EndocrinologyPECAN-VDGNCT06687252
Retrospective Analysis of the Neonatal Management of Patients with an Antenatal Diagnosis of Genital Development Variation At the Hospital of Lyon
An observational study of Endocrinology and Disorders of Sexual Development, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Variations in genital development (VDG) account for 0.5% to 1% of births. Advances in ultrasound techniques, as well as in prenatal diagnosis techniques, particularly in genetics, have led to improvements in the prenatal diagnosis of these pathologies. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Endocrinology, Disorders of Sexual Development, Prenatal Diagnosis
- How many people
- 170 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2023to 1 Jul 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: All fetuses referred to the hospital Femme-Mère-Enfant and the hospital Croix Rousse Pluridisciplinary Centers for Prenatal Diagnosis (CPDPNs), for antenatal diagnosis (DAN) for a suspected isolated Disorders of Sexual Development (DSD) from 01/01/2013 to 31/12/2023.
Who may be able to join
- Fetuse of the hospital Femme-Mère-Enfant, the hospital Croix Rousse and Lyon-Sud hospital, reffered to Pluridisciplinary Centers for Prenatal Diagnosis (CPDPNs) for antenatal diagnosis (DAN) for a suspected isolated Disorders of Sexual Development (DSD) from January 2013 to December 2022.
- Intrauterine growth retardation (RCIU), a muscular or minor ventricular septal defect, or a pyloric dilatation are not considered as an associated malformation.
Who cannot join
- No follow-up file at the CPDPN of the hospital Femme-Mère-Enfant, the hospital Croix Rousse or of Lyon-Sud hospital.
- Lack of data and identification of the child born.
- Referred to CPDPN for urinary malformation including no VDG.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ancillary Study of Retrospective Analysis of Neonatal Management of Patients with ANtenatal Diagnosis of Variation of Genital Development At Lyon Hospital
Variations in genital development (VDG) account for 0.5% to 1% of births. Advances in ultrasound techniques, as well as in prenatal diagnosis techniques, particularly in genetics, have led to improvements in the prenatal diagnosis of these pathologies. However, to date, there is no consensus on etiological research and standardized management of these patients and their families, once VDG has been detected.
The value of multidisciplinary management has already been demonstrated, but a number of grey areas remain: the frequency of false-positive ultrasound findings, the place of invasive antenatal diagnostic tests, the role left to parents during the diagnostic process, the frequency of associated malformations discovered post-natally, and how to prepare for immediate management at birth.
Read more
The aim of this study is to improve the management of patients and their families as soon as a Disorders of Sexual Development is detected antenatally.
The primary objective is to describe the management, particularly complementary investigations performed in the antenatal management of ultrasound diagnoses of Disorders of Sexual Development over the last 10 years.
The secondary objectives are :
- To determine the correlation between pre- and post-natal morphological phenotype and the proportion of false positives in antenatal ultrasound diagnosis.
- To characterize prenatally diagnosed Disorders of Sexual Development
- To determine the proportion of isolated prenatally-diagnosed Disorders of Sexual Development that turn out not to be isolated during postnatal follow-up.
- The evaluation of the care pathway :
- To establish the frequency of prenatal psychological support for parents
- To establish the role of parents in prenatal diagnosis strategy decisions at our center
- Conditions
- Endocrinology, Disorders of Sexual Development, Prenatal Diagnosis, Psychology, Gonadal Dysgenesis, Androgen Abnormalities
- Keywords
- Endocrinology, Disorders of Sexual Development, Prenatal diagnosis, Psychology, Gonadal dysgenesis, Androgens, Hypospadias, Bladder extrophy, Sexual development, Turner syndrome, Klinefelter's syndrome, Gonadal dysgenesis, mixed, Ovotesticular disorders of sex development, Chimera
- Medical subject headings
- Disorders of Sex Development, Gonadal Dysgenesis, Hypospadias, Bladder Exstrophy, Turner Syndrome, Klinefelter Syndrome, Gonadal Dysgenesis, Mixed, Ovotesticular Disorders of Sex Development
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| All fetuses referred to the HFME and Croix Rousse CPDPNs for antenatal diagnostic consultation (DAN) | Non-interventional retrospective study, only on datas for suspected isolated variation in genital development (VDG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ancillary Study of Retrospective Analysis of Neonatal Management of Patients with ANtenatal Diagnosis of Variation of Genital Development at Lyon Hospital
Number and type of complementary investigations performed as part of antenatal management following ultrasound diagnoses of Disorders of Sexual Development over the past 10 years.
