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Tumor Characteristics in Patients With Paraneoplastic Neurological Syndromes (PNS) (GenePNS)
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.
| Condition or disease |
|---|
| Cancer Paraneoplastic Syndromes Neurologic Disorder Immune System and Related Disorders Tumor Genetics |
| Study Type : | Observational |
| Estimated Enrollment : | 980 participants |
| Observational Model: | Case-Control |
| Time Perspective: | Retrospective |
| Official Title: | Genomic Profile and Tumor Immune Attack in Paraneoplastic Neurological Syndromes (PNS) |
| Actual Study Start Date : | February 1, 2019 |
| Estimated Primary Completion Date : | January 1, 2022 |
| Estimated Study Completion Date : | January 1, 2022 |
| Group/Cohort |
|---|
|
Cancer patients with Paraneoplastic neurological syndromes
Cancer patients with Paraneoplastic neurological syndromes presenting various autoimmune anomalies:
|
- 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)
- Proportion of different immune cells in the tumor's immune infiltrate [ Time Frame: 36 months ]Histological immune infiltrate characteristics
| Ages Eligible for Study: | 18 Years to 100 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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
| France | |
| Centre de référence des syndromes neurologiques paranéoplasiques et encéphalites auto-immunes | |
| Lyon, France | |
| Principal Investigator: | Jerome HONNORAT, PhD | Centre de référence des syndromes neurologiques paranéoplasiques et encéphalites auto-immunes |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | April 26, 2019 | ||||
| First Posted Date | May 28, 2019 | ||||
| Last Update Posted Date | May 30, 2019 | ||||
| Actual Study Start Date | February 1, 2019 | ||||
| Estimated Primary Completion Date | January 1, 2022 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
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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| Original Primary Outcome Measures |
Genetic alterations in tumors associated with Paraneoplastic neurological syndromes (PNS) [ Time Frame: 36 months ] The proportion of mutations in cancer genes coding for onconeural proteins and inflammatory response mediators.
|
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| Change History | |||||
| Current Secondary Outcome Measures |
Proportion of different immune cells in the tumor's immune infiltrate [ Time Frame: 36 months ] Histological immune infiltrate characteristics
|
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| Original Secondary Outcome Measures |
Histological immune infiltrate characteristics [ Time Frame: 36 months ] The proportion of different immune cells in the tumor's immune infiltrate
|
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| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Tumor Characteristics in Patients With Paraneoplastic Neurological Syndromes (PNS) | ||||
| Official Title | Genomic Profile and Tumor Immune Attack in Paraneoplastic Neurological Syndromes (PNS) | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type | Observational | ||||
| Study Design | Observational Model: Case-Control Time Perspective: Retrospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| 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. | ||||
| Condition |
|
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| Intervention | Not Provided | ||||
| Study Groups/Cohorts | Cancer patients with Paraneoplastic neurological syndromes
Cancer patients with Paraneoplastic neurological syndromes presenting various autoimmune anomalies:
|
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Active, not recruiting | ||||
| Estimated Enrollment |
980 | ||||
| Original Estimated Enrollment | Same as current | ||||
| Estimated Study Completion Date | January 1, 2022 | ||||
| Estimated Primary Completion Date | January 1, 2022 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years to 100 Years (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | France | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03963700 | ||||
| Other Study ID Numbers | GenePNS | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement | Not Provided | ||||
| Responsible Party | Hospices Civils de Lyon | ||||
| Study Sponsor | Hospices Civils de Lyon | ||||
| Collaborators | Not Provided | ||||
| Investigators |
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| PRS Account | Hospices Civils de Lyon | ||||
| Verification Date | May 2019 | ||||
