ClinicalTrials.gov record NCT07253454
Combined Use of Machine Learning and Metabolomics to Improve the Diagnosis and Management of Hyperandrogenism
Combined Use of Machine Learning and Metabolomics to Improve the Diagnosis and Management of Hyperandrogenism
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This observational study collects medical-record data and metabolomics information to study hyperandrogenism in female patients. Researchers will use machine learning to try to distinguish different causes and compare patients whose tests were normal (control group). Data from a five-year period will be analyzed; no treatments are assigned.
What it is studying. The study tests whether machine learning methods combined with metabolomics data can distinguish between different causes of hyperandrogenism. Secondary questions include whether metabolomics can help guide patient management, whether metabolomics can predict CYP21A2 genotyping results, and how anti-androgen hormone therapy affects the model's predictive performance.
What the researchers hope to learn. To evaluate whether combining machine learning and metabolomics can help tell apart different causes of hyperandrogenism, to explore metabolomics’ role in patient management, to assess prediction of CYP21A2 genotype, and to study the effect of anti-androgen therapy on model predictions.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
Hyperandrogenism is a common reason for consultation, the causes of which can range from common conditions (PCOS) to rarer conditions with major genetic implications (NC21OHD). It is characterized by elevated levels of circulating androgens, mainly testosterone. This excess of androgens usually manifests clinically as increased male-pattern hair growth and, less specifically, acne and alopecia. Its prevalence is estimated at between 6 and 12% in women of reproductive age, and its incidence is increasing. It is also responsible for infertility. As a reminder, infertility is a major public health issue and affects more and more couples around the world. The investigators therefore wish to develop innovative tools to improve the diagnosis and management of hyperandrogenism
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Other
- data collection
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
Inclusion criteria
- Patients of childbearing age (16 to 45 years old)
- Suffering from hyperandrogenism
- Established etiological diagnosis with elimination of differential diagnoses
- Informed and not opposed to the collection of their data for the purposes of the study
Exclusion criteria
- Pregnancy
- Patients under legal protection measures
Study description and what participation involves
The study's detailed description, as published on ClinicalTrials.gov.
Detailed description from the registry
Hyperandrogenism is a common reason for consultation, the causes of which can range from common conditions (PCOS) to rarer conditions with major genetic implications (NC21OHD). It is characterized by elevated levels of circulating androgens, mainly testosterone. This excess of androgens usually manifests clinically as increased male-pattern hair growth and, less specifically, acne and alopecia. Its prevalence is estimated at between 6 and 12% in women of reproductive age, and its incidence is increasing. It is also responsible for infertility. As a reminder, infertility is a major public health issue and affects more and more couples around the world. The investigators therefore wish to develop innovative tools to improve the diagnosis and management of hyperandrogenism
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
Participating centers will select and review medical records that meet eligibility. The study involves collection of data from those records covering a period of 5 years; no additional procedures, visits, or invasive tests are described in the registry. Records for a control group (people tested for symptoms but with normal results) will also be collected. The registry requires that patients be informed and not oppose use of their data.
How the study is structured. An observational, cross-sectional cohort study using retrospective data collection. Participating centers will gather medical-record data (covering a five-year period) and associated metabolomics information. Records from people with hyperandrogenism will be compared with a control group whose symptoms were investigated but had normal test results. Data will be analyzed with machine-learning techniques; there is no experimental treatment or randomization.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
- The registry says recruitment has not started. When is it expected to open, and can I register interest now?
- No sites are listed on the registry yet. Where will the study take place?
- Which of the eligibility criteria would need to be checked with tests before I could join?
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Important dates
- Study start
- January 2026 (estimated)
- Primary completion
- December 2040 (estimated)
- Study completion
- December 2040 (estimated)
- Target enrollment
- 800 participants (estimated)
- Last updated on registry
- Dec 4, 2025
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Anne Pr BACHELOT 📞 0033 01 42 16 02 46 ✉ anne.bachelot@aphp.fr
Participating sites
Study locations have not been posted on ClinicalTrials.gov yet. This study is not yet recruiting, so sites may be added when recruitment begins. The central study contact above may be able to tell you about planned sites.
Terms used on this page · explanations by MedicalUpdates.ai
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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