Search for Circulating Tumour Cells in the Blood and/or Cerebrospinal Fluid in Patients With Recurrent Aggressive Meningiomas: Proof-of-concept Study
BIOLIMEN-1
1 other identifier
interventional
15
1 country
1
Brief Summary
The goal of the clinical trial is to assess the presence of circulating tumor cells (CTCs) in the blood and/or cerebrospinal fluid (CSF) of patients with aggressive recurrent meningiomas.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 2, 2026
CompletedFirst Posted
Study publicly available on registry
February 9, 2026
CompletedStudy Start
First participant enrolled
March 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2027
February 9, 2026
January 1, 2026
1.3 years
February 2, 2026
February 2, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Detection rate of circulating tumour cells (CTC) in blood
i.e the proportion of patients with at least one CTC in the venous blood sample
Before treatment of meningioma recurrence and at the end of meningioma recurrence treatment on Day 90 (± 15 days) in case of radiotherapy, or on Day 1 post-surgery in case of surgery
Detection rate of circulating tumour cells (CTC) in cerebrospinal fluid
i.e the proportion of patients with at least one CTC in the cerebrospinal fluid
Before treatment of meningioma recurrence
Secondary Outcomes (4)
Presence of circulating tumour cells (CTC) in blood
Before treatment of meningioma recurrence and at the end of meningioma recurrence treatment on Day 90 (± 15 days) in case of radiotherapy, or on Day 1 post-surgery in case of surgery
Presence of circulating tumour cells (CTC) in cerebrospinal fluid
Before treatment of meningioma recurrence
Number of circulating tumour cells (CTC) in blood
Before treatment of meningioma recurrence and at the end of meningioma recurrence treatment on Day 90 (± 15 days) in case of radiotherapy, or on Day 1 post-surgery in case of surgery
Number of circulating tumour cells (CTC) in cerebrospinal fluid
Before treatment of meningioma recurrence
Study Arms (1)
Experimental arm
EXPERIMENTALInterventions
At the diagnosis of meningioma recurrence: a blood sample of 28 mL of whole blood (i.e., 4 EDTA tubes of 7 mL each) and at the end of meningioma recurrence treatment: a blood sample of 28 mL of whole blood (i.e., 4 EDTA tubes of 7 mL each) will be collect.
At the time of diagnosis of meningioma recurrence :a cerebrospinal fluid (CSF) sample obtained by lumbar puncture, in the absence of contraindications verified by the investigator, collected in one dry tube of 4 mL.
Eligibility Criteria
You may qualify if:
- Over 18 years of age
- Operated on for a grade 2 or 3 meningioma at Montpellier University Hospital between 2015 and 2024
- Tumour expressing SSTR2A on the initial surgical specimen
- Clinical and/or radiological recurrence as determined by MRI imaging (progression of a residual lesion OR appearance of a new lesion consistent with a meningioma at the surgical site or elsewhere)
You may not qualify if:
- Other active ongoing cancer
- Contraindications to lumbar puncture:
- Intracranial hypertension with meningioma exerting a mass effect and obstruction of the cerebrospinal fluid (CSF) pathway/risk of trans-tentorial or amygdalar herniation
- Blood clotting disorder with risk of haematoma at the puncture site (anticoagulant treatment at therapeutic dose or antiplatelet therapy, thrombocytopenia or thrombopathy)
- Infection at the puncture site
- Pregnant or breastfeeding women (Article L.1121-5 of the French Public Health Code)
- Persons deprived of their liberty by judicial or administrative decision (Article L.1121-6 of the French Public Health Code)
- Persons who are subject to legal protection measures or who are unable to express their consent (guardianship, curatorship, judicial protection; Article L.1121-8 of the French Public Health Code)
- Not affiliated with a social security scheme or beneficiary of such a scheme (Article L.1121-8-1 of the French Public Health Code)
- Failure to obtain written informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU de Montpellier
Montpellier, France, 34295, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 2, 2026
First Posted
February 9, 2026
Study Start
March 1, 2026
Primary Completion (Estimated)
July 1, 2027
Study Completion (Estimated)
July 1, 2027
Last Updated
February 9, 2026
Record last verified: 2026-01