Tumor Characteristics in Patients With Paraneoplastic Neurological Syndromes (PNS)

NCT03963700 | Unknown

• 1 other identifier: GenePNS
• Study Type: observational
• Target: 980
• Locations: 1 country
• Sites: 1

Brief Summary

Paraneoplastic neurological syndromes (PNS) are immune-mediated complications of cancer that can affect any part of the central or peripheral nervous system. PNS occurs at the intersection between immune system and the tumor, where a combination of genetical and environmental factors may play a role. Mechanisms leading to immune tolerance breakdown and autoimmunity in PNS remain largely unknown, and this reflects in an unsatisfactory repertoire of treatments available. Moreover, a better understanding of the biological mechanisms underlying PNS would allow a more precise identification of the modalities that permit PNS patients to have a better oncological prognosis than cancer patient without PNS, with obvious repercussions in clinical oncology. To this effect, an extremely innovative approach involves directly exploring the tumoral tissue of patients suffering from specific PNS via genomic and transcriptomic analysis. The study team hypothesizes that antigen ectopic expression by tumour cells may contribute to the generation of PNS. In the present study, the investigators will analyze the salient features of tumors associated with PNS, namely the histological and immune cells infiltrate characteristics, their transcriptomic profile, and mutational status of involved antigens.

Conditions

Cancer; Paraneoplastic Syndromes; Neurologic Disorder; Immune System and Related Disorders; Tumor Genetics

Outcome Measures

Primary Outcomes (1)

• Proportion of mutations in cancer genes coding for onconeural proteins and inflammatory response mediators.

  Genetic alterations in tumors associated with Paraneoplastic neurological syndromes (PNS)

  36 months

Secondary Outcomes (1)

• Proportion of different immune cells in the tumor's immune infiltrate

  36 months

Study Arms (1)

Cancer patients with Paraneoplastic neurological syndromes

Cancer patients with Paraneoplastic neurological syndromes presenting various autoimmune anomalies: * Anti-Hu also known as anti-Neuron specific cell Nuclear Antibodies (anti-ANNA1) (350 patients), uncommon form of brain inflammation associated with an underlying cancer * anti-Yo (130 patients), antibody associated with paraneoplastic cerebellar degeneration * anti-Ma2 (50 patients), antibody associated with paraneoplastic encephalitis * anti-N-methyl-d-aspartate (NMDA) Receptor (350 patients), autoimmune disorder in which antibodies attack N-methyl-D-aspartate-type glutamate receptors * anti-gamma-aminobutyric acid-B (GABAb) receptor (35 patients), autoimmune disorder in which antibodies attack gamma-aminobutyric acid-B receptors * anti-alpha-amino-3-hydroxy-5-methylisoxazole-4-propionic acid (AMPA) receptor (15 patients), autoimmune disorder in which antibodies attack alpha-amino-3-hydroxy-5-methylisoxazole-4-propionic acid receptors * without antibodies (50 patients).

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with cancer and suspected Paraneoplastic neurological syndrome (PNS) whose sample was sent for analysis at the Centre de référence des syndromes neurologiques paranéoplasiques et encéphalites auto-immunes, Lyon, France, for paraneoplastic antibody study and then stored at the biobank Neurobiotec.

You may qualify if:

• presence of well characterized antibodies in serum or cerebrospinal fluid;
• histologically proven cancer with available tumour sample;
• Paraneoplastic neurological syndrome (PNS) diagnosis according to the international guidelines;
• Age: at least 18 years old.

You may not qualify if:

• Absence of complete clinicopathological data

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Centre de référence des syndromes neurologiques paranéoplasiques et encéphalites auto-immunes

Lyon, France

Location

MeSH Terms

Conditions

Neoplasms; Paraneoplastic Syndromes; Nervous System Diseases

Study Officials

• Jerome HONNORAT, PhD

  Centre de référence des syndromes neurologiques paranéoplasiques et encéphalites auto-immunes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2019
• First Posted: May 28, 2019
• Study Start: February 1, 2019
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2022
• Last Updated: May 30, 2019

Record last verified: 2019-05

Locations

FR (1)