Measured: From January 2013 to December 2022.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2024
- Study start1 Oct 2023
- Primary completion1 Nov 2023
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndocrinologyStudies 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
- 170 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
- NCT06687252
- Sponsor's protocol ID
- 69HCL23_5313
- Acronym
- PECAN-VDG
- Status last verified
- May 2024
- First submitted
- 21 May 2024
- Last updated
- 13 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ancillary Study of Retrospective Analysis of Neonatal Management of Patients with ANtenatal Diagnosis of Variation of Genital Development At Lyon Hospital
- ClinicalTrials.gov ID
- NCT06687252
- Acronym / sponsor ID
- PECAN-VDG / 69HCL23_5313
- Conditions
- Endocrinology, Disorders of Sexual Development, Prenatal Diagnosis, Psychology, Gonadal Dysgenesis, Androgen Abnormalities
- Keywords
- Endocrinology, Disorders of Sexual Development, Prenatal diagnosis, Psychology, Gonadal dysgenesis, Androgens, Hypospadias, Bladder extrophy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 13 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.
Variations in genital development (VDG) account for 0.5% to 1% of births. Advances in ultrasound techniques, as well as in prenatal diagnosis techniques, particularly in genetics, have led to improvements in the prenatal diagnosis of these pathologies. However, to date, there is no consensus on etiological research and standardized management of these patients and their families, once VDG has been detected.
The value of multidisciplinary management has already been demonstrated, but a number of grey areas remain: the frequency of false-positive ultrasound findings, the place of invasive antenatal diagnostic tests, the role left to parents during the diagnostic process, the frequency of associated malformations discovered post-natally, and how to prepare for immediate management at birth.
The aim of this study is to improve the management of patients and their families as soon as a Disorders of Sexual Development is detected antenatally.
The primary objective is to describe the management, particularly complementary investigations performed in the antenatal management of ultrasound diagnoses of Disorders of Sexual Development over the last 10 years.
The secondary objectives are :
- To determine the correlation between pre- and post-natal morphological phenotype and the proportion of false positives in antenatal ultrasound diagnosis.
- To characterize prenatally diagnosed Disorders of Sexual Development
- To determine the proportion of isolated prenatally-diagnosed Disorders of Sexual Development that turn out not to be isolated during postnatal follow-up.
- The evaluation of the care pathway :
- To establish the frequency of prenatal psychological support for parents
- To establish the role of parents in prenatal diagnosis strategy decisions at our center
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All fetuses referred to the HFME and Croix Rousse CPDPNs for antenatal diagnostic consultation (DAN) | – | –Non-interventional retrospective study, only on datas for suspected isolated variation in genital development (VDG) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All fetuses referred to the hospital Femme-Mère-Enfant and the hospital Croix Rousse Pluridisciplinary Centers for Prenatal Diagnosis (CPDPNs), for antenatal diagnosis (DAN) for a suspected isolated Disorders of Sexual Development (DSD) from 01/01/2013 to 31/12/2023.
Key inclusion criteria (2 listed)
- Fetuse of the hospital Femme-Mère-Enfant, the hospital Croix Rousse and Lyon-Sud hospital, reffered to Pluridisciplinary Centers for Prenatal Diagnosis (CPDPNs) for antenatal diagnosis (DAN) for a suspected isolated Disorders of Sexual Development (DSD) from January 2013 to December 2022.
- Intrauterine growth retardation (RCIU), a muscular or minor ventricular septal defect, or a pyloric dilatation are not considered as an associated malformation.
Key exclusion criteria (3 listed)
- No follow-up file at the CPDPN of the hospital Femme-Mère-Enfant, the hospital Croix Rousse or of Lyon-Sud hospital.
- Lack of data and identification of the child born.
- Referred to CPDPN for urinary malformation including no VDG.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Ancillary Study of Retrospective Analysis of Neonatal Management of Patients with ANtenatal Diagnosis of Variation of Genital Development at Lyon Hospital
Time frame: From January 2013 to December 2022.
Number and type of complementary investigations performed as part of antenatal management following ultrasound diagnoses of Disorders of Sexual Development over the past 10 years.
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 Nov 2024.
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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 Endocrinology and 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 2 inclusion and 3 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 Nov 2024. 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?
Ancillary Study of Retrospective Analysis of Neonatal Management of Patients with ANtenatal Diagnosis of Variation of Genital Development at Lyon Hospital (time frame: From January 2013 to December 2022.). 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 Nov 2024.