The Study of Immune Cell (T Cell) Activity in Patients With Paraneoplastic Neurologic Syndromes
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Purpose
The investigators believe that T cells, cells that are a part of the immune system, are what are causing the neurological problems while also attacking tumor cells. This protocol studies the clinical status of patients with paraneoplastic neurological disorder (PND) as well as their blood to understand the relationship between their neurological disease, their cancer, and their immune system.
| Condition |
|---|
|
Paraneoplastic Syndromes |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Killer T Cell Activity in the Paraneoplastic Neurologic Syndromes |
serum, cells)
| Estimated Enrollment: | 100 |
| Study Start Date: | January 1995 |
| Estimated Study Completion Date: | December 2015 |
| Estimated Primary Completion Date: | December 2015 (Final data collection date for primary outcome measure) |
Patients with paraneoplastic neurological disorders (PNDs) provide a unique model for studying tumor immunity and neuronal autoimmunity. We hypothesize that T lymphocyte autoimmune dysfunction is involved in the pathogenesis of the paraneoplastic neurological syndromes, and that killer T cells are involved in the targeting and successful killing of tumor cells in these cancer patients. Furthermore, we postulate that this activity may provide a model for autoimmune brain disease. We will assess the immune responses in PND patients, correlate these with the clinical data (time course of disease, symptoms and signs, disability), and collect and archive clinical data, serum and cells from PND patients for current and future studies into the basic immune system phenomenon present in PND patients.
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients with paraneoplastic neurologic disease, diagnosed through the research lab of the PI, or from third party referrals in the NYC area.
Inclusion Criteria:
- Neurological disease which is suspected to be paraneoplastic
- No known active additional malignancy other than non-melanoma skin cancer
Exclusion Criteria:
- Known central nervous system (CNS) metastasis
- Known active additional malignancy
if leukapheresis: No known hepatitis B or C, HIV, or syphilis (by history or prior negative tests) no known IV drug users HgB > 8.5 WBC > 3,500 platelets > 100,000 INR < 2
if large blood draw (1/2 to 1 unit; children 3 ml/kg) in lieu of leukapheresis: no known IV drug users HgB > 10 WBC > 3,500 platelets > 100,000 INR < 2 if lumbar puncture: platelets > 120,000 INR < 1.2
Contacts and Locations| Contact: Mayu Frank, NP | 212-327-7454 | frankm@rockefeller.edu |
| United States, New York | |
| Rockefeller University Hospital | Recruiting |
| New York, New York, United States, 10021 | |
| Contact: Mayu Frank, NP 212-327-7443 frankm@rockefeller.edu | |
| Principal Investigator: Robert Darnell, MD, PHD | |
| Principal Investigator: | Robert Darnell, MD, PHD | Rockefeller University |
More Information
Additional Information:
No publications provided
| Responsible Party: | Rockefeller University |
| ClinicalTrials.gov Identifier: | NCT00327236 History of Changes |
| Other Study ID Numbers: | RDA-0148 |
| Study First Received: | May 17, 2006 |
| Last Updated: | December 4, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Rockefeller University:
|
Paraneoplastic Neurologic Syndromes |
Additional relevant MeSH terms:
|
Paraneoplastic Syndromes Paraneoplastic Syndromes, Nervous System Neoplasms Nervous System Neoplasms |
Neoplasms by Site Neurodegenerative Diseases Nervous System Diseases |
ClinicalTrials.gov processed this record on June 18, 2013