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Completed

NCT Number: NCT00327236

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

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.

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Key information

Age range

1 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Rockefeller University Hospital

New York, 10021, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Immunologic responses to tumor antigens in vitro

    Time frame: throughout study

    ELISPOT

Sponsors and collaborators

Lead sponsor

Rockefeller University

Other

Registry information

Official study title

Killer T Cell Activity in the Paraneoplastic Neurologic Syndromes

Important dates

Study start
1995
Primary completion
2018
Study completion
2018
First posted
May 18, 2006
Registry last updated
Apr 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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