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Department of Environmental Health

Fernald Community Cohort

Research Opportunities

Research Opportunities Using the Fernald Community Cohort

Funding for the physical examinations and testing component of the Fernald settlement ended in November, 2008, but the data and biospecimens collected during the 18 year tenure of the FMMP continue to be available to researchers for epidemiological studies. On January 13, 2010 the Special Master of the Fernald Settlement Fund entered into an agreement to transfer the FMMP database and biospecimen collection to the University of Cincinnati for the purpose of maintaining the database and biospecimen collection for use in epidemiological and genetic  research. The Fernald Medical Monitoring Program (FMMP) became the Fernald Community Cohort (FCC).

The Fernald Community Cohort has an established procedure for applications for access to data and biospecimens for use for research studies. The University of Cincinnati and the FCC Advisory group are both very much in favor of the samples (and data) being used for research. The Fernald Medical Monitoring Program required that participants sign a consent at the time of each examination, and has IRB approval (04-02-07-05-EE and 2012-3745), including approval for use of data and biospecimens for future research.

The members of the Fernald Community Cohort (FCC) were participants in the Fernald Medical Monitoring Program (FMMP). Members of the cohort received medical screening examinations every two or three years, over an 18 year period, from 1990 to 2008 when the program ended. Questionnaires were administrated yearly. Medical history on this population is extremely well characterized, verified, and all cancer diagnoses have been validated with medical records. Extensive disease risk factor information has been collected, and for most information, prior to disease diagnosis. (The menu on the left hand side of this page directs you to extensive descriptions of the data and codes.) The FCC has repeat measures of clinical laboratory tests on all cohort members. Most of the clinical information is coded and all data are stored in a series of related SAS databases. The cohort contains members of multi-generational families, and a family relationship database exists, linking members in the cohort to their other family members.  

Freezer Open

Blood and urine specimens were collected at enrollment and at various intervals throughout follow-up and were cryo-preserved in -80 degree C freezers.  At the first examination three 1-ml aliquots of whole blood, plasma, serum, urine and urine with buffer were obtained from each participant (15 aliquots per person) for future analyses. Additional whole blood and serum was obtained in 1996-1997 and 2006-2008. To date, only a small proportion of the over 160,000 specimens have been used for research.

As of September 30, 2016, we have 159,645 banked biospecimens in six -80 C freezers.

Number and volume of aliquots banked per person at different times, and total number of aliquots.

Examination/Year Blood Serum Plasma Urine (unbuffered) Urine (buffered)
 Initial exam
(mostly 1991-1994)
 3 1ml  3 1ml  3 1ml  3 1ml  3 1ml
 Second exam    2 1ml  2 1ml    
 2006
(just those with cancer diagnoses)
 3 1.5ml        
 2007-2008 exam
(urine only on a portion of the cohort)
 3 1.5ml   3 1.5ml    3 1.5ml  3 1.5ml
           
Total aliquots remaining in freezer1
(not distributed)
 32,990  48,139  36,179  21,017  20,940

1An additional 380 DNA aliquots are banked in the freezers

index plot

This cohort is appropriate to use for studies that are not related to radiation or uranium exposure. Much of the cohort never received exposure beyond the background exposure received by the general population. Extensive uranium dose reconstruction using methods developed by the CDC demonstrate that over 60% of the cohort had such minimal exposure to uranium and radon that their cumulative ionizing radiation exposure was less than 3.2% over lifetime background levels. Because the cohort contains a large group of individuals without exposure, the data and biospecimens of the cohort can be used to address a wide range of research questions, both non-exposure related and exposure related.

 

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Use of the Fernald Community Cohort Data and Biospecimens

The availability of the data and biospecimens of the Fernald Community Cohort for future research studies has been communicated by presentations at various scientific meetings and through listing on ClinicalTrials.gov.

Research investigators interested in using the FCC database and samples for health-related research may apply for Access to Data and/or Biological Specimens. If approved by the Research Director, with the advice of the Fernald Community Cohort Advisory Committee, data files from the FCC database or archived samples (frozen whole blood, serum, plasma and urine) may be distributed to qualified researchers.

Any individual or group desiring access to the FCC database or archived samples for purpose of conducting a research study must first submit an application to the FCC Research Director, Dr. Susan M. Pinney, who, in turn, will first obtain input from the Fernald Community Cohort Advisory Committee. Pdf files of the FMMP Access to Data and Specimens Policy are below.

 

 

 

Clinical Trials gov

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