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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01472042
Recruitment Status : Completed
First Posted : November 16, 2011
Last Update Posted : July 20, 2016
Information provided by (Responsible Party):
Banyan Biomarkers, Inc

Brief Summary:
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.

Condition or disease Intervention/treatment
Traumatic Brain Injury Sports Concussion Sports Injury Other: Banyan Biomarkers

Detailed Description:
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.

Study Type : Observational
Actual Enrollment : 265 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Evaluation Of Biomarkers Associated With Sports Induced Concussions In College Student Athletes
Study Start Date : November 2011
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Group/Cohort Intervention/treatment
Sports induced concussion
Exposure to sports induced concussion
Other: Banyan Biomarkers
Biomarkers to detect specific proteins.

Routine Athletic Exertion
Exposure to routine athletic exertion (non-concussion control)
Other: Banyan Biomarkers
Biomarkers to detect specific proteins.

Other Non-Penetrating Trauma to the Head
Exposure to other non-penetrating trauma to the head that is witnessed or self-reported
Other: Banyan Biomarkers
Biomarkers to detect specific proteins.

Primary Outcome Measures :
  1. Change in levels of TBI biomarkers from baseline [ Time Frame: 36 months ]

Secondary Outcome Measures :
  1. Association of TBI biomarker levels and the Post-Concussion Scale [ Time Frame: 36 months ]
  2. 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 ]
  3. Association of TBI biomarker levels and the Balance Error Scoring System [ Time Frame: 36 months ]
  4. Safety [ Time Frame: Throughout Participation in Study ]
    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.

  5. Assessment of pituitary status and determination of the presence of autoantibodies. [ Time Frame: 36 months ]

Biospecimen Retention:   Samples Without DNA
Serum Whole Blood and Plasma

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01472042

United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
Sponsors and Collaborators
Banyan Biomarkers, Inc
Principal Investigator: Jay Clugston, MD University of Florida

Responsible Party: Banyan Biomarkers, Inc Identifier: NCT01472042     History of Changes
Other Study ID Numbers: ATO-07
First Posted: November 16, 2011    Key Record Dates
Last Update Posted: July 20, 2016
Last Verified: July 2016

Keywords provided by Banyan Biomarkers, Inc:
Traumatic Brain Injury
Sport Concussion
Head Injury
Sports Injury

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Brain Injuries, Traumatic
Athletic Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System