Classic Congenital Adrenal HyperplasiaCAH - RECNCT07781267
Pediatric Congenital Adrenal Hyperplasia Management: Regret and Long-term Outcomes
An observational study of Classic Congenital Adrenal Hyperplasia and 21-Hydroxylase Deficiency, run by University Hospital, Lille at 1 site in France.
Trial summary
Congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency is a chronic endocrine disorder, often diagnosed in the neonatal period. Severe forms may lead to genital virilization in afected girls and adrenal crises. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Classic Congenital Adrenal Hyperplasia, 21-Hydroxylase Deficiency
- What is being tested?
- questionnaire
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 8 Jul 2026to 8 Mar 2027
- How long will I take part?
- 1 Week
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with classic congenital adrenal hyperplasia (CAH) followed in the departments of gynecology, endocrinology, and pediatrics at Lille University Hospital, France.
Who may be able to join
- Adult patients aged 18 years or older
- Diagnosis of classic congenital adrenal hyperplasia due to 21-hydroxylase deficiency
- Followed at Lille University Hospital
- Able to understand the study information and complete the questionnaires in French
- Having provided written informed consent
Who cannot join
- Patients younger than 18 years
- Non-classic forms of congenital adrenal hyperplasia
- Inability to understand the study information or to complete the questionnaires
- Refusal to participate or lack of informed consent
- Severe cognitive impairment or psychiatric condition preventing reliable questionnaire completion
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de Lille
Lille, 59000
Sophie CATTEAU JONARD, PhD, +33 3 20 44 63 09, Sophie.catteau@chu-lille.fr
Sophie CATTEAU JONARD, PhD
About this study
Official title: Evaluation of Potential Regret Related to Pediatric Surgical and Medical Management of Congenital Adrenal Hyperplasia, and Analysis of Long-term Outcomes.
Congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency is a chronic endocrine disorder, often diagnosed in the neonatal period. Severe forms may lead to genital virilization in afected girls and adrenal crises. Management includes lifelong hormone replacement therapy and, historically, early genital surgery, although recent guidelines recommend delaying non-urgent procedures to preserve patient autonomy.This study hypothesizes that pediatric management, particularly early surgical interventions, may influence long-term satisfaction and the expression of regret in adulthood. We will conduct an observational cross-sectional study including adult patients diagnosed with CAH during childhood. Data will be collected using standardized questionnaires assessing medical regret, quality of life, sexual function, and psychological outcomes, together with clinical characteristics and past medical and surgical history.The primary outcome is the prevalence of regret related to pediatric care. Secondary outcomes include quality of life, sexual satisfaction, psychological status, and adaptation of hormonal therapy from adolescence to adulthood. Patient-reported outcomes (regret, quality of life, sexual function, and psychological outcomes) will be assessed in female participants only, male participants will be included for the evaluation of hormonal treatment adaptation.
- Being tested
- questionnaire
- Keywords
- congenital adrenal hyperplasia, regret, surgery, treatment, quality of life
- Medical subject headings
- Congenital adrenal hyperplasia due to 21 hydroxylase deficiency, Adrenal Hyperplasia, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaireOther
Standardized questionnaires assessing regret related to pediatric management, quality of life, sexual function, and psychological outcomes.
What is being measured
The primary outcome is the main question the study is designed to answer.
