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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00005664
Other study ID # 000127
Secondary ID 00-CH-0127
Status Terminated
Phase
First received
Last updated
Start date May 22, 2000
Est. completion date December 5, 2019

Study information

Verified date December 5, 2019
Source National Institutes of Health Clinical Center (CC)
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study will evaluate patients with a variety of endocrine disorders in order to 1) learn more about conditions that affect the endocrine glands (glands that secrete hormones) and 2) to train physicians in endocrinology.

Patients of all ages with endocrine-related conditions may be eligible for evaluation under this protocol. Those enrolled may be required to provide blood, saliva, urine or stool samples, and to undergo ultrasound examination of the thyroid gland, ovaries or testes, adrenal glands or other parts of the body. Laboratory or X-ray studies may be done for diagnostic or treatment purposes. In some cases, patients will receive medical or surgical treatment for their disorder. Patients and family members of patients with a hereditary disorder may be asked to provide a blood sample for genetic analysis.


Description:

This protocol is designed to allow inpatient and outpatient evaluation of adults with a variety of endocrine disorders for purposes of research and physician education in our accredited endocrinology training programs. The research-directed evaluations may include blood, saliva, or urine samples, or evaluation tissue that was routinely collected for clinical care. In some patients with endocrine disorders, laboratory or radiological studies will be performed to confirm a diagnosis or to aid in the management of the patient, using standard approaches in current clinical practice. In some cases, the patient will receive medical, radiation or surgical treatment for their disorder. The purpose of these evaluations or treatments to support our clinical training or research missions.


Recruitment information / eligibility

Status Terminated
Enrollment 1588
Est. completion date December 5, 2019
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility - INCLUSION CRITERIA:

- Adult patients of all ages with endocrine-related conditions will be eligible for this protocol.

- Both male and female subjects of all ethnic backgrounds are eligible.

EXCLUSION CRITERIA:

- Unstable patients and patients with severe organ failure that may affect/limit the endocrine work-up and exhaust Clinical Center and/or NICHD resources will be excluded if appropriate. Decisions will be made on a case by case basis by investigators.

- Subjects who are unable to provide informed consent will not be accrued; however, if patients have previously given consent, they will continue to be seen for ongoing clinical care. If they require medically-indicated procedures, we will follow NIH policy regarding obtaining consent from next of kin if they have not indicated a medical decision maker.

- Minor subjects will not be accrued; they will be referred to NICHD protocols or other NIDDK protocols for evaluation of eligibility.

- Prisoners will not be recruited. If a subject becomes incarcerated during the study, s/he may continue to participate so as to not compromise medical care.

Study Design


Locations

Country Name City State
United States National Institutes of Health Clinical Center, 9000 Rockville Pike Bethesda Maryland

Sponsors (1)

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

Country where clinical trial is conducted

United States, 

References & Publications (2)

Raff H, Sharma ST, Nieman LK. Physiological basis for the etiology, diagnosis, and treatment of adrenal disorders: Cushing's syndrome, adrenal insufficiency, and congenital adrenal hyperplasia. Compr Physiol. 2014 Apr;4(2):739-69. doi: 10.1002/cphy.c130035. Review. — View Citation

Sharma ST, Nieman LK. Prolonged remission after long-term treatment with steroidogenesis inhibitors in Cushing's syndrome caused by ectopic ACTH secretion. Eur J Endocrinol. 2012 Mar;166(3):531-6. doi: 10.1530/EJE-11-0949. Epub 2011 Dec 21. — View Citation

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