Condition: Androgen Insensitivity Syndrome · Metabolic Parameters in AIS, CAIS, PAIS and MAIS · Tumor Formation in AIS, CAIS, PAIS and MAIS · Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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 8-99 with AIS and their adult relatives Design: Participants will go through a series of study procedures for data and sp…
This description comes directly from the study's public registry record.
Veronica Gomez-Lobo, M.D. · (301) 435-7567 · veronica.gomez-lobo@nih.gov
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| National Institutes of Health Clinical Center | Bethesda, Maryland, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT04708431