NCT00327236

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
109

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 1995

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1995

Completed
11.4 years until next milestone

First Submitted

Initial submission to the registry

May 17, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 18, 2006

Completed
11.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

April 10, 2019

Status Verified

April 1, 2019

Enrollment Period

23.1 years

First QC Date

May 17, 2006

Last Update Submit

April 9, 2019

Conditions

Paraneoplastic Syndromes

Keywords

Paraneoplastic Neurologic Syndromes

Outcome Measures

Primary Outcomes (1)

  • Immunologic responses to tumor antigens in vitro

    ELISPOT

    throughout study

Eligibility Criteria

Age1 Year+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rockefeller University Hospital

New York, New York, 10021, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

serum, cells)

MeSH Terms

Conditions

Paraneoplastic SyndromesParaneoplastic Syndromes, Nervous System

Condition Hierarchy (Ancestors)

NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeurodegenerative DiseasesNervous System Diseases

Study Officials

  • Robert Darnell, MD, PHD

    Rockefeller University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 17, 2006

First Posted

May 18, 2006

Study Start

January 1, 1995

Primary Completion

February 1, 2018

Study Completion

February 1, 2018

Last Updated

April 10, 2019

Record last verified: 2019-04

Locations

US(1)