CLINICAL CENTERS FOR ETIOLOGY OF SARCOIDOSIS:  A CASE CONTROL STUDY

NIH GUIDE, Volume 23, Number 33, September 16, 1994



RFP AVAILABLE:  NHLBI-HR-94-21



P.T.





Keywords:



National Heart, Lung, and Blood Institute



The overall objective of this program is to support a six year

multi-center case-control study on the potential etiologic factors for

sarcoidosis.  The program will be conducted in three Phases.  Phase I

(12 Months) will involve protocol development.  Phase II (48 Months)

will involve recruitment and follow-up.  Phase III will involve data

analysis and publication preparation.  This program will consists of a

clinical coordinating center and up to twelve clinical centers.  The

clinical centers will recruit 840 sarcoidosis patients and 1680 control

subjects for study over a four year period.  The cases will also be

followed to gain information on the natural history of this disease

including risk factors for progression of disease.  The protocol to be

developed during Phase I (12 Months) will include a comprehensive

clinical characterization of each participant and determination of

markers of immune responsiveness.  Each clinical center will:  (1)

participate in a cooperative effort with other study investigators to

develop and pretest data reporting forms; (2) establish and train staff

to conduct the study; (3) enroll, interview, and examine 70 patients

(age 21 years or older) with sarcoidosis and, enroll, interview and

collect a blood specimen from 140 matched control subjects over a four

year period; (4) shall have a patient population composition that will

enable the investigators to address factors of gender and ethnicity

that are hypothesized to play a role in the susceptibility to and

expression of sarcoidosis; (5) document the diagnosis of sarcoidosis in

recruited cases by standard clinical criteria, including histologic

evidence of non-caseating granulomatous inflammation and exclusion of

other diseases; (6) perform follow-up assessment on the patients; (7)

assess progression of disease and use of medical care resources; (8)

collect data and forward the data to the Clinical Coordinating Center;

(9) participate in the biological banking system as managed by the

Clinical Coordinating Center in collaboration with the NHLBI-supported

repository; (10) work with other study investigators in the preparation

and writing of reports and manuscripts for publication; (11) interact

with the Clinical Coordinating Center to provide data and related

information necessary for data analysis, and (12) work with other study

investigators in the preparation and writing of reports and manuscripts

for publication.



This announcement is for clinical centers only.  A separate Request for

Proposals (RFP) for the clinical coordinating center will be released

in the near future.  This is not a request for proposals.  It is

anticipated that RFP NHLBI- HR-94-21 will be available on or about

September 15, 1994, with proposals due on or about November 30, 1994.

It is to be noted that award of a contract for this study shall be made

only to offerors who are located in the United States of America.



INQUIRIES



Copies of the RFP may be obtained by submitting a written request along

with three self-addressed mailing labels to:



Joanne C. Deshler

Contracts Operations Branch

National Heart, Lung, and Blood Institute

Westwood Building, Room 654

5333 Westbard Avenue

Bethesda, MD  20892



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