- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03963700
Tumor Characteristics in Patients With Paraneoplastic Neurological Syndromes (PNS) (GenePNS)
Genomic Profile and Tumor Immune Attack in Paraneoplastic Neurological Syndromes (PNS)
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.
Study Overview
Status
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
-
Lyon, France
- Centre de référence des syndromes neurologiques paranéoplasiques et encéphalites auto-immunes
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Cancer patients with Paraneoplastic neurological syndromes
Cancer patients with Paraneoplastic neurological syndromes presenting various autoimmune anomalies:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of mutations in cancer genes coding for onconeural proteins and inflammatory response mediators.
Time Frame: 36 months
|
Genetic alterations in tumors associated with Paraneoplastic neurological syndromes (PNS)
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36 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of different immune cells in the tumor's immune infiltrate
Time Frame: 36 months
|
Histological immune infiltrate characteristics
|
36 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GenePNS
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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