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Official title Autoimmune Neurological Diseases and Those Secondary to Immunotherapy: Study of Immunological Mechanisms and Research Into Targets of Immune Attack
ClinicalTrials.gov ID: NCT07456358
What this study is testing
- What it's testing
- The pathophysiology of neurological toxicities secondary to immune checkpoint inhibitors (ICIs) is unknown. Various mechanisms have been proposed: activation of cytotoxic CD8 T cells, autoantibodies via activation of B cells and CD4 cells, non-specific inflammation through the production of pro-inflammatory cytokines, and complement activation.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- Adult patient (aged ≥ 18 years)
- Affiliated with a social security scheme
- Express consent to participate in the study
- Indication for lumbar puncture And
- Patients with cancer, undergoing treatment with ICIs, presenting neurological symptoms after starting treatment with ICIs. These symptoms must have...
You likely can't join if
- Contraindication or refusal to perform a lumbar puncture
- Sample not suitable for research (volume of CSF collected for treatment \>5 mL)
- Corticosteroid therapy or other immunomodulatory treatment in progress (discontinued less than 15 days prior to inclusion)
- Pregnant or breastfeeding women
- Not affiliated with the social security system, patients under French State Medical Aid for undocumented migrants
- Patients under guardianship or curatorship, under judicial protection measures, or deprived of their liberty by judicial or administrative decision
See the full eligibility criteria
- Adult patient (aged ≥ 18 years)
- Affiliated with a social security scheme
- Express consent to participate in the study
- Indication for lumbar puncture And
- Patients with cancer, undergoing treatment with ICIs, presenting neurological symptoms after starting treatment with ICIs. These symptoms must have appeared no more than 3 months after the last administration of ICIs. Or
- Patients with an autoimmune disease of the central nervous system (diagnosis made by teams 1, 2 and 3) according to internationally recognised criteria, with no history of active cancer in the last 3 years and no other...
- Patients with normal pressure hydrocephalus (NPH) or idiopathic intracranial hypertension (diagnosed based on imaging (brain MRI) and clinical findings), with no history of active cancer in the last 3 years and no...
- Contraindication or refusal to perform a lumbar puncture
- Sample not suitable for research (volume of CSF collected for treatment \>5 mL)
- Corticosteroid therapy or other immunomodulatory treatment in progress (discontinued less than 15 days prior to inclusion)
- Pregnant or breastfeeding women
- Not affiliated with the social security system, patients under French State Medical Aid for undocumented migrants
- Patients under guardianship or curatorship, under judicial protection measures, or deprived of their liberty by judicial or administrative decision
The study team makes the final eligibility decision.
Where it's taking place
- Le Kremlin-Bicêtre, France
- Paris, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Le Kremlin-Bicêtre, France; Paris, France. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.