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


N/A
20 Years
75 Years
Not Enrolling
Both
Validation

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Trial Information

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


This evaluation of the reproducibility of serum sex steroid measurements has two components.
The first is the evaluation of reproducibility of laboratory measurements of steroid sex
hormones in men. This is an ancillary study to serve as a quality control (QC) measure for
the ongoing DCEG Prostate Tissue Study (ORSH#: OH99-C-N025; principal investigator: Dr.
Ann Hsing) so that high-quality assays can be chosen to quantify steroids in tissue.
Pending satisfactory performance in serum, we will then evaluate the reproducibility of
tissue hormone measurements by Gas Chromatography-Mass Spectrometry (GC-MS) or by Liquid
Chromatography - Mass Spectrometry-(GC-MS) or by Liquid Chromatography- Mass Spectrometry-
Mass Spectrometry (LC-MS-MS) before incorporating them into the Prostate Tissue Study. The
second component of this study involves evaluation of the reproducibility of sex steroid
hormone measurements in pre- and postmenopausal women. This component, although not part of
the Prostate Tissue Study, is included in this summary because the laboratory, assay
methods, and blood collection procedures used in the female component are identical to those
in the male component and these two components will run in parallel.

The present study will evaluate the reproducibility of serum sex steroid assays using two
different assay methods in different laboratories. Specifically, the study will investigate
assay reproducibility at Dr. Fernand Labrie's laboratory using GC-MS and LC-MSMS and at Dr.
Frank Stanczyk's laboratory using radioimmunoassay (RIA). We propose to collect overnight
fasting blood from 60 healthy subjects (20 men aged 50-65, 20 premonopausal women, and 20
postmenopausal women). Once collected, the blood will be separated and aliquotted into
multiple vials. Serum from each subject will be sent to Dr. Labrie, who will perform CG-MS
or LC-MSMS assays, and to Dr. Stanczyk, who will perform RIA, at four different time
intervals. Subject recruitment and blood collection will be performed by Westat. BBI
Biotech will ship and store the specimens after they have been collected.

Inclusion Criteria


- INCLUSION CRITERIA:

We plan to recruit healthy men aged 50-65 from Westat employees and family and friends of
Westat employees.

One month later we will recruit 20 pre menopausal women (aged 20-40) and 20 post
menopausal women (aged 55-75).

Type of Study:

Observational

Study Design:

N/A

Authority:

United States: Federal Government

Study ID:

999903274

NCT ID:

NCT00340756

Start Date:

August 2003

Completion Date:

February 2011

Related Keywords:

  • Validation
  • GCMS
  • LCMS-MS

Name

Location

National Cancer Institute (NCI), 9000 Rockville PikeBethesda, Maryland  20892