Exosome Proteomics to Detect EPO | NCT03700515

Studies
Exosome Proteomics to Detect EPO

NCT03700515

Sponsor

Morten Hostrup, PhD

Status

Unknown status

Last Update Posted

Sep 25, 2019Actual

Enrollment

72Estimated

Phase

Not Applicable

Conditions

Healthy

Interventions

Erythropoietin
Placebo

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

Sep 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 4, 2019Actual

Primary Completion Date

Oct 15, 2020Estimated

Completion Date

Oct 15, 2020Estimated

First Submitted Date

Sep 27, 2018

First Submission Date that Met QC Criteria

Oct 5, 2018

First Posted Date

Oct 9, 2018Actual

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

Sep 24, 2019

Last Update Posted Date

Sep 25, 2019Actual

Name	Class
University of Tasmania	OTHER

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

The role of exosomes in cell signalling has only recently been appreciated and is a hugely exciting and rapidly growing area, and combined with LC-MS/MS proteomics, can overcome traditional barriers to proteomics in doping applications. To our knowledge, no research has yet been undertaken to explore whether the highly promising combination of exosome proteomics has utility for rhEPO detection. The applications are extensive; the diagnostic value of differentially regulated proteins could be further validated against the existing IEF EPO WADA accredited tests using samples collected during this study, used to study altitude hypoxia versus exogenous EPO administration (WADA current targeted research 2017), investigated as a platform approach to ESA and HIF agents more generally, as well as facilitate development of direct ELISA high throughput tests.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

72Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	Saline infusion	Drug: Placebo
EPO	Experimental	Erythropoetin infusion (9 IU/kg)	Drug: Erythropoietin
EPO II	Experimental	Erythropoetin infusion (20 IU/kg)	Drug: Erythropoietin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Erythropoietin	Drug	Subjects receive weekly infusions of EPO	EPO EPO II

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Blood proteome enrichment pathway analysis in GO annotation	Change in enrichment (measured in blood and assessed using GO annotation)	At baseline and after week 3 of treatment

Secondary Outcomes

Measure	Description	Time Frame
Blood markers of iron	Change in blood markers of iron homeostasis	At baseline and after week 3 of treatment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

VO2max of at least 55+/-2 for men and 50+/-2 for women
BMI between 18 and 27
Resting hematocrit of less than 46%

Exclusion Criteria:

Chronic disease deemed by the medical doctor to affect the outcome
Competitive athlete subject to doping control
Use of other prescription medicine deemed by the medical doctor to interact with the study drug
Allergy or otherwise unacceptable side effects toward the study drug
Smoker
Pregnancy

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
August Krogh Building	Recruiting	Copenhagen			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

Intervention Browse Module

MeSH Terms

ID	Term
D004921	Erythropoietin

Ancestor Terms

ID	Term
D003115	Colony-Stimulating Factors
D006023	Glycoproteins
D006001	Glycoconjugates
D002241	Carbohydrates

Browse Leaves

Not provided

Browse Branches

Not provided