Clinical trial NCT00165542: A-protein Levels in Adult and Pediatric Brain Tumor Patients
Official title: Determination of A-Protein Levels in Adult and Pediatric Brain Tumor Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malignant Childhood Central Nervous System Neoplasm
Keywords: A-protein level
brain tumor
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: Brigham and Women's Hospital
First posted: 2005-09-14
Enrollment: 54
Sex: ALL
Maximum age (years): 77
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be identified at the time of presentation to their neurologist, neurosurgeon or oncologist

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: association between serum A-Protein level class and clinical status
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana Farber Cancer Institite
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Mark W Kieran, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Manley P, Li X, Turner C, Chi S, Zimmerman MA, Chordas C, Gordon A, Baker A, Ullrich NJ, Goumnerova L, Marcus K, Hoffman K, Kieran MW. A prospective, blinded analysis of A-PROTEIN (recoverin or CAR protein) levels in pediatric patients with central nervous system tumors. Pediatr Blood Cancer. 2009 Sep;53(3):343-7. doi: 10.1002/pbc.22017.