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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in United States

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
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 groups in NCT00608452
Study groupRoleWhat they receive
1Not described
Receives: Other: Symptom Assessment Scale

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

  1. First posted6 Feb 2008 (estimated)
  2. Study startJul 1995
  3. Primary completionNov 2009
  4. Study completionNov 2009

Resources

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)
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

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.

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