- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01891877
Sickle Cell Trait in Football Players
October 17, 2014 updated by: Carroll Flansburg, University of South Florida
Is Sickle Cell Trait as Benign as is Usually Assumed?
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.
Study Overview
Status
Unknown
Conditions
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
Enrollment (Anticipated)
20
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Carroll N Flansburg, in progress
- Phone Number: 8025851054
- Email: cflansbu@mail.usf.edu
Study Contact Backup
- Name: Lorena Madrigal, PhD Anthropology
- Phone Number: 8139742138
- Email: madrigal@usf.edu
Study Locations
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Florida
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Tampa, Florida, United States, 33620
- Recruiting
- University of South Florida
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Principal Investigator:
- Carroll N Flansburg, in progress
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
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.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Current or Former Football Players
Any former or current high school or college football players who carries sickle cell trait.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Poor health outcomes
Time Frame: 30 minutes or less to complete survey and buccal swab
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Any ill health events, such as excessive dehydration, muscle cramping, fatigue, shortness of breath, sickling crises, that can be linked to a sickling event.
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30 minutes or less to complete survey and buccal swab
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Carroll N Flansburg, in progress, University of South Florida
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2012
Primary Completion (ANTICIPATED)
December 1, 2015
Study Completion (ANTICIPATED)
December 1, 2015
Study Registration Dates
First Submitted
June 25, 2013
First Submitted That Met QC Criteria
July 2, 2013
First Posted (ESTIMATE)
July 3, 2013
Study Record Updates
Last Update Posted (ESTIMATE)
October 20, 2014
Last Update Submitted That Met QC Criteria
October 17, 2014
Last Verified
October 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SCT in Football
- NCAA (OTHER: National Collegiate Athletic Association)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Sickle Cell Trait
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National Heart, Lung, and Blood Institute (NHLBI)RecruitingSickle Cell Disease | Sickle Cell TraitUnited States
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University of British ColumbiaCompletedSickle Cell Disease | Beta-Thalassemia | Sickle Cell Trait | Sickle Cell-Beta Thalassemia | Sickle Cell-SS DiseaseCanada, Nepal
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National Institute of Diabetes and Digestive and...RecruitingSickle Cell Disease | Sickle Cell Anemia | Sickle Cell TraitUnited States
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University of FloridaNational Human Genome Research Institute (NHGRI)RecruitingSickle Cell Disease | Sickle Cell TraitUnited States
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Hospices Civils de LyonRecruitingSickle Cell Disease | DrepanocytosisFrance
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Hanane EL KENZCompletedSickle Cell Disease | Sickle Cell TraitBelgium
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University of RegensburgRecruitingSickle Cell Disease | Sickle Cell Anemia | Sickle Cell Disorders | HbS Disease | Hemoglobin S Disease | Sickling Disorder Due to Hemoglobin SGermany, Austria
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HemaQuest Pharmaceuticals Inc.TerminatedSickle Cell Disease | Sickle Cell Anemia | Sickle Cell Disorders | Hemoglobin S Disease | Sickling Disorder Due to Hemoglobin SUnited States, Lebanon, Egypt, Canada, Jamaica
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HemaQuest Pharmaceuticals Inc.CompletedSickle Cell Disease | Sickle Cell Anemia | Sickle Cell Disorders | Hemoglobin S Disease | Sickling Disorder Due to Hemoglobin SUnited States, Lebanon, Canada, Egypt, Jamaica