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Search for Circulating Tumour Cells in the Blood and/or Cerebrospinal Fluid in Patients With Recurrent Aggressive Meningiomas: Proof-of-concept Study

ConditionMeningioma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Montpellier

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

Other active ongoing cancer

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Blood sampling

    Other intervention

    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.

  • Lumbar puncture

    Other intervention

    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.

Treatment groups

15 Participants
are divided into 1 treatment group
Group A: Experimental armExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
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
2

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

Time frame
Before treatment of meningioma recurrence

Secondary outcomes

1

Presence of circulating tumour cells (CTC) in blood

i.e defined as the presence of at least one CTC in the blood sample

Time frame
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
2

Presence of circulating tumour cells (CTC) in cerebrospinal fluid

i.e defined as the presence of at least one CTC in the cerebrospinal fluid sample

Time frame
Before treatment of meningioma recurrence
3

Number of circulating tumour cells (CTC) in blood

Time frame
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
4

Number of circulating tumour cells (CTC) in cerebrospinal fluid

Time frame
Before treatment of meningioma recurrence

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Montpellier

Lead sponsor

Source ClinicalTrials.gov
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