Registry-based Biobank Development and Integrative Physio... | NCT04048993

Studies
Registry-based Biobank Development and Integrative Physiological Analysis

NCT04048993

Sponsor

University of Copenhagen

Status

Recruiting

Last Update Posted

Feb 10, 2025Actual

Enrollment

400Estimated

Phase

Not provided

Conditions

Integrative Human Physiology

Interventions

Biobank development and integrative physiological analysis

Countries

Denmark

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

Feb 2025

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 1, 2019Actual

Primary Completion Date

Aug 10, 2028Estimated

Completion Date

Aug 10, 2028Estimated

First Submitted Date

Aug 5, 2019

First Submission Date that Met QC Criteria

Aug 5, 2019

First Posted Date

Aug 7, 2019Actual

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

Feb 6, 2025

Last Update Posted Date

Feb 10, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

The purpose is to develop a registry-based biobank for integrative physiological analysis based on biological samples (blood, urine, interstitial fluid and muscle) from subjects enrolled in the Section registry, using multivariate and data-mining approaches that includes also clinical and demographic parameters

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

Yes

Target Follow-Up Duration

20 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

400Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Biobank development and integrative physiological analysis	Other	Collection of biological samples (blood, urine, interstitial fluid, adipose tissue and muscle) from subjects enrolled in the Section registry, using multivariate and data-mining approaches that includes also clinical and demographic parameters.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Biobank creation	Collection of biological samples from subjects included in the Section Registry	through study completion, an average of 5 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

able to perform fatiguing exercise

Exclusion Criteria:

severe mental or physical handicap
chronic disease deemed by the M.D. to preclude inclusion
use of prescription medicine deemed by the M.D. to preclude inclusion

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

Human subjects able to perform exercise

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Morten Hostrup, PhD	Contact	24474785		mhostrup@nexs.ku.dk

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Copenhagen	Recruiting	Copenhagen		2100	Denmark

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided