to etiology

The primary objective is to evaluate tumor risk and the indication for gonadectomy in cases of Disorders of Sexual Development according to etiology.

The secondary objectives are to evaluate the timing of gonadectomy, to monitor changes in practice over time, and to assess the contribution of imaging and/or biological tests to tumor detection.

Detailed Description

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Conditions

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Disorders of Sexual Development

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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Not applicable . Non-interventional retrospective study, only on datas.

Not applicable . Non-interventional retrospective study, only on datas.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients who underwent gonadectomy for variation in genital development between 1990 and 2022.
* Pathological anatomy examination in Lyon
* With clinical data
* With karyotype
* 3 categories:

* with genetic diagnosis
* without genetic diagnosis because searched but not found
* without genetic diagnosis because not searched

Exclusion Criteria

* Biopsies without gonadectomy
* Fetus
* Operated outside the period 1990-2022
* Lack of clinical data
* No karyotype
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Service de Chirurgie uro-viscérale pédiatrique

Bron, , France

Site Status

Countries

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France

Other Identifiers

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23-5235

Identifier Type: REGISTRY

Identifier Source: secondary_id

69HCL23_0858

Identifier Type: -

Identifier Source: org_study_id

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