Sickle Cell Trait in Football Players

• ClinicalTrials.gov Identifier: NCT01891877
• Recruitment Status: Unknown
• First Posted: July 3, 2013
• Last Update Posted: October 20, 2014
• Sponsor: University of South Florida
• 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
• 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

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

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