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CompletedNCT00327236Updated Apr 10, 2019

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

An observational study in Paraneoplastic Syndromes, sponsored by Rockefeller University. Completed at 1 site in United States. Open to participants aged 1 Year and older. Per ClinicalTrials.gov, last updated 2019-04-10.

Sponsored by Rockefeller University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
109
Ages
1 Year and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Paraneoplastic Syndromes

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Keywords

  • Paraneoplastic Neurologic Syndromes
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In context

Syndrome

9,217 studies on the registry are indexed under Syndrome; 1,031 are open to participants now.

This study's enrollment of 109 is close to the median of 102 across 2,209 observational studies indexed under Syndrome.

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Lead sponsor

Rockefeller University is the lead sponsor of 120 studies on the registry; 3 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 6 (43%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
1 Year and older
Sexes eligible
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.

Inclusion criteria

  • Neurological disease which is suspected to be paraneoplastic
  • No known active additional malignancy other than non-melanoma skin cancer

Exclusion criteria

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

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
109 participants (actual)
Biospecimen retention
Samples with dna
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What researchers measure

Primary outcomes

  1. Immunologic responses to tumor antigens in vitro

    ELISPOT

    Time frame: throughout study

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Study locations

1 site
  • Rockefeller University Hospital
    New York, New York 10021, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 10, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00327236
Lead sponsor
Rockefeller University
Responsible party
Sponsor
First posted
May 18, 2006
Start date
Jan 1995
Primary completion
Feb 2018
Completion
Feb 2018
Last update
Apr 10, 2019

Study contacts

Robert Darnell, MD, PHD
principal investigator · Rockefeller University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

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