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A-protein Levels in Adult and Pediatric Brain Tumor Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00165542
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : November 23, 2016
Brigham and Women's Hospital
Information provided by (Responsible Party):
Mark W. Kieran, MD, PhD, Dana-Farber Cancer Institute

Brief Summary:
The purpose of this study is to evaluate the sensitivity and specificity of "A-PROTEIN" levels in patients with brain tumors. A-PROTEIN levels will be analyzed both pre and post treatment. Levels in blood and/or cerebrospinal fluid (CSF) will be analyzed and correlated with the underlying diagnosis and outcome.

Condition or disease Intervention/treatment
Malignant Childhood Central Nervous System Neoplasm Other: A PROTEIN level

Detailed Description:
  • Patients will be identified at the time of presentation to their neurologist, neurosurgeon or oncologist.
  • Blood or cerebrospinal fluid will be collected for this study only when they are being collected for other reasons before and after each surgery. Samples will also be collected after any event such as significant change in symptoms or radiographic progression.
  • Once the patients condition has been stabilized, samples will be take at regular intervals of >= 1 month. The duration of this study is 24 months.

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Study Type : Observational
Actual Enrollment : 54 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Determination of A-Protein Levels in Adult and Pediatric Brain Tumor Patients
Study Start Date : June 1998
Actual Primary Completion Date : February 2004
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Brain Tumors

Group/Cohort Intervention/treatment
All patients
A PROTEIN levels in all patients and with all tumor types.
Other: A PROTEIN level

Primary Outcome Measures :
  1. association between serum A-Protein level class and clinical status [ Time Frame: 4 years ]
    Serum samples were collected when patients were due for clinically indicated phlebotomy. Serum A-PROTEIN levels were determined using a competitive labeled antibody assay and patients were classified into 3 groups: negative <7pM, equivocal 7-9.9 pM and positive >/= 10 pM; Clinical status at the same time of the sample collection was established by MRI scans and patients grouped as either resected/decreased versus stable/increased. The relationship between clinical status and A-PROTEIN level was assessed using general estimating equations. Association was defined as a statistically significant p-value from the regression model.

Biospecimen Retention:   Samples With DNA
whole blood cerebrospinal fluid

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   up to 77 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients will be identified at the time of presentation to their neurologist, neurosurgeon or oncologist

Inclusion Criteria:

  • All patients with possible malignant or benign lesions of the central nervous system will be included.
  • There are no restrictions with respect to treatment protocols or prior therapy.
  • Patients will be identified after presentation to the neurosurgical, neurological or oncologic services at participating centers. Any patient with evidence of a central nervous system tumor will be eligible. Individuals without evidence of CNS tumors are also eligible, in order to provide blinded controls.
  • A signed informed consent will be requested and required for participation.
  • There is no age, sex, or ethnic origin restrictions in this protocol. Patients who choose not to participate in the study will continue to have their regular care as defined by their treating team. Patients who speak foreign languages are eligible as long a translator can be found to ensure proper consent has been obtained.

Exclusion Criteria: There are no exclusion criteria for this study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00165542

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United States, Massachusetts
Dana Farber Cancer Institite
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Dana-Farber Cancer Institute
Brigham and Women's Hospital
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Principal Investigator: Mark W Kieran, MD,PhD Dana-Farber Cancer Institute
Publications of Results:
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Responsible Party: Mark W. Kieran, MD, PhD, Principal Investigator, Dana-Farber Cancer Institute Identifier: NCT00165542    
Other Study ID Numbers: 98-137
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: November 23, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Mark W. Kieran, MD, PhD, Dana-Farber Cancer Institute:
A-protein level
brain tumor
Additional relevant MeSH terms:
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Brain Neoplasms
Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases