A Evaluation Of Biomarkers Associated With Sports Induced Concussions In College Student Athletes (GATOR)

This study is currently recruiting participants.
Verified February 2012 by Banyan Biomarkers, Inc
Sponsor:
Information provided by (Responsible Party):
Banyan Biomarkers, Inc
ClinicalTrials.gov Identifier:
NCT01472042
First received: September 7, 2011
Last updated: February 13, 2012
Last verified: February 2012

September 7, 2011
February 13, 2012
November 2011
January 2015   (final data collection date for primary outcome measure)
Change in levels of TBI biomarkers from baseline [ Time Frame: 36 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01472042 on ClinicalTrials.gov Archive Site
  • Association of TBI biomarker levels and the Post-Concussion Scale [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Association of TBI biomarker levels and the Standardized Assessment of Concussion [ Time Frame: Baseline (beginning of Sports season), Active Phase (during Sports Season) and End of Sports Season ] [ Designated as safety issue: No ]
  • Association of TBI biomarker levels and the Balance Error Scoring System [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Safety [ Time Frame: Throughout Participation in Study ] [ Designated as safety issue: Yes ]
    The safety endpoints include the cumulative procedure-related adverse event-free survival, and cumulative unanticipated procedure-related adverse events. The only potential risks to patients in this study are those that are normally related to routine blood collection.
  • Assessment of pituitary status and determination of the presence of autoantibodies. [ Time Frame: 36 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Evaluation Of Biomarkers Associated With Sports Induced Concussions In College Student Athletes
A Prospective Evaluation Of Biomarkers Associated With Sports Induced Concussions In College Student Athletes

The purpose of this study is to study the biomarkers in subjects before and after sports-induced traumatic brain injury. The assay will be studied in a sample population of subjects over the age of 18 participating in college sports.

Concussion or mild traumatic brain injury (mTBI) is a condition that affects hundreds of thousands of patients worldwide. It is a biomechanically induced neurological injury, resulting in an alteration of mental status, such as confusion or amnesia, which may or may not involve a loss of consciousness. Concussion affects about 1.6 million to 3.8 million athletes yearly, most commonly in contact sports such as American football and boxing. Early clinical effects of concussion include but are not limited to behavioral changes, impairments of memory and attention, headache, unsteadiness, and rarely, catastrophic severe brain injury (sometimes described as second impact syndrome). More recently, the consequences of repetitive mTBI from multiple concussions in a sports setting are becoming evident. Repeated concussions have been associated with greater severity of symptoms, with longer recovery time, and chronically with earlier onset of age-related memory disturbances and dementia. As a result and in contradistinction to the decades-earlier perception that these injuries were benign, sports medicine professionals are now increasingly being instructed to recognize and manage concussions as soon as they occur. "Understanding the neurobiology of concussion will lead to development and validation of physiological biomarkers of this common injury." These biomarkers (e.g., laboratory tests, imaging, electrophysiology) will then allow for improved detection, better functional assessment and evidence-based return to play recommendations.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Serum Whole Blood and Plasma

Non-Probability Sample

The study will enroll athletes at the University of Florida, Gainesville. Teams considered for inclusion in the study are men's football, women's lacrosse and women's soccer.

  • Traumatic Brain Injury
  • Sports Concussion
  • Sports Injury
Other: Banyan Biomarkers
Biomarkers to detect specific proteins.
  • Sports induced concussion
    Exposure to sports induced concussion
    Intervention: Other: Banyan Biomarkers
  • Routine Athletic Exertion
    Exposure to routine athletic exertion (non-concussion control)
    Intervention: Other: Banyan Biomarkers
  • Other Non-Penetrating Trauma to the Head
    Exposure to other non-penetrating trauma to the head that is witnessed or self-reported
    Intervention: Other: Banyan Biomarkers
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
500
April 2015
January 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • The subject is a University of Florida student athlete on a team participating in the study
  • The Subject is at least 18 years of age at screening (has had their 18th birthday)
  • The Subject is willing to undergo the Informed Consent process prior to enrollment into this study.
  • It is the Principal Investigator's opinion that based on the knowledge of the Subject that the Subject is an appropriate candidate for the study.

Exclusion Criteria:

  • Participating in another clinical study that may affect the results of either study.
  • Venipuncture not feasible (i.e. skin integrity compromised at the venipuncture sites, blood vessel calcification.
  • Not available for the end of season follow-up visit.
  • The Subject is otherwise determined by the Investigator to be medically unsuitable for participation in this study.
Both
18 Years and older
Yes
Contact: Jay Clugston, MD (352) 392-1161
United States
 
NCT01472042
ATO-07
No
Banyan Biomarkers, Inc
Banyan Biomarkers, Inc
Not Provided
Principal Investigator: Jay Clugston, MD University of Florida
Banyan Biomarkers, Inc
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP