RECRUITING

Natural History Study of Patients With Excess Androgen

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study will evaluate and gather information in patients with genetic causes of too much androgen (male-like hormone) in order to better understand the effects of too much androgen and describe problems associated with it. Too much androgen in childhood, if untreated, results in rapid growth and early puberty with early cessation of growth and short stature in adulthood. Too much androgen in adulthood may result in infertility, and women may have excess facial hair, acne and a more male-like appearance. Excess androgen may also affect mood and behavior and possibly the secretion of other hormones, such as insulin. Two genetic diseases that result in early childhood androgen excess are congenital adrenal hyperplasia (CAH) and familial male-limited precocious puberty (FMPP). Patients with known or suspected CAH due to 21-hydroxylase deficiency, 11- hydroxylase deficiency, or 3-beta-hydroxysteroid dehydrogenase deficiency and males with known or suspected FMPP may be eligible for this study. Patients with both classic and non-classic CAH are eligible, and patients with androgen excess of unknown cause may be eligible. Participants undergo the following procedures: * Medical history and physical examination. * Fasting blood tests for analysis of hormones, blood chemistries including blood sugar and cardiovascular risk factors such as lipids. * Oral glucose tolerance test for patients with elevated insulin levels. For this test, a catheter (plastic tube) is placed in a vein in the patient's arm. The patient drinks a sugar-containing fluid and blood samples are collected through the catheter at intervals starting with drinking the solution, and then 30, 60 and 120 minutes after drinking the solution. * 24-hour urine collection to measure hormone levels in the urine. * DNA testing for patients with 21-hydroxylase deficiency to help identify the type of genetic mutation responsible for the disease. * X-ray of the left hand to measure bone age in growing children. The x-ray is used to determine how far into puberty the child is and how much growth potential is left in the bones. * A pelvic ultrasound in females and testicular ultrasound in males to evaluate the size and development of the gonads (ovaries in females and testes in males). * Cognitive and psychological tests, including an IQ test and evaluation of memory, achievement and behavior. * Other tests and evaluations based on medical need. The schedule for these procedures varies. In a part of the study involving only patients with CAH, growing children are evaluated twice (once in childhood and once after reaching adult height), and adults are evaluated once. In another part of the study involving patients with CAH and FMPP, growing children are seen twice a year, and adults and children who have reached adult height may be seen annually. Additional visits may be scheduled if medically indicated. In this part of the study, females are asked to keep a record of their periods after their first menstrual cycle. ...

Official Title

Natural History Study of Patients With Excess Androgen

Quick Facts

Study Start:2006-01-02
Study Completion:N/A
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT00250159

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:1 Day to 99 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Males, ages 0 - 99 with known or suspected FMPP or
  2. 2. Patients (males and females, ages 0 - 99) with known or suspected (based on hormonal, clinical and/or genetic testing) CAH of any type.
  3. 3. Patients with excess androgen of unknown etiology or
  4. 4. Relatives of patients in this protocol.
  1. 1. Females with isolated polycystic ovary syndrome. If, following a diagnostic work-up, a patient is determined to have PCOS as the only cause of her hyperandrogenism; she will no longer be followed on this protocol.
  2. 2. Patients with significant non-endocrine medical conditions.
  3. 3. Females who are pregnant at the time of initial enrollment.

Contacts and Locations

Study Contact

Deborah P Merke, M.D.
CONTACT
(301) 496-0718
dmerke@nih.gov

Principal Investigator

Deborah P Merke, M.D.
PRINCIPAL_INVESTIGATOR
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Study Locations (Sites)

Medstar Washington Hospital Center
Washington D.C., District of Columbia, 20010
United States
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
United States

Collaborators and Investigators

Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  • Deborah P Merke, M.D., PRINCIPAL_INVESTIGATOR, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2006-01-02
Study Completion DateN/A

Study Record Updates

Study Start Date2006-01-02
Study Completion DateN/A

Terms related to this study

Keywords Provided by Researchers

  • Congenital Adrenal Hyperplasia (CAH)
  • Familial Male Precocious Puberty (FMPP)
  • 21-Hydroxylase Deficiency
  • Adrenal Insufficiency
  • Natural History
  • Congenital Adrenal Hyperplasia
  • CAH
  • Familial Male Precocious Puberty
  • FMPP

Additional Relevant MeSH Terms

  • Congenital Adrenal Hyperplasia (CAH)
  • Familial Male-Limited Precocious Puberty (FMPP)