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The Study of Immune Cell (T Cell) Activity in Patients With Paraneoplastic Neurologic Syndromes

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ClinicalTrials.gov Identifier: NCT00327236
Recruitment Status : Completed
First Posted : May 18, 2006
Last Update Posted : April 10, 2019
Sponsor:
Information provided by (Responsible Party):
Rockefeller University

Study Description
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Brief Summary:
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 or disease
Paraneoplastic Syndromes

Detailed Description:
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.
Study Design
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Study Type : Observational
Actual Enrollment : 109 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Killer T Cell Activity in the Paraneoplastic Neurologic Syndromes
Study Start Date : January 1995
Actual Primary Completion Date : February 2018
Actual Study Completion Date : February 2018
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Immunologic responses to tumor antigens in vitro [ Time Frame: throughout study ]
    ELISPOT


Biospecimen Retention:   Samples With DNA
serum, cells)

Eligibility Criteria
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Ages Eligible for Study:   1 Year and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with paraneoplastic neurologic disease, diagnosed through the research lab of the PI, or from third party referrals in the NYC area.
Criteria

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
  • No pulmonary disease which limits daily activities

if leukapheresis: must be 14 or older 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 must be 14 or older

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00327236


Locations
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United States, New York
Rockefeller University Hospital
New York, New York, United States, 10021
Sponsors and Collaborators
Rockefeller University
Investigators
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Principal Investigator: Robert Darnell, MD, PHD Rockefeller University
More Information
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Responsible Party: Rockefeller University
ClinicalTrials.gov Identifier: NCT00327236    
Other Study ID Numbers: RDA-0148
First Posted: May 18, 2006    Key Record Dates
Last Update Posted: April 10, 2019
Last Verified: April 2019
Keywords provided by Rockefeller University:
Paraneoplastic Neurologic Syndromes
Additional relevant MeSH terms:
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Paraneoplastic Syndromes
Paraneoplastic Syndromes, Nervous System
Syndrome
Disease
Pathologic Processes
 Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neurodegenerative Diseases
Nervous System Diseases