Application of Proteome Profiler Antibody Arrays to Find... | NCT03225963

Studies
Application of Proteome Profiler Antibody Arrays to Find Angiogenetic Predictors in Glioma Paitents.

NCT03225963

Sponsor

Taichung Veterans General Hospital

Status

Unknown status

Last Update Posted

Jul 24, 2017Actual

Enrollment

60Estimated

Phase

Not provided

Conditions

Glioblastoma Multiforme
Angiogenesis

Interventions

Chemoradiation with temozolomide

Countries

Taiwan

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

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2015Actual

Primary Completion Date

Jul 31, 2018Estimated

Completion Date

Jul 31, 2018Estimated

First Submitted Date

Jul 19, 2017

First Submission Date that Met QC Criteria

Jul 19, 2017

First Posted Date

Jul 21, 2017Actual

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 20, 2017

Last Update Posted Date

Jul 24, 2017Actual

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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Bevacizumab has become the standard of care of recurrent glioblastoma based on promising clinical trial results with with response rates up to 50% and progression-free survival up to 9 months. In our study, we set to find the serum angiogenesis biomarkers of bevacizumab response.

Detailed Description

Pre-chemoradiation and post-chemoradiation peripheral blood will be obtained to see if there are some angiogenesis biomarker available for prediction of bevacizumab response later.

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

60Estimated

Name	Type	Description	Arm Group Labels	Other Names
Chemoradiation with temozolomide	Radiation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Response of bevacizumab therapy.	Base on the image after bevacizumab therapy (after recurrence)	3 months after bevacizumab therapy

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age older than 20 year old.
Glioblastoma patients who will receive chemoradiation treatment.

Exclusion Criteria:

None

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Obtain peripheral blood pre-chemotherapy, mid-chemoradition and post-chemoraidtion

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Weir Chiang You, M.D. Ph.D.	Contact	886-4-23592525	5602	bigjohnyou@vghtc.gov.tw
Hui Lin Yeh, M.D.	Contact	886-4-23592525	5621	yehl@vghtc.gov.tw

Overall Officials

Name	Affiliation	Role
Weir Chiang You, M.D. Ph.D.	The Institutional Review Board of Taichung Veterans General Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Taichung Veterans General Hospital	Recruiting	Taichung		407	Taiwan

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
12684411	Background	Lamszus K, Ulbricht U, Matschke J, Brockmann MA, Fillbrandt R, Westphal M. Levels of soluble vascular endothelial growth factor (VEGF) receptor 1 in astrocytic tumors and its relation to malignancy, vascularity, and VEGF-A. Clin Cancer Res. 2003 Apr;9(4):1399-405.
20607353	Background	Reynes G, Vila V, Martin M, Parada A, Fleitas T, Reganon E, Martinez-Sales V. Circulating markers of angiogenesis, inflammation, and coagulation in patients with glioblastoma. J Neurooncol. 2011 Mar;102(1):35-41. doi: 10.1007/s11060-010-0290-x. Epub 2010 Jul 6.

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

ID	Term
D059248	Chemoradiotherapy
D000077204	Temozolomide

ID	Term
D003131	Combined Modality Therapy
D013812	Therapeutics
D004358	Drug Therapy
D011878	Radiotherapy