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Reproducibility of Serum Sex Steroid Measurement: A Proof of Performance Study


N/A
20 Years
75 Years
Open (Enrolling)
Both
Healthy, no Evidence of Disease

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Trial Information

Reproducibility of Serum Sex Steroid Measurement: A Proof of Performance Study


OBJECTIVES:

- Evaluate reproducibility of sex steroid assays, including testosterone,
dihydrotestosterone, androstenedione, estrone, estradiol, androstenediol, and
dehydroepiandrosterone (DHEA) by gas chromatography-mass spectrometry (GC-MS) and
androstenediol glucuronide, androsterone glucuronide, DHEA sulfate, and estrone sulfate
by liquid chromatography (LC)-MS-MS.

- Evaluate the reproducibility of the measurement of these steroids and metabolites by
radioimmunoassay (RIA).

- Compare the assay results of GC-MS and LC-MS-MS to those of RIA.

OUTLINE: Participants undergo blood collection for laboratory analysis. Samples are analyzed
by gas chromatography-mass spectrometry (MS), liquid chromatography-MS-MS, and
radioimmunoassay to assess the reproducibility of these assays for measuring sex steroids.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Participants must meet 1 of the following criteria:

- Healthy men 50 to 65 years old; employed by Westat or their related family and
friends

- Premenopausal women 20 to 40 years old

- Postmenopausal women 55 to 75 years old

PATIENT CHARACTERISTICS:

- See Disease Characteristics

PRIOR CONCURRENT THERAPY:

- Not specified

Type of Study:

Observational

Study Design:

N/A

Outcome Measure:

Reproducibility of sex steroid assays including gas chromatography-mass spectrometry (GC-MS) and liquid chromatography (LC) -MS-MS

Safety Issue:

No

Principal Investigator

Ann Hsing, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Institute (NCI)

Authority:

United States: Federal Government

Study ID:

CDR0000566368

NCT ID:

NCT00899925

Start Date:

Completion Date:

Related Keywords:

  • Healthy, no Evidence of Disease
  • healthy, no evidence of disease

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