Prevalence+Significance of Paraneoplastic Autoantibodies in Many Cancers
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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 |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: 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 |
- 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
blood samples for autoantibody determinations and HLA typing
| Estimated Enrollment: | 121 |
| Study Start Date: | July 1995 |
| Study Completion Date: | November 2009 |
| Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| 1 |
Other: Symptom Assessment Scale
|
Show Detailed Description
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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.
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| United States, New York | |
| Memorial Sloan Kettering Cancer Center | |
| New York, New York, United States, 10065 | |
| Principal Investigator: | Jerome Posner, MD | Memorial Sloan-Kettering Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Posner, Jerome, M /Principal Investigator, Memorial Sloan-Kettering Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00608452 History of Changes |
| Other Study ID Numbers: | 95-046 |
| Study First Received: | January 23, 2008 |
| Last Updated: | November 12, 2009 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Memorial Sloan-Kettering Cancer Center:
|
Lung Ovarian Breast Hodgkin's |
Additional relevant MeSH terms:
|
Breast Neoplasms Hodgkin Disease Lung Neoplasms Neuroblastoma Ovarian Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Lymphoma Neoplasms by Histologic Type Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
Respiratory Tract Neoplasms Thoracic Neoplasms Lung Diseases Respiratory Tract Diseases Neuroectodermal Tumors, Primitive, Peripheral Neuroectodermal Tumors, Primitive Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Endocrine Gland Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female |
ClinicalTrials.gov processed this record on May 16, 2013