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Not yet recruiting NCT07253454

Combined Use of Machine Learning and Metabolomics to Improve the Diagnosis and Management of Hyperandrogenism

Observational Hyperandrogenism

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: data collection.
Who it may be relevant to
Registry conditions: Hyperandrogenism. Basic parameters: 16 years — 45 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

Detailed description

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

  • Other data collection
    collection of data from medical records over a period of 5 years

Primary outcome measures

  • Use of machine learning models combined with metabolomics to distinguish between different causes of hyperandrogenism [Time frame: 5 years]
Secondary outcome measures (3)
  • Use of metabolomics to improve the management of patients with hyperandrogenism [Time frame: 5 years]
  • Use of metabolomics to predict CYP21A2 genotyping results [Time frame: 5 years]
  • Study of the impact of anti-androgenic hormone therapy on the predictive capabilities of the model [Time frame: 5 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07253454 · APHP251139

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