Sickle Cell Trait in Football Players

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

Sickle Cell Trait

Clinical Trial Details

NCT number	NCT01891877
Study type	Observational
Source	University of South Florida
Contact	Carroll N Flansburg, in progress
Phone	8025851054
Email	cflansbu@mail.usf.edu
Status	Recruiting
Phase	N/A
Start date	October 2012
Completion date	December 2015

View Details

See also
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Recruiting	`NCT00012545` - Collection and Storage of Umbilical Cord Stem Cells for Treatment of Sickle Cell Disease
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Completed	`NCT03984500` - A Program to Increase Sickle Cell Trait Knowledge Among Parent of Young Children Identified in Newborn Screening	N/A
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Completed	`NCT00005782` - Mobilization and Handling of Stem Cells for Transplant From Healthy Volunteers With Sickle Cell Trait	Phase 3
Recruiting	`NCT05387564` - Increasing Documentation and Disclosure of Sickle Cell Trait Status: An Implementation Science Approach	N/A
Completed	`NCT03405688` - Transfusion in Sickle Cell Disease: Screening of Sickle Cell Disease Trait in Blood Donors	N/A
Recruiting	`NCT04273022` - Effect of Exercise on Biomarkers in SCT	N/A
Recruiting	`NCT05292781` - CHOICES3: Sickle Cell Disease Parenting CHOICES	N/A
Recruiting	`NCT06071377` - Achieving Understanding of the Natural History of Sickle Cell Trait (AUNT)

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.