Fernald Community Cohort -18 Year Observational Study

NCT02295085 | Unknown

• 2 other identifiers: UC2012-3745P30ES006096
• Study Type: observational
• Target: 9,782
• Locations: 1 country
• Sites: 1

Brief Summary

The Fernald Community Cohort consists of the 9782 persons who were enrolled in the Fernald Medical Monitoring Program (FMMP) (1990-2008). The initial comprehensive examination conducted as part of the Fernald Medical Monitoring Program (FMMP) began in the autumn of 1990. The FMMP provided 9,782 initial examinations and 42,775 re-examinations. An extensive computerized database and biospecimen repository was created to provide research resources for future studies. All questionnaire, examination and diagnostic procedure data collected from the FMMP were \[coded by certified medical record coders,\] double entered with verification into a SAS database on site of the examinations. Cryo-preserved blood and urine samples were collected at enrollment and at various intervals throughout follow-up. 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. Specimens have been stored in -80 degree freezers; over 160,000 biospecimens are in the archive. Since 1994, the FCC has had an established procedure for sharing data and biospecimens with qualified researchers. Both the policy and application forms can be found at www.eh.uc.edu/fmmp/research.

Conditions

Cancer; Renal Failure; Diabetes; Cardiovascular Disease

Keywords

Cohort, Prospective, Biospecimens

Outcome Measures

Primary Outcomes (1)

• Incident cancer during the period of cohort follow-up

  Using information from the medical examinations, medical history, assigned ICD codes and diagnosis verification with pathology reports, cancer outcomes are noted in the database with diagnosis date and method of diagnosis verification.

  From enrollment to most recent encounter, average of 12 years, range of 1 day to 18 years

Secondary Outcomes (1)

• Incident renal disease during the period of cohort follow-up

  From enrollment to most recent encounter, average of 12 years, range of 1 day to 18 years

Other Outcomes (1)

• Other incident conditions during the period of cohort followup

  From enrollment to most recent encounter, average of 12 years, range of 1 day to 18 years

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Community members who lived or worked within the five mile radius of the Fernald Uranium Processing Plant boundary for a least 2 consecutive years between January 1, 1952 and December 18, 1984.

You may qualify if:

• Lived or worked within five miles of the Feed Material Processing Center (FMPC) for 2 consecutive years between January 1, 1952 and December 18, 1984. The Fernald Community Cohort (N=9782) includes 5294 female and 4489 male participants; 99.5% are Caucasian. The FMMP has conducted 42,775 medical examinations through the end of 2008.

You may not qualify if:

• Worked at the Feeds Material Processing Center (FMPC)
• Employed by the US Department of Energy or National Lead of Ohio, Inc. (Plant Contractor)

Sponsors & Collaborators

• University of Cincinnati: lead
• National Institute of Environmental Health Sciences (NIEHS): collaborator

Study Sites (1)

University of Cincinnati

Cincinnati, Ohio, 45267-0056, United States

Location

Related Publications (30)

• 3. Fitzpatrick S, Nolan RD, Hallam JS, Pinney, SM. Ecological grief in the Fernald Community Cohort: A pilot study. PLOS Mental Health, 1(1): e0000049. https://doi.org/10.1371/journal.pmen.0000049

  BACKGROUND

• 4. Burcham S, Saul D., Nolan RD., Pinney SM. (2024). Exposure Experiences of Area Residents Near a Chronic Environmental Contamination Site. Ohio Journal of Public Health, 6(1), 1-9. https://doi.org/10.18061/ojph.v6i1.9701

  BACKGROUND

• Rubinstein J, Pinney SM, Xie C, Wang HS. Association of same-day urinary phenol levels and cardiac electrical alterations: analysis of the Fernald Community Cohort. Environ Health. 2024 Sep 19;23(1):76. doi: 10.1186/s12940-024-01114-x.

