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

This study is currently recruiting participants.
Verified January 2017 by Rockefeller University
Sponsor:
ClinicalTrials.gov Identifier:
NCT00327236
First Posted: May 18, 2006
Last Update Posted: January 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Rockefeller University
  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

Further study details as provided by Rockefeller University:

Primary Outcome Measures:
  • Immunologic responses to tumor antigens in vitro [ Time Frame: throughout study ]

Biospecimen Retention:   Samples With DNA
serum, cells)

Estimated Enrollment: 100
Study Start Date: January 1995
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year and older   (Child, Adult, Senior)
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
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


Contacts
Contact: Mayu Frank, NP 212-327-7454 frankm@rockefeller.edu

Locations
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         
Sponsors and Collaborators
Rockefeller University
Investigators
Principal Investigator: Robert Darnell, MD, PHD Rockefeller University
  More Information

Responsible Party: Rockefeller University
ClinicalTrials.gov Identifier: NCT00327236     History of Changes
Other Study ID Numbers: RDA-0148
First Submitted: May 17, 2006
First Posted: May 18, 2006
Last Update Posted: January 5, 2017
Last Verified: January 2017

Keywords provided by Rockefeller University:
Paraneoplastic Neurologic Syndromes

Additional relevant MeSH terms:
Syndrome
Paraneoplastic Syndromes
Paraneoplastic Syndromes, Nervous System
Disease
Pathologic Processes
Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neurodegenerative Diseases
Nervous System Diseases