De-identified Human Tissue Project | NCT06082687

Studies
De-identified Human Tissue Project

NCT06082687

Sponsor

University of Central Florida

Status

Recruiting

Last Update Posted

Dec 6, 2024Actual

Enrollment

1,000,000Estimated

Phase

Not provided

Conditions

Tissue

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

Dec 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 14, 2022Actual

Primary Completion Date

Sep 2027Estimated

Completion Date

Sep 2027Estimated

First Submitted Date

Oct 3, 2023

First Submission Date that Met QC Criteria

Oct 8, 2023

First Posted Date

Oct 13, 2023Actual

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

Dec 3, 2024

Last Update Posted Date

Dec 6, 2024Actual

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Research scientists of the University of Central Florida College of Medicine (COM) and Burnett School of Biomedical Sciences (BSBS) conduct laboratory studies in biomedical and translational medical research for the purpose of understanding human disease and developing innovative methods for diagnosing, measuring, or treating disease or disease symptoms. The key research divisions are cancer, cardiovascular, immunity and pathogenesis, neuroscience, and molecular microbiology.

Detailed Description

The objective of this De-Identified Human Tissue Project is the receipt of de-identified human tissue from medical, surgical, and clinical facilities. The human tissue can be fresh or paraffinized. The human tissue will be picked up by the clinical research team and transferred to research scientists of the University of Central Florida's College of Medicine (COM) or Burnett School of Biomedical Sciences (BSBS) for storage and testing according to their separate IRB-approved or IRB-exempted protocols. These separate protocols cannot be for genetic testing. The Project does not receive human tissue resulting from termination of pregnancy.

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

No data available

No data is available for this block.

Enrollment

1,000,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
de-identified human tissue		This Project will receive de-identified human tissue from cooperating institutions for unknown/undisclosed donors.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Receipt of de-identified human tissue for research	The key research divisions are cancer, cardiovascular, immunity and pathogenesis, neuroscience, and molecular microbiology. Frequently, these studies require human tissue for testing of assays and devices.	5 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion:

- de-identified human tissue from cooperating institutions for unknown/undisclosed donors.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not applicable. This Project will receive de-identified human tissue from cooperating institutions for unknown/undisclosed donors.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Central Florida	Recruiting	Orlando	Florida	32816	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided