GliomaGLIONOTCHNCT04809597
Does Notch Regulate Glioma Proliferation ?
An observational study of Glioma, run by University Hospital, Montpellier at 1 site in France.
Trial summary
The investigators showed in 2015 (Guichet et al) that the Notch1 pathway has an anti-proliferative role on glial brain tumors. In this project, the investigators investigated which genes downstream of Notch1 pathway activation produce the anti-proliferative effect. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioma
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2012to 20 Jan 2021
- 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: Cases with brain diffuse low grade and high grade gliomas (glioblastomas)
Who may be able to join
- Patient ≥18 years old
- Patient affected with brain glioma classified according to WHO 2016 classification
Who cannot join
- Patient who reject the study protocol
- Radiotheray or chemotherapy treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Activity and Role of Notch1 Signalling in Glioma
The investigators showed in 2015 (Guichet et al) that the Notch1 pathway has an anti-proliferative role on glial brain tumors. In this project, the investigators investigated which genes downstream of Notch1 pathway activation produce the anti-proliferative effect. The investigators hypothesized that the SNAI2 and TAL1 genes act downstream of Notch1
Read the detailed description
Main objectives:
To examine the expression of TAL1 and SNAI2 in protein extracts and glioma sections of different grades (glioblastomas and diffuse low-grade tumors).
To examine the effect of overexpression of Tal1 and Snai2 in high grade glioma cultures.
To show the expression of Tal1 and SNAI2 by tumor cells by FISH technique. Show that TAL1 and SNAI2 could be regulated by endothelial cells
- Conditions
- Glioma
- Keywords
- pathologist-graded gliomas
- Medical subject headings
- Glioma
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of Notch1 activation on Tal1
highthroughput gene analysis (DNA arrays) with cells transduced with activated form of Notch1
Measured: 1 day
Snai2 gene and protein expression
western blot for Tal1 and Snai2 in protein extracted from low grade and high gliomas
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2021
- Study start1 Jan 2012
- Primary completion1 Jan 2021
- Study completion20 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GliomaStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Philippe Hugnot, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04809597
- Sponsor's protocol ID
- RECHMPL21_0172
- Acronym
- GLIONOTCH
- Status last verified
- Mar 2021
- First submitted
- 17 Mar 2021
- Last updated
- 22 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Activity and Role of Notch1 Signalling in Glioma
- ClinicalTrials.gov ID
- NCT04809597
- Acronym / sponsor ID
- GLIONOTCH / RECHMPL21_0172
- Conditions
- Glioma
- Keywords
- pathologist-graded gliomas
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 20 Jan 2021 (actual)
- First posted
- 22 Mar 2021 (actual)
- 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 investigators showed in 2015 (Guichet et al) that the Notch1 pathway has an anti-proliferative role on glial brain tumors. In this project, the investigators investigated which genes downstream of Notch1 pathway activation produce the anti-proliferative effect. The investigators hypothesized that the SNAI2 and TAL1 genes act downstream of Notch1
Detailed description
Main objectives:
To examine the expression of TAL1 and SNAI2 in protein extracts and glioma sections of different grades (glioblastomas and diffuse low-grade tumors).
To examine the effect of overexpression of Tal1 and Snai2 in high grade glioma cultures.
To show the expression of Tal1 and SNAI2 by tumor cells by FISH technique. Show that TAL1 and SNAI2 could be regulated by endothelial cells
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cases with brain diffuse low grade and high grade gliomas (glioblastomas)
Key inclusion criteria (2 listed)
- Patient ≥18 years old
- Patient affected with brain glioma classified according to WHO 2016 classification
Key exclusion criteria (2 listed)
- Patient who reject the study protocol
- Radiotheray or chemotherapy treatment
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
Effect of Notch1 activation on Tal1
Time frame: 1 day
highthroughput gene analysis (DNA arrays) with cells transduced with activated form of Notch1
Snai2 gene and protein expression
Time frame: 1 day
western blot for Tal1 and Snai2 in protein extracted from low grade and high gliomas
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 22 Mar 2021.
- Individual participant dataSharing planned: Undecided. NC
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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. This study is not recruiting at the moment.
Jean-Philippe Hugnot study director
University Hospital, Montpellier
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 Hospital, Montpellier at 1 site in France.
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 22 Mar 2021. 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 France. 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?
Effect of Notch1 activation on Tal1 (time frame: 1 day). 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?
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 22 Mar 2021.