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El Paso Public Health Biorepository (EPB)

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ClinicalTrials.gov Identifier: NCT03123705
Recruitment Status : Recruiting
First Posted : April 21, 2017
Last Update Posted : October 23, 2018
Sponsor:
Collaborator:
The City of El Paso Department of Public Health
Information provided by (Responsible Party):
Daniel Terreros, Texas Tech University Health Sciences Center, El Paso

Brief Summary:
The prevalence of tooth decay and other oral diseases are often overlooked indicators of overall public health. To improve the understanding of oral health in El Paso, the City of El Paso Health Department has teamed up with Texas Tech University Health Sciences Center at El Paso in a collaborative effort to determine the factors that contribute to poor oral health, and lead to cavities and periodontitis. The team will collect saliva, oral debris, leftover teeth and plaque from children and young adults to study oral infections, markers of inflammation, genetic, epigenetic and other contributors to oral illnesses in Hispanics. Samples also will be stored for future investigations. This joint effort will provide a better picture of oral health in El Paso, and will define a framework for prevention, earlier diagnosis, and better treatment.

Condition or disease
Oral Disease Inflammation of Mouth Viral Disease

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Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: TTUHSC El Paso Public Health Biorepository (Research Core Laboratories Dental Biorepository)
Actual Study Start Date : May 26, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : May 31, 2020



Primary Outcome Measures :
  1. Creation of tissue, blood and saliva Biorepository [ Time Frame: Through study completion, an average of 3 years ]
    Tissue, blood and saliva will be collected from dental patients to be stored for research

  2. The study of oral bacterial and viruses [ Time Frame: Through study completion, an average of 3 years ]
    Samples will be analyzed to determine if bacteria and viruses play a role in oral health

  3. Inflammatory Markers [ Time Frame: Through study completion, an average of 3 years ]
    Samples will be tested for inflammatory markers


Biospecimen Retention:   Samples With DNA
Saliva and blood samples; bacterial and human DNA will be stored


Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Male and female patients between the ages of 10-21.
Criteria

Inclusion Criteria:

  • Uninsured, medicaid and Title V seen at the City of El Paso Dental or pediatric Clinics ages 10-21
  • Lean, overweight and obese male and female children and young adults living in El Paso County
  • Healthy children and patients that are likely to be seen in the clinics within the predetermined follow-up time of 6 months

Exclusion Criteria:

  • Patients under 10 years of age and over 21 years of age.

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 ClinicalTrials.gov identifier (NCT number): NCT03123705


Contacts
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Contact: Daniel A Terreros, M.D. Ph.D (915) 215-4288 daniel.terreros@ttuhsc.edu
Contact: Giannina Heredia, B.S. (915) 215-4290 giannina.heredia@ttuhsc.edu

Locations
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United States, Texas
Texas Tech University Health Sciences Center El Paso Recruiting
El Paso, Texas, United States, 79905
Contact: Daniel A Terreros, M    915-215-4288    daniel.terreros@ttuhsc.edu   
Sponsors and Collaborators
Texas Tech University Health Sciences Center, El Paso
The City of El Paso Department of Public Health
Investigators
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Principal Investigator: Daniel A Terreros, M.D. Ph.D Texas Tech University Health Sciences Center, El Paso

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Responsible Party: Daniel Terreros, Professor Pathology PL Foster Medical and Graduate Schools, Texas Tech University Health Sciences Center, El Paso
ClinicalTrials.gov Identifier: NCT03123705     History of Changes
Other Study ID Numbers: E16076
First Posted: April 21, 2017    Key Record Dates
Last Update Posted: October 23, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Identifiable information i.e. GPS address will be available to health authorities under the Common Rule mandate.

De-identified information and tissue and body fluid samples will be made available to collaborating academic institutions through material transfer agreements.

Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Request for materials and samples will be made available to potential collaborators and for complementary research starting 2019 or when ever the research observations are published in a peer reviewed journal.
Access Criteria: Collaborating Institutions in the understanding of disease processes in Hispanic populations

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Inflammation
Virus Diseases
Mouth Diseases
Stomatitis
Pathologic Processes
Stomatognathic Diseases