Ignite Creation Date:
2024-05-05 @ 7:07 PM
Last Modification Date:
2024-10-26 @ 9:44 AM
Study NCT ID:
NCT00608452
Status:
COMPLETED
Last Update Posted:
2009-11-13
First Post:
2008-01-23
Brief Title:
PrevalenceSignificance of Paraneoplastic Autoantibodies in Many Cancers
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
A Prospective Study of The Prevalence and Significance of Paraneoplastic Autoantibodies in Small Cell Lung Cancer and Cancer of The Breast Ovary Hodgkins Disease Neuroblastoma and Other Cancers
Status:
COMPLETED
Status Verified Date:
2009-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 ie 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
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 ie 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
Detailed Description:
Objectives
To determine prospectively the prevalence and specificity of anti-Hu and other paraneoplastic antibodies in patients with small cell lung cancer SCLC and other cancers including but not limited to ovarian cancer breast cancer and Hodgkins disease the prevalence of other autoimmune antibodies in patients with SCLC and other cancers including but not limited to anti-nuclear antibodies anti-P53 antibodies rheumatoid factor and anti-calcium channel antibodies the prevalence and significance of antibodies against a LEMS-related antigen MysBwhether the production of autoantibodies including anti-Hu antibodies is related to patient MHC phenotype
To examine tumor specimens and other available tissues sputum and bone marrow if possible for the presence of Hu antigen-expressing cells andor cells expressing other paraneoplastic antigenspatients with SCLC and other cancers for the development of neurologic signs paraneoplastic or otherwise
Attempts will be made to evaluate all patients at the time of initial consultation by the primary oncologist If this is not possible attempts will be made to obtain the neurological evaluation at the time of the next visit with the oncologist or in case of inpatients during the patients admission A complete history and neurologic examination will be performed at that time by the neurologist with documentation of signs and symptoms The patient will be given the Memorial Symptom Assessment Scale to complete see attached
At initial evaluation blood will be obtained for the following laboratory studies including but not limited to for children the amount of blood drawn will be no more than 5 cc per Kg for each visit A Rheumatoid Factor and Anti-nuclear anti-thyroglobulin anti-microsomal anti-Ro and antip53 antibodies B HLA Typing HLA-ABC IEF Class II DNA and lymphocyte analysis C Anti-neuronal antibodies including HuD HuC and HeI-N1 anti-Yo anti-Ri anti-Tr antibodies D LEMS-associated antibodies MysB antibodies
At follow-up approximately every 4 months appointments blood samples will be obtained for the following studies including but not limited to anti-neuronal antibodies HuC and HeI-N1 and LEMS-associated antibodies MysB antibodies
Tissue samples obtained at diagnosis or during the course of treatment tumor resection or biopsy sputum collections or bone marrow aspirations will be evaluated for the expression of Hu and other paraneoplastic antigens
As part of the study patients with positive paraneoplastic antibody serology will be requested to undergo a lumbar puncture for antibody determination of these antibodies cellcount and chemistry proteins glucose and IgG index in CSF In pediatric neuroblastoma patients with stage 4 neuroblastoma the lumbar puncture will be avoided since there is preliminary evidence suggesting increased risk for leptomeningeal dissemination Antibody positive patients will be offered quantitative sensory testing for evaluation of subclinical sensory neuronopathy This test analyzes the minimum increments of sensory stimuli cold hot and vibration required to be noticed by the patient and compares these results with known normal standard values The test is given by the clinical neurologist and does not cause any discomfort
Conventional nerve conduction studies or EMG are not required unless the patient has symptoms and signs of neuropathy or the patient is asymptomatic but the quantitative sensory test is abnormal In these situations nerve conduction and EMG studies of upper and lower extremities will be obtained All patients who undergo CSF analysis will be required to have a blood test glucose proteins and IgG to be compared with the CSF values and to obtain the IgG index a measurement of intrathecal synthesis of IgG
Patients with positive anti-Mys B antibody serology or with symptoms suggesting LEMS proximal weakness decreased or absent reflexes will be offered EMG nerve conduction studies and repetitive stimulation
