GliomaLoG-GlioNCT02686229
Registry Study on Epidemiological and Biological Disease Profile as Well as Clinical Outcome in Patients With Low Grade Gliomas
An observational study of Glioma, run by University of Ulm at 1 site in Germany.
Trial summary
The LoG-Glio-Registry is based on a network of german hospitals gathering radiological, clinical, epidemiological and molecular data on all patients diagnosed with a low grade glioma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioma
- How many people
- 300 participants
- Where
- 1 siteGermany
- Study dates
- 15 Nov 2015to Dec 2036
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: All adult patients with radiological suspected diagnosis of a low grade glioma
Who may be able to join
- Patients with radiological suspected diagnosis of a low grade glioma
- Age ≥ 18 years. There is no upper age limit.
Who cannot join
- Severe neurological or psychiatric disorder interfering with ability to give an informed consent
- No consent for registration, storage and processing of the individual disease characteristics and course as well as information of the family physician about study participation
- No consent for bio-banking of patient's biological specimens and performance of analyses on stored material.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
University of Ulm
Ulm
Jan Coburger, MD, jan.coburger@uni-ulm.de
About this study
Official title: Registry Study on Epidemiological and Biological Disease Profile as Well as Clinical Outcome in Patients With Low Grade Gliomas: The LOG-Glio-Project
The LoG-Glio-Registry is based on a network of german hospitals gathering radiological, clinical, epidemiological and molecular data on all patients diagnosed with a low grade glioma.
- Conditions
- Glioma
- Being tested
- no interventions
- Keywords
- Low grade glioma, registry, neurosurgery, brain tumor
- Medical subject headings
- Glioma, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionsOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
Measured: 5yrs
Overall survival (OS)
Measured: 15yrs
Secondary outcomes (2)
Extent of tumor resection
calculated based on volumetric assessement of tumor in cm³ and residual tumor in pre and postoperative MRI
Measured: 3yrs
Quality of life (QoL) assessed by the EORTC QLQ C-30/BN-20. (European Organisation for Research and Treatment of Cancer Quality of Life Questionaire C-30
Measured: 5yrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2016 (estimated)
- Study start15 Nov 2015
- Primary completion31 Dec 2026 (estimated)
- Study completionDec 2036 (estimated)
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 GliomaStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- University of Ulm
- Sponsor type
- University, hospital or other
- Collaborators
- Charite University, Berlin, Germany
- Responsible party
- Principal investigator, Jan Coburger, University of Ulm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02686229
- Sponsor's protocol ID
- LoG-Glio
- Acronym
- LoG-Glio
- Status last verified
- May 2023
- First submitted
- 4 Feb 2016
- Last updated
- 11 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Pala A, Nadji-Ohl M, Faust K, Ruckriegel S, Roder C, von der Brelie C, Forster MT, Lobel F, Schommer S, Lohr M, Renovanz M, Grubel N, Rothenbacher D, Konig R, Engelke J, Schmitz B, Wirtz CR, Ringel F, Senft C, Rohde V, Tatagiba M, Ernestus RI, Vajkoczy P, Ganslandt O, Nagel G, Coburger J. Multicentric Registry Study on Epidemiological and Biological Disease Profile as Well as Clinical Outcome in Patients with Low-Grade Gliomas: The LoG-Glio Project. J Neurol Surg A Cent Eur Neurosurg. 2020 Jan;81(1):48-57. doi: 10.1055/s-0039-1693650. Epub 2019 Sep 24.
PubMed 31550737
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry Study on Epidemiological and Biological Disease Profile as Well as Clinical Outcome in Patients With Low Grade Gliomas: The LOG-Glio-Project
- ClinicalTrials.gov ID
- NCT02686229
- Acronym / sponsor ID
- LoG-Glio / LoG-Glio
- Conditions
- Glioma
- Keywords
- Low grade glioma, registry, neurosurgery, brain tumor
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of UlmUniversity, hospital or other
- Collaborators
- Charite University, Berlin, Germany
- Study start
- 15 Nov 2015 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- Dec 2036 (estimated)
- First posted
- 19 Feb 2016 (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.
The LoG-Glio-Registry is based on a network of german hospitals gathering radiological, clinical, epidemiological and molecular data on all patients diagnosed with a low grade glioma.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients with radiological suspected diagnosis of a low grade glioma
Key inclusion criteria (2 listed)
- Patients with radiological suspected diagnosis of a low grade glioma
- Age ≥ 18 years. There is no upper age limit.
Key exclusion criteria (3 listed)
- Severe neurological or psychiatric disorder interfering with ability to give an informed consent
- No consent for registration, storage and processing of the individual disease characteristics and course as well as information of the family physician about study participation
- No consent for bio-banking of patient's biological specimens and performance of analyses on stored material.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventions | Other | – |
Primary outcome
Progression-free survival (PFS)
Time frame: 5yrs
Overall survival (OS)
Time frame: 15yrs
2 secondary outcomes
Extent of tumor resection
Time frame: 3yrs
Quality of life (QoL) assessed by the EORTC QLQ C-30/BN-20. (European Organisation for Research and Treatment of Cancer Quality of Life Questionaire C-30
Time frame: 5yrs
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2023.
- Derived from this study: PubMed 31550737Pala A, Nadji-Ohl M, Faust K, Ruckriegel S, Roder C, von der Brelie C, Forster MT, Lobel F, Schommer S, Lohr M, Renovanz M, Grubel N, Rothenbacher D, Konig R, Engelke J, Schmitz B, Wirtz CR, Ringel F, Senft C, Rohde V, Tatagiba M, Ernestus RI, Vajkoczy P, Ganslandt O, Nagel G, Coburger J. Multicentric Registry Study on Epidemiological and Biological Disease Profile as Well as Clinical Outcome in Patients with Low-Grade Gliomas: The LoG-Glio Project. J Neurol Surg A Cent Eur Neurosurg. 2020 Jan;81(1):48-57. doi: 10.1055/s-0039-1693650. Epub 2019 Sep 24.
- Individual participant dataSharing planned: No
Related trials for Glioma
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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.
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 Glioma, run by University of Ulm 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 3 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: looking for participants now, as of the sponsor's last update on 11 May 2023. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jan Coburge, MD (082219628858, jan.coburger@uni-ulm.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) (time frame: 5yrs). The study lists 2 primary outcomes in all. 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 NCT02686229, 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 11 May 2023.