  PMID: 39300535 BACKGROUND

• Li Y, Xiao X, Li J, Han Y, Cheng C, Fernandes GF, Slewitzke SE, Rosenberg SM, Zhu M, Byun J, Bosse Y, McKay JD, Albanes D, Lam S, Tardon A, Chen C, Bojesen SE, Landi MT, Johansson M, Risch A, Bickeboller H, Wichmann HE, Christiani DC, Rennert G, Arnold SM, Goodman GE, Field JK, Davies MPA, Shete S, Marchand LL, Liu G, Hung RJ, Andrew AS, Kiemeney LA, Sun R, Zienolddiny S, Grankvist K, Johansson M, Caporaso NE, Cox A, Hong YC, Lazarus P, Schabath MB, Aldrich MC, Schwartz AG, Gorlov I, Purrington KS, Yang P, Liu Y, Bailey-Wilson JE, Pinney SM, Mandal D, Willey JC, Gaba C, Brennan P, Xia J, Shen H, Amos CI. Lung Cancer in Ever- and Never-Smokers: Findings from Multi-Population GWAS Studies. Cancer Epidemiol Biomarkers Prev. 2024 Mar 1;33(3):389-399. doi: 10.1158/1055-9965.EPI-23-0613.

  PMID: 38180474 BACKGROUND

• Wones R, Pinney SM, Buckholz JM, Deck-Tebbe C, Freyberg R, Pesce A. Medical monitoring: a beneficial remedy for residents living near an environmental hazard site. J Occup Environ Med. 2009 Dec;51(12):1374-83. doi: 10.1097/JOM.0b013e3181c558f1.

  PMID: 19952785 BACKGROUND

• Blomkalns AL, Gavrila D, Thomas M, Neltner BS, Blanco VM, Benjamin SB, McCormick ML, Stoll LL, Denning GM, Collins SP, Qin Z, Daugherty A, Cassis LA, Thompson RW, Weiss RM, Lindower PD, Pinney SM, Chatterjee T, Weintraub NL. CD14 directs adventitial macrophage precursor recruitment: role in early abdominal aortic aneurysm formation. J Am Heart Assoc. 2013 Mar 8;2(2):e000065. doi: 10.1161/JAHA.112.000065.

  PMID: 23537804 BACKGROUND

• You M, Wang D, Liu P, Vikis H, James M, Lu Y, Wang Y, Wang M, Chen Q, Jia D, Liu Y, Wen W, Yang P, Sun Z, Pinney SM, Zheng W, Shu XO, Long J, Gao YT, Xiang YB, Chow WH, Rothman N, Petersen GM, de Andrade M, Wu Y, Cunningham JM, Wiest JS, Fain PR, Schwartz AG, Girard L, Gazdar A, Gaba C, Rothschild H, Mandal D, Coons T, Lee J, Kupert E, Seminara D, Minna J, Bailey-Wilson JE, Amos CI, Anderson MW. Fine mapping of chromosome 6q23-25 region in familial lung cancer families reveals RGS17 as a likely candidate gene. Clin Cancer Res. 2009 Apr 15;15(8):2666-74. doi: 10.1158/1078-0432.CCR-08-2335. Epub 2009 Apr 7.

  PMID: 19351763 BACKGROUND

• Liu P, Vikis HG, Wang D, Lu Y, Wang Y, Schwartz AG, Pinney SM, Yang P, de Andrade M, Petersen GM, Wiest JS, Fain PR, Gazdar A, Gaba C, Rothschild H, Mandal D, Coons T, Lee J, Kupert E, Seminara D, Minna J, Bailey-Wilson JE, Wu X, Spitz MR, Eisen T, Houlston RS, Amos CI, Anderson MW, You M. Familial aggregation of common sequence variants on 15q24-25.1 in lung cancer. J Natl Cancer Inst. 2008 Sep 17;100(18):1326-30. doi: 10.1093/jnci/djn268. Epub 2008 Sep 9.

  PMID: 18780872 BACKGROUND

• Liu P, Yang P, Wu X, Vikis HG, Lu Y, Wang Y, Schwartz AG, Pinney SM, de Andrade M, Gazdar A, Gaba C, Mandal D, Lee J, Kupert E, Seminara D, Minna J, Bailey-Wilson JE, Spitz M, Amos CI, Anderson MW, You M. A second genetic variant on chromosome 15q24-25.1 associates with lung cancer. Cancer Res. 2010 Apr 15;70(8):3128-35. doi: 10.1158/0008-5472.CAN-09-3583.

