Patient Harboring Glioblastoma That Will Undergo SurgeryNCT01712542
Curcumin Bioavailability in Glioblastoma Patients
An observational study of Patient Harboring Glioblastoma That Will Undergo Surgery, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
Trial summary
Measuring the bioavailability of orally administered curcumin in the tumors of glioblastoma patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patient Harboring Glioblastoma That Will Undergo Surgery
- How many people
- 15 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2012to May 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients harboring Glioblastoma
Who may be able to join
- Patients harboring Glioblastoma
- Patient will undergo surgery
Who cannot join
- BMI > 30
- Liver and Kidney Function so compromised that medication is prescribed
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Neurosurgery, Johann Wolfgang Goethe-University
Frankfurt am Main, Hesse, 60528
About this study
Official title: Measurement of Intratumoral Concentration of the Nontoxic Natural Compound Curcumin in Glioblastoma Patients
Measuring the bioavailability of orally administered curcumin in the tumors of glioblastoma patients.
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of Curcumin in Glioblastoma
At the time of surgery
Measured: At Tumor resection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patient Harboring Glioblastoma That Will Undergo SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johann Wolfgang Goethe University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephan Dützmann, Johann Wolfgang Goethe University Hospital
- Investigators
- Stephan Duetzmann, Principal investigator, Goethe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01712542
- Sponsor's protocol ID
- JohannWGUH_Curcumin-01
- Status last verified
- Jun 2013
- First submitted
- 20 Oct 2012
- Last updated
- 4 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 20840775
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Intratumoral Concentration of the Nontoxic Natural Compound Curcumin in Glioblastoma Patients
- ClinicalTrials.gov ID
- NCT01712542
- Acronym / sponsor ID
- JohannWGUH_Curcumin-01
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Johann Wolfgang Goethe University HospitalUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 23 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Measuring the bioavailability of orally administered curcumin in the tumors of glioblastoma patients.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients harboring Glioblastoma
Key inclusion criteria (2 listed)
- Patients harboring Glioblastoma
- Patient will undergo surgery
Key exclusion criteria (2 listed)
- BMI > 30
- Liver and Kidney Function so compromised that medication is prescribed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Concentration of Curcumin in Glioblastoma
Time frame: At Tumor resection
At the time of surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2013.
- Background: PubMed 20840775Senft 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephan Duetzmann principal investigator
Goethe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patient Harboring Glioblastoma That Will Undergo Surgery, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of Curcumin in Glioblastoma (time frame: At Tumor resection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01712542, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2013.