Glioblastoma Platelet Activation Study | NCT02887417

Studies
Glioblastoma Platelet Activation Study

NCT02887417

Sponsor

University Medicine Greifswald

Status

Completed

Last Update Posted

Aug 1, 2017Actual

Enrollment

21Actual

Phase

Not provided

Conditions

Glioblastoma
Circulating Platelet-monocyte Conjugates

Interventions

Not provided

Countries

Germany

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

Jul 2017

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

Jan 2016

Primary Completion Date

Oct 2016Actual

Completion Date

Dec 2016Actual

First Submitted Date

Aug 18, 2016

First Submission Date that Met QC Criteria

Aug 29, 2016

First Posted Date

Sep 2, 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

Jul 31, 2017

Last Update Posted Date

Aug 1, 2017Actual

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

Glioblastoma face an increased risk of venous or arterial thromboembolism. Furthermore, the most frequent immune cells in glioblastoma are tumor associated macrophages, which find theirself in an anti-inflammatory (M2) phenotype.

Increased conjugates between circulating platelets and monocytes reflect an pro-inflammatory status.

Detailed Description

Increased conjugates between circulating platelets and monocytes reflect an pro-inflammatory status.

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

21Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
patients		glioblastoma patients
controls		healthy controls

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mean P-selectine expression in all platelets		01/ 2016 - 10/ 2016
Mean CD63 expression in all platelets		01/ 2016 - 10/ 2016
Mean CD40 Expression in all platelets		01/ 2016 - 10/ 2016
Mean platelet-monocyte-conjugate formation in the monocyte population		01/ 2016 - 10/ 2016

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

MR-morphological suspicion for glioblastoma
informed consent

Exclusion Criteria:

no informed consent

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

consecutive patients with suspicious for glioblastoma

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Neurosurgery		Greifswald		17475	Germany

Condition Browse Module

MeSH Terms

ID	Term
D005909	Glioblastoma

Ancestor Terms

ID	Term
D001254	Astrocytoma
D005910	Glioma
D018302	Neoplasms, Neuroepithelial
D017599	Neuroectodermal Tumors

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Browse Branches

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