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NCT04708431 · ClinicalTrials.gov registry record
Androgen Receptor, Implications for Health and Wellbeing: Natural History Study of Individuals With Androgen Insensitivity
A clinical trial of Androgen Insensitivity Syndrome and Metabolic Parameters in AIS, CAIS, PAIS and MAIS, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
- Recruiting
- Registry status
- 650
- Enrollment target
- 1
- Study location
NCT04708431: Recruiting study of Androgen Insensitivity Syndrome and Metabolic Parameters in AIS, CAIS, PAIS and MAIS, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
NCT04708431 is a study of Androgen Insensitivity Syndrome and Metabolic Parameters in AIS, CAIS, PAIS and MAIS that is actively recruiting participants, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The registered enrollment target is 650 participants. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04708431, a study of Androgen Insensitivity Syndrome and Metabolic Parameters in AIS, CAIS, PAIS and MAIS, is actively recruiting participants, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
- RECRUITING
- Registry status
- 650 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: Androgen effects in humans are usually (but not always) mediated by the androgen receptor which is coded for by the androgen receptor gene (AR gene). Androgen Insensitivity Syndrome (AIS) is a rare condition in which the body cannot sense the male hormones in the blood or tissue. Both women and men can be affected by AIS. Researchers want to learn more about the health of people with AIS over time. With a natural history study in individuals with AIS, data and tests may provide information regarding health risks (including the risks and benefits of gonadectomy and best ways to monitor for tumor) and optimal management of individuals with AIS as well as elucidate the role of the androgen receptor in human health. This study does not involve any interventions and we can provide clinical care while collecting data. Objective: The objective of this natural history study is to describe and define a comprehensive phenotype (characteristic) of patients with AIS based on confirmed androgen receptor (AR) gene difference. We will evaluate hormones, bone density and markers, cardiovascular and metabolic parameters, as well as quality of life and tumor formation risk and evaluation. The purpose is to obtain a better understanding of the overall health issues that people with AIS may have through the study procedures listed. Eligibility: People ages 0-99 with AIS and their adult relatives Design: Participants will go through a series of study procedures for data and specimen collection. This will be done to understand how AIS affects individuals since the androgen receptor is found in many tissues in the body including skin, bone, muscle, and the neurologic, immune and metabolic systems. All tests will be performed by skilled and trained study professionals. Participants will be screened with: Medical history Physical exam Medical record review Lab tests. Participants will have physical exams. Their body measurements will be taken. They will have blood
Primary Outcome
Primary Objectives: To define and describe a comprehensive phenotype of patients with androgen insensitivity (based on confirmed androgen receptor (AR) gene difference), including hormonal, metabolic, immunologic, and cardiovascular aspects of the disease, as well as quality life and tumor formation risk and evaluation
Conditions Studied
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 650 participants |
| Start Date | 2021-04-29 |
| Est. Completion | 2040-02-01 |
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)305 total trials
What NCT04708431 shows while recruiting
NCT04708431 is an observational study that tracks outcomes without assigning an intervention. The registered 650 participants enrollment target is mid-sized for trials with a published cap.
The record links to 4 conditions, with Androgen Insensitivity Syndrome appearing as the primary indexed condition, and to 0 interventions.
NCT04708431 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT04708431 about?
NCT04708431 is a clinical study titled "Androgen Receptor, Implications for Health and Wellbeing: Natural History Study of Individuals With Androgen Insensitivity". Background: Androgen effects in humans are usually (but not always) mediated by the androgen receptor which is coded for by the androgen receptor gene (AR gene). Androgen Insensitivity Syndrome (AIS) is a rare condition in which the body cannot sense the male hormones in the blood or tissue. Both w...
What is the current status of trial NCT04708431?
This trial is currently recruiting. The enrollment target is 650 participants. The study started on 2021-04-29. Estimated completion is 2040-02-01.
What conditions does trial NCT04708431 study?
This clinical trial studies the following conditions: Androgen Insensitivity Syndrome, Metabolic Parameters in AIS, CAIS, PAIS and MAIS, Tumor Formation in AIS, CAIS, PAIS and MAIS, Sexual Function AIS, CAIS, PAIS and MAIS.
Who is sponsoring clinical trial NCT04708431?
This trial is sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which has 305 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04708431 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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