This trial is active, not recruiting.

Condition malignant or benign lesions of the central nervous system
Sponsor Dana-Farber Cancer Institute
Collaborator Brigham and Women's Hospital
Start date June 1998
End date February 2004
Trial size 180 participants
Trial identifier NCT00165542, 98-137


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective

Primary Outcomes

The purpose of this study is to evaluate the usefulness of a molecule called "A-Protein" in the diagnosis and evaluation of patients with central nervous system disorders.
time frame: 24 months

Secondary Outcomes

To determine the sensitivity and specificity in pediatric malignant brain tumors; To better define the T ½ for this protein in patients status post initial tumor resection with a presumed gross total resection;
time frame: 24 months

Eligibility Criteria

Male or female participants up to 77 years old.

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.

Additional Information

Official title Determination of A-Protein Levels in Adult and Pediatric Brain Tumor Patients
Principal investigator Mark W Kieran, MD,PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2007.
Information provided to ClinicalTrials.gov by Dana-Farber Cancer Institute.