Clinical Trial: A-protein Levels in Adult and Pediatric Brain Tumor Patients

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Determination of A-Protein Levels in Adult and Pediatric Brain Tumor Patients

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 Summary:

  • 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.

Sponsor: Dana-Farber Cancer Institute

Current Primary Outcome: 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.


Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Dana-Farber Cancer Institute

Dates:
Date Received: September 12, 2005
Date Started: June 1998
Date Completion:
Last Updated: November 21, 2016
Last Verified: November 2016