Malignant Childhood Central Nervous System Neoplasm Clinical Trial
Official title:
Determination of A-Protein Levels in Adult and Pediatric Brain Tumor Patients
| Verified date | November 2016 |
| Source | Dana-Farber Cancer Institute |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 54 |
| Est. completion date | August 2009 |
| Est. primary completion date | February 2004 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | N/A to 77 Years |
| Eligibility |
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. |
Observational Model: Case-Only, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| United States | Dana Farber Cancer Institite | Boston | Massachusetts |
| Lead Sponsor | Collaborator |
|---|---|
| Dana-Farber Cancer Institute | Brigham and Women's Hospital |
United States,
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 nervou — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | association between serum A-Protein level class and clinical status | 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. | 4 years | No |