Regret related to pediatric management
Regret related to pediatric management assessed by the Decision Regret Scale (DRS)
Measured: At study inclusion (baseline)
Secondary outcomes (4)
Quality of life
Quality of life assessed by the WHOQOL-BREF questionnaire
Measured: at study inclusion (baseline)
Sexual function
Sexual function assessed by the Arizona Sexual Experience Scale (ASEX)
Measured: at study inclusion (baseline)
Symptoms of anxiety and depression
Symptoms of anxiety and depression assessed by the Hospital Anxiety and Depression Scale (HADS)
Measured: at study inclusion
Adaptation of hormonal treatment from adolescence to adulthood
Adaptation of hormonal treatments from adolescence to adulthood, assessed from medical history
Measured: at study inclusion (baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2026
- Study start8 Jul 2026
- Primary completion8 Mar 2027 (estimated)
- Study completion8 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Classic Congenital Adrenal HyperplasiaStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07781267
- Sponsor's protocol ID
- 2022/0207
- Other IDs
- 2026-A00189-42
- Acronym
- CAH - REC
- Status last verified
- Jul 2026
- First submitted
- 19 Aug 2026
- Last updated
- 24 Aug 2026
- 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 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Potential Regret Related to Pediatric Surgical and Medical Management of Congenital Adrenal Hyperplasia, and Analysis of Long-term Outcomes.
- ClinicalTrials.gov ID
- NCT07781267
- Acronym / sponsor ID
- CAH - REC / 2022/0207
- Keywords
- congenital adrenal hyperplasia, regret, surgery, treatment, quality of life
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 8 Jul 2026 (actual)
- Primary completion
- 8 Mar 2027 (estimated)
- Study completion
- 8 Mar 2027 (estimated)
- First posted
- 24 Aug 2026 (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.
Congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency is a chronic endocrine disorder, often diagnosed in the neonatal period. Severe forms may lead to genital virilization in afected girls and adrenal crises. Management includes lifelong hormone replacement therapy and, historically, early genital surgery, although recent guidelines recommend delaying non-urgent procedures to preserve patient autonomy.This study hypothesizes that pediatric management, particularly early surgical interventions, may influence long-term satisfaction and the expression of regret in adulthood. We will conduct an observational cross-sectional study including adult patients diagnosed with CAH during childhood. Data will be collected using standardized questionnaires assessing medical regret, quality of life, sexual function, and psychological outcomes, together with clinical characteristics and past medical and surgical history.The primary outcome is the prevalence of regret related to pediatric care. Secondary outcomes include quality of life, sexual satisfaction, psychological status, and adaptation of hormonal therapy from adolescence to adulthood. Patient-reported outcomes (regret, quality of life, sexual function, and psychological outcomes) will be assessed in female participants only, male participants will be included for the evaluation of hormonal treatment adaptation.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Week
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with classic congenital adrenal hyperplasia (CAH) followed in the departments of gynecology, endocrinology, and pediatrics at Lille University Hospital, France.
Key inclusion criteria (5 listed)
- Adult patients aged 18 years or older
- Diagnosis of classic congenital adrenal hyperplasia due to 21-hydroxylase deficiency
- Followed at Lille University Hospital
- Able to understand the study information and complete the questionnaires in French
- Having provided written informed consent
Key exclusion criteria (5 listed)
- Patients younger than 18 years
- Non-classic forms of congenital adrenal hyperplasia
- Inability to understand the study information or to complete the questionnaires
- Refusal to participate or lack of informed consent
- Severe cognitive impairment or psychiatric condition preventing reliable questionnaire completion
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 |
|---|---|---|
| questionnaireStandardized questionnaires assessing regret related to pediatric management, quality of life, sexual function, and psychological outcomes. | Other | – |
Primary outcome
Regret related to pediatric management
Time frame: At study inclusion (baseline)
Regret related to pediatric management assessed by the Decision Regret Scale (DRS)
4 secondary outcomes
Quality of life
Time frame: at study inclusion (baseline)
Sexual function
Time frame: at study inclusion (baseline)
Symptoms of anxiety and depression
Time frame: at study inclusion
Adaptation of hormonal treatment from adolescence to adulthood
Time frame: at study inclusion (baseline)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- 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.
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 Classic Congenital Adrenal Hyperplasia and 21-Hydroxylase Deficiency, run by University Hospital, Lille 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 5 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: looking for participants now, as of the sponsor's last update on 24 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sophie CATTEAU JONARD, PhD (+33 3 20 44 63 09, Sophie.catteau@chu-lille.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Regret related to pediatric management (time frame: At study inclusion (baseline)). 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 24 Aug 2026.