A random sample of 20 of patients not presenting with positive anti-Hu serology will be offered quantitative sensory testing for evaluation of subclinical sensory neuropathy in order to serve as a control group Spinal fluid from patients who undergo lumbar puncture for reasons unrelated to anti-Hu serology results approximately 10-15 of patients will serve as a control for the spinal fluids obtained from seropositive patients In these patients a sample of blood will be obtained to measure glucose proteins IgG and IgG index
To determine prospectively the prevalence and specificity of anti-Hu and other paraneoplastic antibodies in patients with small cell lung cancer SCLC and other cancers including but not limited to ovarian cancer breast cancer and Hodgkins disease the prevalence of other autoimmune antibodies in patients with SCLC and other cancers including but not limited to anti-nuclear antibodies anti-P53 antibodies rheumatoid factor and anti-calcium channel antibodies the prevalence and significance of antibodies against a LEMS-related antigen MysBwhether the production of autoantibodies including anti-Hu antibodies is related to patient MHC phenotype
To examine tumor specimens and other available tissues sputum and bone marrow if possible for the presence of Hu antigen-expressing cells andor cells expressing other paraneoplastic antigenspatients with SCLC and other cancers for the development of neurologic signs paraneoplastic or otherwise
Attempts will be made to evaluate all patients at the time of initial consultation by the primary oncologist If this is not possible attempts will be made to obtain the neurological evaluation at the time of the next visit with the oncologist or in case of inpatients during the patients admission A complete history and neurologic examination will be performed at that time by the neurologist with documentation of signs and symptoms The patient will be given the Memorial Symptom Assessment Scale to complete see attached
At initial evaluation blood will be obtained for the following laboratory studies including but not limited to for children the amount of blood drawn will be no more than 5 cc per Kg for each visit A Rheumatoid Factor and Anti-nuclear anti-thyroglobulin anti-microsomal anti-Ro and antip53 antibodies B HLA Typing HLA-ABC IEF Class II DNA and lymphocyte analysis C Anti-neuronal antibodies including HuD HuC and HeI-N1 anti-Yo anti-Ri anti-Tr antibodies D LEMS-associated antibodies MysB antibodies
At follow-up approximately every 4 months appointments blood samples will be obtained for the following studies including but not limited to anti-neuronal antibodies HuC and HeI-N1 and LEMS-associated antibodies MysB antibodies
Tissue samples obtained at diagnosis or during the course of treatment tumor resection or biopsy sputum collections or bone marrow aspirations will be evaluated for the expression of Hu and other paraneoplastic antigens
As part of the study patients with positive paraneoplastic antibody serology will be requested to undergo a lumbar puncture for antibody determination of these antibodies cellcount and chemistry proteins glucose and IgG index in CSF In pediatric neuroblastoma patients with stage 4 neuroblastoma the lumbar puncture will be avoided since there is preliminary evidence suggesting increased risk for leptomeningeal dissemination Antibody positive patients will be offered quantitative sensory testing for evaluation of subclinical sensory neuronopathy This test analyzes the minimum increments of sensory stimuli cold hot and vibration required to be noticed by the patient and compares these results with known normal standard values The test is given by the clinical neurologist and does not cause any discomfort
Conventional nerve conduction studies or EMG are not required unless the patient has symptoms and signs of neuropathy or the patient is asymptomatic but the quantitative sensory test is abnormal In these situations nerve conduction and EMG studies of upper and lower extremities will be obtained All patients who undergo CSF analysis will be required to have a blood test glucose proteins and IgG to be compared with the CSF values and to obtain the IgG index a measurement of intrathecal synthesis of IgG
Patients with positive anti-Mys B antibody serology or with symptoms suggesting LEMS proximal weakness decreased or absent reflexes will be offered EMG nerve conduction studies and repetitive stimulation
A random sample of 20 of patients not presenting with positive anti-Hu serology will be offered quantitative sensory testing for evaluation of subclinical sensory neuropathy in order to serve as a control group Spinal fluid from patients who undergo lumbar puncture for reasons unrelated to anti-Hu serology results approximately 10-15 of patients will serve as a control for the spinal fluids obtained from seropositive patients In these patients a sample of blood will be obtained to measure glucose proteins IgG and IgG index
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None