Lung CancerNCT00608452
Prevalence+Significance of Paraneoplastic Autoantibodies in Many Cancers
An observational study of Lung Cancer and Ovarian Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lung Cancer, Ovarian Cancer, Breast Cancer
- What is being tested?
- Symptom Assessment Scale
- How many people
- 121 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 1995to Nov 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
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
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.
Read more
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.
Read the 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 Hodgkin's 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 (MysB)/whether 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, and/or cells expressing other paraneoplastic antigens/patients 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 patient's 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
- Conditions
- Lung Cancer, Ovarian Cancer, Breast Cancer, Hodgkin's Disease, Neuroblastoma
- Being tested
- Symptom Assessment Scale
- Keywords
- Lung, Ovarian, Breast, Hodgkin's
- Medical subject headings
- Lung Neoplasms, Ovarian Neoplasms, Breast Neoplasms, Hodgkin Disease, Neuroblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Symptom Assessment ScaleOther
- Memorial Symptom Assessment Scale
- History and neurologic examination
| Study group | Role | What they receive |
|---|---|---|
| 1 | Not described Receives: Other: Symptom Assessment Scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood samples for autoantibody determinations and HLA typing and clinical evaluations via Symptom Assessment Scale
Measured: 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2008 (estimated)
- Study startJul 1995
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 121 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Investigators
- Jerome Posner, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00608452
- Sponsor's protocol ID
- 95-046
- Status last verified
- Nov 2009
- First submitted
- 23 Jan 2008
- Last updated
- 13 Nov 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00608452
- Acronym / sponsor ID
- 95-046
- Conditions
- Lung Cancer, Ovarian Cancer, Breast Cancer, Hodgkin's Disease, Neuroblastoma
- Keywords
- Lung, Ovarian, Breast, Hodgkin's
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 121 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- Jul 1995
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 6 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 Hodgkin's 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 (MysB)/whether 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, and/or cells expressing other paraneoplastic antigens/patients 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 patient's 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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: Symptom Assessment Scale |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Symptom Assessment Scale* Memorial Symptom Assessment Scale * History and neurologic examination | Other | 1 |
Primary outcome
Blood samples for autoantibody determinations and HLA typing and clinical evaluations via Symptom Assessment Scale
Time frame: 15
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2009.
- Memorial Sloan-Kettering Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jerome Posner, MD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer and Ovarian Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood samples for autoantibody determinations and HLA typing and clinical evaluations via Symptom Assessment Scale (time frame: 15). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2009.