  PMID: 20395203 BACKGROUND

• Wagner SE, Burch JB, Bottai M, Pinney SM, Puett R, Porter D, Vena JE, Hebert JR. Hypertension and hematologic parameters in a community near a uranium processing facility. Environ Res. 2010 Nov;110(8):786-97. doi: 10.1016/j.envres.2010.09.004.

  PMID: 20889151 BACKGROUND

• Lu-Fritts PY, Kottyan LC, James JA, Xie C, Buckholz JM, Pinney SM, Harley JB. Association of systemic lupus erythematosus with uranium exposure in a community living near a uranium-processing plant: a nested case-control study. Arthritis Rheumatol. 2014 Nov;66(11):3105-12. doi: 10.1002/art.38786.

  PMID: 25103365 BACKGROUND

• Fang S, Pinney SM, Bailey-Wilson JE, de Andrade MA, Li Y, Kupert E, You M, Schwartz AG, Yang P, Anderson MW, Amos CI. Ordered subset analysis identifies loci influencing lung cancer risk on chromosomes 6q and 12q. Cancer Epidemiol Biomarkers Prev. 2010 Dec;19(12):3157-66. doi: 10.1158/1055-9965.EPI-10-0792. Epub 2010 Oct 28.

  PMID: 21030603 BACKGROUND

• Amos CI, Pinney SM, Li Y, Kupert E, Lee J, de Andrade MA, Yang P, Schwartz AG, Fain PR, Gazdar A, Minna J, Wiest JS, Zeng D, Rothschild H, Mandal D, You M, Coons T, Gaba C, Bailey-Wilson JE, Anderson MW. A susceptibility locus on chromosome 6q greatly increases lung cancer risk among light and never smokers. Cancer Res. 2010 Mar 15;70(6):2359-67. doi: 10.1158/0008-5472.CAN-09-3096. Epub 2010 Mar 9.

  PMID: 20215501 BACKGROUND

• Yaghjyan L, Mahoney MC, Succop P, Wones R, Buckholz J, Pinney SM. Relationship between breast cancer risk factors and mammographic breast density in the Fernald Community Cohort. Br J Cancer. 2012 Feb 28;106(5):996-1003. doi: 10.1038/bjc.2012.1. Epub 2012 Jan 26.

  PMID: 22281662 BACKGROUND

• Liu P, Vikis HG, Lu Y, Wang Y, Schwartz AG, Pinney SM, Yang P, de Andrade M, Gazdar A, Gaba C, Mandal D, Lee J, Kupert E, Seminara D, Minna J, Bailey-Wilson JE, Amos CI, Anderson MW, You M. Cumulative effect of multiple loci on genetic susceptibility to familial lung cancer. Cancer Epidemiol Biomarkers Prev. 2010 Feb;19(2):517-24. doi: 10.1158/1055-9965.EPI-09-0791.

  PMID: 20142248 BACKGROUND

• Christiani DC. Lung cancer genetics: a family affair? Clin Cancer Res. 2009 Apr 15;15(8):2581-2. doi: 10.1158/1078-0432.CCR-09-0003. Epub 2009 Apr 7.

  PMID: 19351746 BACKGROUND

• Xiong D, Wang Y, Kupert E, Simpson C, Pinney SM, Gaba CR, Mandal D, Schwartz AG, Yang P, de Andrade M, Pikielny C, Byun J, Li Y, Stambolian D, Spitz MR, Liu Y, Amos CI, Bailey-Wilson JE, Anderson M, You M. A recurrent mutation in PARK2 is associated with familial lung cancer. Am J Hum Genet. 2015 Feb 5;96(2):301-8. doi: 10.1016/j.ajhg.2014.12.016. Epub 2015 Jan 29.

  PMID: 25640678 BACKGROUND

• Yang S, Pinney SM, Mallick P, Ho SM, Bracken B, Wu T. Impact of Oxidative Stress Biomarkers and Carboxymethyllysine (an Advanced Glycation End Product) on Prostate Cancer: A Prospective Study. Clin Genitourin Cancer. 2015 Oct;13(5):e347-51. doi: 10.1016/j.clgc.2015.04.004. Epub 2015 Apr 18.

