SCCOR Minorities Observational Study | NCT02898272

Studies
SCCOR Minorities Observational Study

NCT02898272

Sponsor

University of Pittsburgh

Status

Completed

Last Update Posted

May 9, 2023Actual

Enrollment

40Actual

Phase

Not provided

Conditions

Pulmonary Disease, Chronic Obstructive
Emphysema

Interventions

Not provided

Countries

Not provided

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

May 2023

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

Aug 2016

Primary Completion Date

Mar 31, 2023Actual

Completion Date

Mar 31, 2023Actual

First Submitted Date

Aug 15, 2016

First Submission Date that Met QC Criteria

Sep 7, 2016

First Posted Date

Sep 13, 2016Estimated

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

May 8, 2023

Last Update Posted Date

May 9, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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 SCCOR Minorities study will recruit minority participants from the COPDGene cohort, in whom the University of Pittsburgh has already obtained baseline and five year data, in order to enhance bone mineral density and vascular function data collection from minority smokers. Dual X-ray absorptiometry (DXA) scans will be obtained to measure bone mineral density. Non-invasive vascular studies will be performed to measure endothelial function. Questionnaires regarding symptoms and activity levels will be administered and a blood sample will be obtained in participants in which blood samples are not already available from the COPDGene study visits.

Detailed Description

Not provided

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

40Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Dual Xray Absorptiometry measurement of lumbar spine and hip bone mineral density.		As this is a cross-sectional collection of data, the outcome will be measured once at the first and only study visit.

Secondary Outcomes

Measure	Description	Time Frame
Measurement of carotid artery intimal thickness with ultrasound		As this is a cross-sectional collection of data, the outcome will be measured once at the first and only study visit.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

African American male and female subjects participating in COPDGene study

Exclusion Criteria:

caucasians
pregnant women

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

- African American male and female subjects participating in COPDGene study

Sampling Method

Non-Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D029424	Pulmonary Disease, Chronic Obstructive
D004646	Emphysema

Ancestor Terms

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease

Browse Leaves

Not provided

Browse Branches

Not provided