Clinico-immunological Characterization and Immune Tolerance Breakdown in CV2-autoimmunity (CarTo-CV2)

September 30, 2024 updated by: Hospices Civils de Lyon
Paraneoplastic neurological syndromes are rare syndromes caused by the remote effects of cancer. They have an immune-mediated pathogenesis, yet the underlying mechanisms are not fully elucidated. CV2/Collapsin response-mediator protein 5 (CRMP5)-IgG paraneoplastic neurological syndrome is characterized by heterogeneous clinical presentations, affecting both central and peripheral nervous system, and the most frequently associate tumor is small cell lung carcinoma. Central nervous system involvement along with CSF and neuroimaging findings have not been fully described in the literature in CV2/CRMP5 patients. Unraveling the complexities of CV2/CRMP5 paraneoplastic neurological syndrome is critical to improve diagnosis, treatment, and patients' care. Our intention is to perform a comprehensive analysis of the clinical characteristics and instrumental investigations of a large cohort of CV2/CRMP5 patients.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

232

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bron, France, 69677
        • Hôpital Neurologique Pierre Wertheimer / Groupement Hospitalier Est

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients harboring CV2 Abs in serum and/or CSF with or without cancer.

Description

Inclusion Criteria:

  • Patient with paraneoplastic neurological syndromes
  • Patient with CV2 antibody in sera and/or CSF

Exclusion Criteria:

  • Patient with no data
  • Patient without neurological disorder
  • Patient without CV2 antibody in sera/CSF

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with CV2 Abs
Patients harboring CV2 Abs and a paraneoplastic neurological syndromes.
Other: Description of clinical, immunological and tumor features of patients harboring CV2 Abs
This is a non-interventional study involving clinical data and biological samples (DNA and tumors block). Demographic and clinical data already collected in the database of the French Reference Center on PNS will be reviewed. The diagnostic tests performed to detect CV2-Abs in the patients already included in the database of the French Reference Center on PNS will be retrospectively analyzed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modified Rankin Scale (mRs)
Time Frame: At baseline, 3, 6, 12, 18 month
Application of modified rankin scale
At baseline, 3, 6, 12, 18 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: Pr Jérôme Honnorat, Pr, Centre de référence des syndromes neurologiques paranéoplasiques et encéphalites auto-immunes, Lyon, France.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2024

Primary Completion (Actual)

September 1, 2024

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

September 27, 2024

First Submitted That Met QC Criteria

September 30, 2024

First Posted (Actual)

October 1, 2024

Study Record Updates

Last Update Posted (Actual)

October 1, 2024

Last Update Submitted That Met QC Criteria

September 30, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24-5225

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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