Curcumin Bioavailability in Glioblastoma Patients | NCT01712542

Studies
Curcumin Bioavailability in Glioblastoma Patients

NCT01712542

Sponsor

Johann Wolfgang Goethe University Hospital

Status

Completed

Last Update Posted

Jun 4, 2013Estimated

Enrollment

15Estimated

Phase

Not provided

Conditions

Patient Harboring Glioblastoma That Will Undergo Surgery

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

Jun 2013

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

Oct 2012

Primary Completion Date

May 2013Actual

Completion Date

May 2013Actual

First Submitted Date

Oct 20, 2012

First Submission Date that Met QC Criteria

Oct 22, 2012

First Posted Date

Oct 23, 2012Estimated

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

Jun 1, 2013

Last Update Posted Date

Jun 4, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Stephan Dützmann, M.D., Johann Wolfgang Goethe University HospitalPrincipal Investigator

Lead Sponsor

Johann Wolfgang Goethe University HospitalOTHER

Collaborators

Not provided

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

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

15Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Concentration of Curcumin in Glioblastoma	At the time of surgery	At Tumor resection

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients harboring Glioblastoma
Patient will undergo surgery

Exclusion Criteria:

BMI > 30
Liver and Kidney Function so compromised that medication is prescribed

Accepts Healthy Volunteers

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

Patients harboring Glioblastoma

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Stephan Duetzmann	Goethe University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Neurosurgery, Johann Wolfgang Goethe-University		Frankfurt am Main	Hesse	60528	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20840775	Background	Senft C, Polacin M, Priester M, Seifert V, Kogel D, Weissenberger J. The nontoxic natural compound Curcumin exerts anti-proliferative, anti-migratory, and anti-invasive properties against malignant gliomas. BMC Cancer. 2010 Sep 14;10:491. doi: 10.1186/1471-2407-10-491.