GlioblastomaMUCIGLIO-01NCT06001281
Predictive Value of Soluble CD146 in Glioblastoma Patients
A study testing plasma collection in people with Glioblastoma, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
Glioblastoma is the most common malignant primary brain tumor with poor prognosis because of its diffusive and infiltrative nature. The FDA approved the use of the anti-VEGF antibody bevacizumab in recurrent GBM. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma
- What is being tested?
- plasma collection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteFrance
- Study dates
- 30 Jan 2024to Dec 2026
- Phase
- Interventional
- 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
Who may be able to join
- - Adult patients with recurrent IDHwt glioblastoma
- Relapse after standard first line treatment (radio-chemotherapy)
- Candidate for bevacizumab treatment
- Able to be monitored by MRI
- KPS ≥ 60%
- Written signed consent form
Who cannot join
- Pregnancy or breast feeding
- Life expectancy less than 3 months
- Bevacizumab in first line treatment
- Other concomitant life-threatening disease
- Under legal protection
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
DRSMR AP-HM contact
France1 site, 1 recruiting
- Recruiting
Service de Neuro-oncologie
Marseille, 13005
TABOURET Emeline, 0491385500 ext. 33, emeline.tabouret@ap-hm.fr
About this study
Official title: Predictive Value of Soluble CD146 in Patients With Recurrent Glioblastoma Treated by Bevacizumab
Glioblastoma is the most common malignant primary brain tumor with poor prognosis because of its diffusive and infiltrative nature. The FDA approved the use of the anti-VEGF antibody bevacizumab in recurrent GBM. However, resistance to this anti-angiogenic reagent is frequent and fails to enhance patients' overall survival. The investigators previously identified one novel mechanism responsible for bevacizumab-resistance in CD146-positive glioblastoma (Joshkon et al. Acta Neuropathol Commun, 2022).
Now, the investigators objective is to prospectively monitor the soluble CD146 value in plasma from patients treated by bevacizumab for recurrent glioblastoma.
Read more
The investigators will collect plasma at baseline, before the first bevacizumab administration, before the second administration, at the time of first MRI evaluation and at progression. Plasma CD146 value will be analyzed by ELISA.
The investigators expect to confirm the correlation between soluble CD146 value in plasma and patient response to bevacizumab.
- Conditions
- Glioblastoma
- Being tested
- plasma collection
- Keywords
- glioblastoma, CD146, bevacizumab
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
plasma collectionOther
Plasma samples will be prospectively collected at relevant time points during patient treatment.
| Study group | Role | What they receive |
|---|---|---|
| plasma collection | Other | Plasma samples will be prospectively collected at relevant time points during patient treatment. Receives: Other: plasma collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
correlation between soluble CD146 plasma value and patient response (RANO)
Soluble CD146 plasma value will be assessed using ELISA. Patient response will be evaluated by MRI and clinical response using the international RANO criteria.
Measured: first evaluation (2 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start30 Jan 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emeline Tabouret, Principal investigator, AP-HM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06001281
- Sponsor's protocol ID
- RCAPHM23_0011
- Other IDs
- ID RCB
- Acronym
- MUCIGLIO-01
- Status last verified
- Aug 2023
- First submitted
- 14 Aug 2023
- Last updated
- 2 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Value of Soluble CD146 in Patients With Recurrent Glioblastoma Treated by Bevacizumab
- ClinicalTrials.gov ID
- NCT06001281
- Acronym / sponsor ID
- MUCIGLIO-01 / RCAPHM23_0011
- Conditions
- Glioblastoma
- Keywords
- glioblastoma, CD146, bevacizumab
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 30 Jan 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 21 Aug 2023 (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.
Glioblastoma is the most common malignant primary brain tumor with poor prognosis because of its diffusive and infiltrative nature. The FDA approved the use of the anti-VEGF antibody bevacizumab in recurrent GBM. However, resistance to this anti-angiogenic reagent is frequent and fails to enhance patients' overall survival. The investigators previously identified one novel mechanism responsible for bevacizumab-resistance in CD146-positive glioblastoma (Joshkon et al. Acta Neuropathol Commun, 2022).
Now, the investigators objective is to prospectively monitor the soluble CD146 value in plasma from patients treated by bevacizumab for recurrent glioblastoma.
The investigators will collect plasma at baseline, before the first bevacizumab administration, before the second administration, at the time of first MRI evaluation and at progression. Plasma CD146 value will be analyzed by ELISA.
The investigators expect to confirm the correlation between soluble CD146 value in plasma and patient response to bevacizumab.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| plasma collection | Other | Other: plasma collectionPlasma samples will be prospectively collected at relevant time points during patient treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- - Adult patients with recurrent IDHwt glioblastoma
- Relapse after standard first line treatment (radio-chemotherapy)
- Candidate for bevacizumab treatment
- Able to be monitored by MRI
- KPS ≥ 60%
Key exclusion criteria (5 listed)
- Pregnancy or breast feeding
- Life expectancy less than 3 months
- Bevacizumab in first line treatment
- Other concomitant life-threatening disease
- Under legal protection
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 |
|---|---|---|
| plasma collectionPlasma samples will be prospectively collected at relevant time points during patient treatment. | Other | plasma collection |
Primary outcome
correlation between soluble CD146 plasma value and patient response (RANO)
Time frame: first evaluation (2 months)
Soluble CD146 plasma value will be assessed using ELISA. Patient response will be evaluated by MRI and clinical response using the international RANO criteria.
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 2 Feb 2024.
- Individual participant dataSharing planned: No
Related trials for Glioblastoma
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Testing the Addition of an Anti-cancer Drug, Selinexor, to the Usual Chemotherapy Treatment (Temozolomide) for Brain Tumors That Have Returned After Previous Treatment
Recurrent Glioblastoma, IDH-Wildtype, Recurrent MGMT-Methylated Glioblastoma
Active, not recruitingPhase 1
Oral Gallium Maltolate for the Treatment of Relapsed and Refractory Glioblastoma
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PLX038 in Primary Central Nervous System Tumors Containing MYC or MYCN Amplifications
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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.
DRSMR AP-HM contact
Emeline Tabouret principal investigator
AP-HM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing plasma collection in people with Glioblastoma, run by Assistance Publique Hopitaux De Marseille 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 6 inclusion and 5 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 2 Feb 2024. 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?
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 Emeline Tabouret (0491385500 ext. 33, emeline.tabouret@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
correlation between soluble CD146 plasma value and patient response (RANO) (time frame: first evaluation (2 months)). 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 2 Feb 2024.