  PMID: 25972296 BACKGROUND

• Pinney SM, Biro FM. Letter to the editor re Morollo-Frosh "Communicating results in post-Belmont era biomonitoring studies". Environ Res. 2015 Oct;142:756. doi: 10.1016/j.envres.2015.05.024. Epub 2015 Jun 12. No abstract available.

  PMID: 26076818 BACKGROUND

• Liu Y, Kheradmand F, Davis CF, Scheurer ME, Wheeler D, Tsavachidis S, Armstrong G, Simpson C, Mandal D, Kupert E, Anderson M, You M, Xiong D, Pikielny C, Schwartz AG, Bailey-Wilson J, Gaba C, De Andrade M, Yang P, Pinney SM; Genetic Epidemiology of Lung Cancer Consortium; Amos CI, Spitz MR. Focused Analysis of Exome Sequencing Data for Rare Germline Mutations in Familial and Sporadic Lung Cancer. J Thorac Oncol. 2016 Jan;11(1):52-61. doi: 10.1016/j.jtho.2015.09.015.

  PMID: 26762739 BACKGROUND

• Martin AT, Pinney SM, Xie C, Herrick RL, Bai Y, Buckholz J, Martin VT. Headache Disorders May Be a Risk Factor for the Development of New Onset Hypothyroidism. Headache. 2017 Jan;57(1):21-30. doi: 10.1111/head.12943. Epub 2016 Sep 27.

  PMID: 27676320 BACKGROUND

• Herrick RL, Buckholz J, Biro FM, Calafat AM, Ye X, Xie C, Pinney SM. Polyfluoroalkyl substance exposure in the Mid-Ohio River Valley, 1991-2012. Environ Pollut. 2017 Sep;228:50-60. doi: 10.1016/j.envpol.2017.04.092. Epub 2017 May 13.

  PMID: 28505513 BACKGROUND

• Giannini CM, Herrick RL, Buckholz JM, Daniels AR, Biro FM, Pinney SM. Comprehension and perceptions of study participants upon receiving perfluoroalkyl substance exposure biomarker results. Int J Hyg Environ Health. 2018 Aug;221(7):1040-1046. doi: 10.1016/j.ijheh.2018.07.005. Epub 2018 Jul 17.

  PMID: 30025914 BACKGROUND

• Greene AD, Kendziorski JA, Buckholz JM, Niu L, Xie C, Pinney SM, Burns KA. Elevated serum chemokines are independently associated with both endometriosis and uranium exposure. Reprod Toxicol. 2019 Mar;84:26-31. doi: 10.1016/j.reprotox.2018.12.006. Epub 2018 Dec 21.

  PMID: 30579999 BACKGROUND

• Blake BE, Pinney SM, Hines EP, Fenton SE, Ferguson KK. Associations between longitudinal serum perfluoroalkyl substance (PFAS) levels and measures of thyroid hormone, kidney function, and body mass index in the Fernald Community Cohort. Environ Pollut. 2018 Nov;242(Pt A):894-904. doi: 10.1016/j.envpol.2018.07.042. Epub 2018 Jul 17.

  PMID: 30373035 BACKGROUND

• Byun J, Schwartz AG, Lusk C, Wenzlaff AS, de Andrade M, Mandal D, Gaba C, Yang P, You M, Kupert EY, Anderson MW, Han Y, Li Y, Qian D, Stilp A, Laurie C, Nelson S, Zheng W, Hung RJ, Gaborieau V, Mckay J, Brennan P, Caporaso NE, Landi MT, Wu X, McLaughlin JR, Brhane Y, Bosse Y, Pinney SM, Bailey-Wilson JE, Amos CI. Genome-wide association study of familial lung cancer. Carcinogenesis. 2018 Sep 21;39(9):1135-1140. doi: 10.1093/carcin/bgy080.

