CancerGenePNSNCT03963700
Tumor Characteristics in Patients With Paraneoplastic Neurological Syndromes (PNS)
An observational study of Cancer and Paraneoplastic Syndromes, run by Hospices Civils de Lyon at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Cancer, Paraneoplastic Syndromes, Neurologic Disorder
- How many people
- 980 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2019to 1 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Absence of complete clinicopathological data
Trial locations and contacts
1 site in 1 country.
France1 site
Centre de référence des syndromes neurologiques paranéoplasiques et encéphalites auto-immunes
Lyon
About this study
Official title: 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.
Read more
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
- Medical subject headings
- Neoplasms, Paraneoplastic Syndromes, Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of mutations in cancer genes coding for onconeural proteins and inflammatory response mediators.
Genetic alterations in tumors associated with Paraneoplastic neurological syndromes (PNS)
Measured: 36 months
Secondary outcomes (1)
Proportion of different immune cells in the tumor's immune infiltrate
Histological immune infiltrate characteristics
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2019
- Study start1 Feb 2019
- Primary completion1 Jan 2022 (estimated)
- Study completion1 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 980 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jerome HONNORAT, PhD, Principal investigator, Centre de référence des syndromes neurologiques paranéoplasiques et encéphalites auto-immunes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03963700
- Sponsor's protocol ID
- GenePNS
- Acronym
- GenePNS
- Status last verified
- May 2019
- First submitted
- 26 Apr 2019
- Last updated
- 30 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genomic Profile and Tumor Immune Attack in Paraneoplastic Neurological Syndromes (PNS)
- ClinicalTrials.gov ID
- NCT03963700
- Acronym / sponsor ID
- GenePNS / GenePNS
- Conditions
- Cancer, Paraneoplastic Syndromes, Neurologic Disorder, Immune System and Related Disorders, Tumor Genetics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 980 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 1 Jan 2022 (estimated)
- Study completion
- 1 Jan 2022 (estimated)
- First posted
- 28 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Absence of complete clinicopathological data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
1 secondary outcome
Proportion of different immune cells in the tumor's immune infiltrate
Time frame: 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jerome HONNORAT, PhD principal investigator
Centre de référence des syndromes neurologiques paranéoplasiques et encéphalites auto-immunes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Paraneoplastic Syndromes, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of mutations in cancer genes coding for onconeural proteins and inflammatory response mediators. (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2019.