El Paso Public Health Biorepository | NCT03123705

Studies
El Paso Public Health Biorepository

NCT03123705

Sponsor

Texas Tech University Health Sciences Center, El Paso

Status

Completed

Last Update Posted

Oct 28, 2019Actual

Enrollment

90Actual

Phase

Not provided

Conditions

Oral Disease
Bacterial Disease

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 26, 2017Actual

Primary Completion Date

Aug 31, 2019Actual

Completion Date

Sep 30, 2019Actual

First Submitted Date

Apr 13, 2017

First Submission Date that Met QC Criteria

Apr 18, 2017

First Posted Date

Apr 21, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 24, 2019

Last Update Posted Date

Oct 28, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Peter Rotwein, Professor, Texas Tech University Health Sciences Center, El PasoPrincipal Investigator

Lead Sponsor

Texas Tech University Health Sciences Center, El PasoOTHER

Collaborators

Name	Class
The City of El Paso Department of Public Health	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The prevalence of tooth decay and other oral diseases are overlooked indicators of overall public health. To improve the understanding of oral health in El Paso, the City of El Paso Health Department will work with Texas Tech University Health Sciences Center at El Paso to determine factors that contribute to poor oral health, and lead to cavities and periodontitis. The team will collect saliva from children and young adults to study oral infections, markers of inflammation, and other contributors to oral illnesses in Mexican-American individuals.

Detailed Description

As per summary above.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

90Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Creation of saliva bio-repository	Saliva will be collected from dental patients to be stored for research	Through study completion, an average of 3 years
The study of oral bacteria	DNA of samples will be analyzed to determine if bacteria play a role in oral health	Through study completion, an average of 3 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Individuals seen at the City of El Paso dental or pediatric clinics ages 10-21
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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

10 Years

Maximum Age

21 Years

Standard Ages

ChildAdult

Study Population

Male and female patients between the ages of 10-21.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Peter S Rotwein, M.D.	Texas Tech University Health Sciences Center, El Paso	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Texas Tech University Health Sciences Center El Paso		El Paso	Texas	79905	United States

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

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

Types

Study Protocol

Time Frame

Request for materials should be made after research observations are published in a peer reviewed journal.

Access Criteria

Institutions studying disease processes in Hispanic populations

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009059	Mouth Diseases
D001424	Bacterial Infections

Ancestor Terms

ID	Term
D009057	Stomatognathic Diseases
D001423	Bacterial Infections and Mycoses
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided