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Sickle Cell Trait in Football Players

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ClinicalTrials.gov Identifier: NCT01891877
Recruitment Status : Unknown
Verified October 2014 by Carroll Flansburg, University of South Florida.
Recruitment status was:  Recruiting
First Posted : July 3, 2013
Last Update Posted : October 20, 2014
Sponsor:
Information provided by (Responsible Party):
Carroll Flansburg, University of South Florida

Tracking Information
First Submitted Date June 25, 2013
First Posted Date July 3, 2013
Last Update Posted Date October 20, 2014
Study Start Date October 2012
Estimated Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 2, 2013)
Poor health outcomes [ Time Frame: 30 minutes or less to complete survey and buccal swab ]
Any ill health events, such as excessive dehydration, muscle cramping, fatigue, shortness of breath, sickling crises, that can be linked to a sickling event.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Sickle Cell Trait in Football Players
Official Title Is Sickle Cell Trait as Benign as is Usually Assumed?
Brief Summary This study will look at the five different types of sickle cell and their relation to self-reported ill health to determine whether or not one or two of the sickle cell haplotypes are correlated with worse health outcomes. Participants can do complete the study in under half an hour in the privacy of their own home.
Detailed Description Sickle cell anemia is a disease which results from the inheritance of two hemoglobin S (Hb S) genes. Sickle-cell anemia individuals are referred to as Hb SS patients, and are known to suffer from a variety of life-threatening symptoms. Paramount in the clinical complications of sickle cell patients is the "sickle-cell crisis". If a crisis is not stopped by prompt medical attention, it may result in death. It is becoming increasingly clear that some sickle cell anemic patients have more benign clinical profiles than do others. The genetic reason for such clinical differences has been well determined: although the mutation that changes the "normal" hemoglobin gene is the same in all patients, the genetic material outside of the gene influences how the gene is expressed. This genetic material is referred to as the beta-globin haplotype. Carriers of the sickle cell gene are referred to as Hb AS individuals. Hb AS carriers usually have a normal life free of the clinical problems associated with the disease suffered by sickle cell patients. However, it is becoming increasingly clear that under strenuous situations, some Hb AS carriers do experience heat illness and other life threatening problems while others do not. The purpose of this project is to determine if there is a genetic reason for why some athlete carriers of the sickle cell trait experience heat illness, while others do not. Although the genetic reason for the different clinical outcomes of sickle cell anemic patients is now well understood (different haplotypes result in different disease courses), the possibility that the same haplotypes might be the reason why some sickle cell carriers have worse clinical profiles has never been explored. In this project we will work with a sickle-cell trait registry of athletes, and we will test the haplotypes of Hb AS athletes who have and who have not had heat illness. Our study is the first to attempt to clarify if there is a genetic reason for this occurrence. Total participation time for the study is thirty minutes or less. Information provided by the participant will be analyzed within one year of participation. Deidentified results will be kept for five years, per the University of South Florida's Institutional Review Board protocol, and will be available upon request to the principal investigator. Participants can do complete the study in under half an hour in the privacy of their own home.
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Buccal swabs will be collected from each participant.
Sampling Method Non-Probability Sample
Study Population The study population consists of adult males who currently or formerly played high school or college football and know that they carry sickle cell trait.
Condition Sickle Cell Trait
Intervention Not Provided
Study Groups/Cohorts Current or Former Football Players
Any former or current high school or college football players who carries sickle cell trait.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: July 2, 2013)
20
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2015
Estimated Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • over the age of 18
  • male
  • has previously played or currently plays high school or college football
  • carries sickle cell trait

Exclusion Criteria:

  • under the age of 18
  • female
  • does not carry sickle cell trait
  • has not played or does not play high school or college football
Sex/Gender
Sexes Eligible for Study: Male
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01891877
Other Study ID Numbers SCT in Football
NCAA ( Other Identifier: National Collegiate Athletic Association )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party Carroll Flansburg, University of South Florida
Original Responsible Party Carroll Flansburg, University of South Florida, Graduate Student - Biocultural Anthropolgy and Epidemiology
Current Study Sponsor University of South Florida
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Carroll N Flansburg, in progress University of South Florida
PRS Account University of South Florida
Verification Date October 2014