Different Methods of Measuring Sex Hormone Levels in Blood Samples From Healthy Volunteers - Full Text View

Sponsored by:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00899925

Purpose

RATIONALE: Finding a better way to measure levels of sex hormones in the blood may help doctors monitor cancer in future patients.

PURPOSE: This study is looking at different ways of measuring sex hormones in blood samples from healthy participants to see which one is the best.

Condition	Intervention
Healthy, no Evidence of Disease	Other: chromatography Other: diagnostic laboratory biomarker analysis Other: immunological diagnostic method Other: liquid chromatography Other: mass spectrometry

Study Type:	Observational
Official Title:	Reproducibility of Serum Sex Steroid Measurement: A Proof of Performance Study

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Reproducibility of sex steroid assays including gas chromatography-mass spectrometry (GC-MS) and liquid chromatography (LC) -MS-MS [ Designated as safety issue: No ]
Compare results of GC-MS and LC-MS-MS with those of radioimmunoassay [ Designated as safety issue: No ]

Estimated Enrollment:

60

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	20 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00899925

Sponsors and Collaborators

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Ann Hsing, MD

National Cancer Institute (NCI)

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000566368, NCI-03-C-N274
Study First Received:	May 9, 2009
Last Updated:	May 16, 2009
ClinicalTrials.gov Identifier:	NCT00899925 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

healthy, no evidence of disease

Study placed in the following topic categories:

Healthy
Hormones

ClinicalTrials.gov processed this record on September 11, 2009