Tumor Characteristics in Patients With Paraneoplastic Neurological Syndromes (PNS)

Cancer Clinical Trial

— GenePNS  

Official title:

Genomic Profile and Tumor Immune Attack in Paraneoplastic Neurological Syndromes (PNS)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03963700
• Other study ID #: GenePNS
• Status: Active, not recruiting
• Start date: February 1, 2019
• Est. completion date: January 1, 2022

Study information

• Verified date: May 2019
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 980
• Est. completion date: January 1, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Absence of complete clinicopathological data

Related Conditions & MeSH terms

• Cancer
• Disease
• Immune System and Related Disorders
• Nervous System Diseases
• Neurologic Disorder
• Paraneoplastic Syndromes
• Syndrome
• Tumor Genetics

Locations

Country	Name	City	State
France	Centre de référence des syndromes neurologiques paranéoplasiques et encéphalites auto-immunes	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Proportion of different immune cells in the tumor's immune infiltrate	Histological immune infiltrate characteristics	36 months