NCT07398170

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

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
13mo left

Started Mar 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress17%
Mar 2026Jul 2027

First Submitted

Initial submission to the registry

February 2, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 9, 2026

Completed
20 days until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

February 9, 2026

Status Verified

January 1, 2026

Enrollment Period

1.3 years

First QC Date

February 2, 2026

Last Update Submit

February 2, 2026

Conditions

Keywords

Meningioma diagnosisCirculating tumor cellsLiquid BiopsyNeoplasm Recurrence, LocalTherapyBiomarkers

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

EXPERIMENTAL
Other: Blood samplingOther: Lumbar puncture

Interventions

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.

Experimental arm

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.

Experimental arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Conditions

MeningiomaNeoplastic Cells, CirculatingNeoplasm Recurrence, Local

Interventions

Blood Specimen CollectionSpinal Puncture

Condition Hierarchy (Ancestors)

Neoplasms, Nerve TissueNeoplasms by Histologic TypeNeoplasmsNeoplasms, Vascular TissueMeningeal NeoplasmsCentral Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNervous System DiseasesNeoplasm MetastasisNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative TechniquesBiopsyDiagnostic Techniques, NeurologicalTherapeutics

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

Locations