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Prevalence+Significance of Paraneoplastic Autoantibodies in Many Cancers

This study is ongoing, but not recruiting participants.

Sponsored by: Memorial Sloan-Kettering Cancer Center
Information provided by: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00608452
  Purpose

You may have a type of cancer associated with "antineuronal antibodies" in your blood.

Antibodies are substances made by the immune system. They are used by the body to fight infections and other diseases. Antineuronal antibodies are antibodies that react with nerve cells but they also react with some tumors. We believe that the immune system makes these antibodies to fight the cancer. In some patients with these antibodies, the tumor is smaller than in patients who have no antibodies. Sometimes, with a very strong antibody test, patients may develop neurologic problems such as weakness, numbness or memory loss. One purpose of this study is to determine if a patient with cancer and a positive antineuronal antibody blood test has a smaller tumor and responds better to treatment than a patient with cancer and a negative test. Another purpose of this study is to determine whether patients with a positive antibody test develop neurologic problems such as weakness, numbness or memory loss.

We will measure your blood for several different kinds of antibodies in addition to antineuronal antibodies to determine if the presence of antibodies predicts "prognosis", i.e. smaller tumor and better response to treatment, or predicts the development of neurologic problems.

No tissue samples are required for this study. However, if tissue or sputum is obtained by your oncologist for diagnostic purposes, we will ask your doctors or the pathology department to provide us with samples of these specimens. This will not involve any additional surgery or discomfort to you.


Condition Intervention
Lung Cancer
Ovarian Cancer
Breast Cancer
Hodgkin's Disease
Neuroblastoma
Other: Symptom Assessment Scale

Genetics Home Reference related topics:   breast cancer   

MedlinePlus related topics:   Breast Cancer    Cancer    Hodgkin's Disease    Lung Cancer    Neuroblastoma    Ovarian Cancer   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Case-Only, Prospective
Official Title:   A Prospective Study of The Prevalence and Significance of Paraneoplastic Autoantibodies in Small Cell Lung Cancer and Cancer of The Breast, Ovary, Hodgkin's Disease, Neuroblastoma and Other Cancers

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • Blood samples for autoantibody determinations and HLA typing and clinical evaluations via Symptom Assessment Scale [ Time Frame: 15 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Biospecimen Description:

blood samples for autoantibody determinations and HLA typing


Estimated Enrollment:   180
Study Start Date:   July 1995
Estimated Study Completion Date:   July 2009
Estimated Primary Completion Date:   July 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts Assigned Interventions
1 Other: Symptom Assessment Scale
  • Memorial Symptom Assessment Scale
  • History and neurologic examination

Show detailed description  Show Detailed Description

  Eligibility
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample

Study Population

Patients with previous cancers or concurrent cancers. Patient has or may have, newly-diagnosed or recurrent SCLC, or mixed small cell/non small cell lung cancer, or neuroblastoma, or ovarian or breast cancer, or Hodgkin's disease in all cases confirmed by pathological review.


Criteria

Inclusion Criteria:

  • Patients with previous cancers or concurrent cancers. Patient has or may have, newly-diagnosed or recurrent SCLC, or mixed small cell/non small cell lung cancer, or neuroblastoma, or ovarian or breast cancer, or Hodgkin's disease in all cases confirmed by pathological review.

Exclusion Criteria:

  • Patient refusal to participate in follow-up clinical evaluations. For minors, parental or guardian refusal.
  • Patient refusal to provide blood samples for autoantibody determinations and HLA typing (total 4 tubes).
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00608452

Locations
United States, New York
Memorial Sloan Kettering Cancer Center    
      New York, New York, United States, 10065

Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center

Investigators
Principal Investigator:     Jerome Posner, MD     Memorial Sloan-Kettering Cancer Center    
  More Information


Memorial Sloan-Kettering Cancer Center  This link exits the ClinicalTrials.gov site
 

Responsible Party:   Memorial Sloan-Kettering Cancer Center ( Posner, Jerome, M /Principal Investigator )
Study ID Numbers:   95-046
First Received:   January 23, 2008
Last Updated:   January 23, 2008
ClinicalTrials.gov Identifier:   NCT00608452
Health Authority:   United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
Lung  
Ovarian  
Breast  
Hodgkin's  

Study placed in the following topic categories:
Thoracic Neoplasms
Hodgkin's disease
Neuroectodermal Tumors, Primitive
Gonadal Disorders
Hodgkin lymphoma, adult
Urogenital Neoplasms
Ovarian Diseases
Neuroblastoma
Genital Diseases, Female
Respiratory Tract Diseases
Lung Neoplasms
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Lymphoma
Hodgkin Disease
Breast Diseases
Endocrine Gland Neoplasms
Ovarian cancer
Immunoproliferative Disorders
Ovarian Neoplasms
Skin Diseases
Genital Neoplasms, Female
Endocrine System Diseases
Breast Neoplasms
Carcinoma, Small Cell
Lymphatic Diseases
Neuroectodermal Tumors
Autoantibodies
Lung Diseases
Endocrinopathy

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Immunologic Factors
Immune System Diseases
Physiological Effects of Drugs
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Pharmacologic Actions
Adnexal Diseases

ClinicalTrials.gov processed this record on November 03, 2008




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