Disorders of Sexual DevelopmentDEV-GEN-RiTuGoNCT06682078
Disorders of Sexual Development and Gonadal Tumor Risk
An observational study of Disorders of Sexual Development, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Disorders of Sexual Development
- What is being tested?
- Not applicable . Non-interventional retrospective study, only on datas.
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2023to 1 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who underwent gonadectomy for Disorders of Sexual Development between 1990 and 2022, followed by Dr. Daniela Gorduza in the Pediatric Uro-Visceral Surgery Department of the hospital Femme-Mère-Enfant.
Who may be able to join
- 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
Who cannot join
- Biopsies without gonadectomy
- Fetus
- Operated outside the period 1990-2022
- Lack of clinical data
- No karyotype
Trial locations and contacts
1 site in 1 country.
About this study
Official title: DEV-GEN-RiTuGo - Assessment of Individual Gonadal Tumor Risk in Patients With Disorders of Sexual Developpment According to the Etiology.
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.
Read more
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.
- Conditions
- Disorders of Sexual Development
- Being tested
- Not applicable . Non-interventional retrospective study, only on datas.
- Keywords
- surgery, pediatrics, Urology, Endocrinology, Gonadoblastoma, Dysgerminoma, neoplasms, gonadal tissue, sexual development, oncology, gonadal dysgenesis, androgen-insensitivity syndrome, testicular regression syndrome, anti-mullerian hormone
- Medical subject headings
- Disorders of Sex Development, Gonadoblastoma, Dysgerminoma, Neoplasms, Gonadal Dysgenesis, Androgen-Insensitivity Syndrome, Anorchia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Not applicable . Non-interventional retrospective study, only on datas.Other
Not applicable . Non-interventional retrospective study, only on datas.
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence or absence of gonadal tumor lesion after gonadectomy, in case of Disorders of sexual development (DSD) according to anatomo-pathological analysis.
Datas about the gonadectomy surgical pieces performed between1990 and 2022 are reviewed for the study by Dr Frédérique Dijoud, anatomo-pathologist at the DEV-GEN CRMR in Lyon, to confirm the présence or absence of a gonadal tumor lesion, in order to avoid intra- and inter-reader interpretation bias.
Measured: The outcome measure will be assessed and the datas reported for each patient will be collected, from birth until the study completion date, or by default until the date of death from any cause. Datas will be collected during the 10 months of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start1 Sep 2023
- Primary completion1 Dec 2023
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disorders of Sexual DevelopmentStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06682078
- Sponsor's protocol ID
- 69HCL23_0858
- Other IDs
- 23-5235
- Acronym
- DEV-GEN-RiTuGo
- Status last verified
- Nov 2024
- First submitted
- 22 Aug 2023
- Last updated
- 13 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DEV-GEN-RiTuGo - Assessment of Individual Gonadal Tumor Risk in Patients With Disorders of Sexual Developpment According to the Etiology.
- ClinicalTrials.gov ID
- NCT06682078
- Acronym / sponsor ID
- DEV-GEN-RiTuGo / 69HCL23_0858
- Conditions
- Disorders of Sexual Development
- Keywords
- surgery, pediatrics, Urology, Endocrinology, Gonadoblastoma, Dysgerminoma, neoplasms, gonadal tissue
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 12 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who underwent gonadectomy for Disorders of Sexual Development between 1990 and 2022, followed by Dr. Daniela Gorduza in the Pediatric Uro-Visceral Surgery Department of the hospital Femme-Mère-Enfant.
Key inclusion criteria (8 listed)
- 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:
Key exclusion criteria (5 listed)
- Biopsies without gonadectomy
- Fetus
- Operated outside the period 1990-2022
- Lack of clinical data
- No karyotype
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Not applicable . Non-interventional retrospective study, only on datas.Not applicable . Non-interventional retrospective study, only on datas. | Other | – |
Primary outcome
Presence or absence of gonadal tumor lesion after gonadectomy, in case of Disorders of sexual development (DSD) according to anatomo-pathological analysis.
Time frame: The outcome measure will be assessed and the datas reported for each patient will be collected, from birth until the study completion date, or by default until the date of death from any cause. Datas will be collected during the 10 months of the study
Datas about the gonadectomy surgical pieces performed between1990 and 2022 are reviewed for the study by Dr Frédérique Dijoud, anatomo-pathologist at the DEV-GEN CRMR in Lyon, to confirm the présence or absence of a gonadal tumor lesion, in order to avoid intra- and inter-reader interpretation bias.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Disorders of Sexual Development, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence or absence of gonadal tumor lesion after gonadectomy, in case of Disorders of sexual development (DSD) according to anatomo-pathological analysis. (time frame: The outcome measure will be assessed and the datas reported for each patient will be collected, from birth until the study completion date, or by default until the date of death from any cause. Datas will be collected during the 10 months of the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2025.