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Active, Not Recruiting

NCT Number: NCT06620913

Clinico-immunological Characterization and Immune Tolerance Breakdown in CV2-autoimmunity

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

CV2 Autoimmunity Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Neurologique Pierre Wertheimer / Groupement Hospitalier Est

Bron, 69677, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Description of clinical, immunological and tumor features of patients harboring CV2 Abs

Other

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.

Primary outcomes

  1. Modified Rankin Scale (mRs)

    Time frame: At baseline, 3, 6, 12, 18 month

    Application of modified rankin scale

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: CarTo-CV2

Important dates

Study start
2024
Primary completion
2024
Study completion
2026
First posted
Oct 1, 2024
Registry last updated
Oct 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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