  PMID: 29924316 BACKGROUND

• Liu Y, Lusk CM, Cho MH, Silverman EK, Qiao D, Zhang R, Scheurer ME, Kheradmand F, Wheeler DA, Tsavachidis S, Armstrong G, Zhu D, Wistuba II, Chow CB, Behrens C, Pikielny CW, Neslund-Dudas C, Pinney SM, Anderson M, Kupert E, Bailey-Wilson J, Gaba C, Mandal D, You M, de Andrade M, Yang P, Field JK, Liloglou T, Davies M, Lissowska J, Swiatkowska B, Zaridze D, Mukeriya A, Janout V, Holcatova I, Mates D, Milosavljevic S, Scelo G, Brennan P, McKay J, Liu G, Hung RJ, Christiani DC, Schwartz AG, Amos CI, Spitz MR. Rare Variants in Known Susceptibility Loci and Their Contribution to Risk of Lung Cancer. J Thorac Oncol. 2018 Oct;13(10):1483-1495. doi: 10.1016/j.jtho.2018.06.016. Epub 2018 Jul 4.

  PMID: 29981437 BACKGROUND

• Musolf AM, Moiz BA, Sun H, Pikielny CW, Bosse Y, Mandal D, de Andrade M, Gaba C, Yang P, Li Y, You M, Govindan R, Wilson RK, Kupert EY, Anderson MW, Schwartz AG, Pinney SM, Amos CI, Bailey-Wilson JE. Whole Exome Sequencing of Highly Aggregated Lung Cancer Families Reveals Linked Loci for Increased Cancer Risk on Chromosomes 12q, 7p, and 4q. Cancer Epidemiol Biomarkers Prev. 2020 Feb;29(2):434-442. doi: 10.1158/1055-9965.EPI-19-0887. Epub 2019 Dec 11.

  PMID: 31826912 BACKGROUND

• Liu Y, Xia J, McKay J, Tsavachidis S, Xiao X, Spitz MR, Cheng C, Byun J, Hong W, Li Y, Zhu D, Song Z, Rosenberg SM, Scheurer ME, Kheradmand F, Pikielny CW, Lusk CM, Schwartz AG, Wistuba II, Cho MH, Silverman EK, Bailey-Wilson J, Pinney SM, Anderson M, Kupert E, Gaba C, Mandal D, You M, de Andrade M, Yang P, Liloglou T, Davies MPA, Lissowska J, Swiatkowska B, Zaridze D, Mukeria A, Janout V, Holcatova I, Mates D, Stojsic J, Scelo G, Brennan P, Liu G, Field JK, Hung RJ, Christiani DC, Amos CI. Rare deleterious germline variants and risk of lung cancer. NPJ Precis Oncol. 2021 Feb 16;5(1):12. doi: 10.1038/s41698-021-00146-7.

  PMID: 33594163 BACKGROUND

• Musolf AM, Simpson CL, Moiz BA, Pikielny CW, Middlebrooks CD, Mandal D, de Andrade M, Cole MD, Gaba C, Yang P, You M, Li Y, Kupert EY, Anderson MW, Schwartz AG, Pinney SM, Amos CI, Bailey-Wilson JE. Genetic Variation and Recurrent Haplotypes on Chromosome 6q23-25 Risk Locus in Familial Lung Cancer. Cancer Res. 2021 Jun 15;81(12):3162-3173. doi: 10.1158/0008-5472.CAN-20-3196. Epub 2021 Apr 14.

  PMID: 33853833 BACKGROUND

Related Links

• website

Biospecimen

Retention: SAMPLES WITH DNA

160,000 archived biosamples available, drawn from 1990-2008 (whole Bood, Plasma, Serum, Urine, Buffered Urine), extracted DNA. Breast, Renal \& Prostate cancer formalin fixed tissue.

MeSH Terms

Conditions

Neoplasms; Renal Insufficiency; Diabetes Mellitus; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Susan M Pinney, PhD

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Center for Environmental Genetics, Department of Environmental and Public Health Sciences, Program Leader, Cincinnati Cancer Center , UC College of Medicine

Study Record Dates

• First Submitted: October 29, 2014
• First Posted: November 20, 2014
• Study Start: September 1, 1990
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: October 26, 2024

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)