Clinical trial · Observational
A-protein Levels in Adult and Pediatric Brain Tumor Patients
Determination of A-Protein Levels in Adult and Pediatric Brain Tumor Patients
NCT00165542CI-TRIAL-00024889completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Childhood Central Nervous System Neoplasm | Childhood Malignant Central Nervous System Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| A PROTEIN level | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- All patients
- description
- A PROTEIN levels in all patients and with all tumor types.
- interventionNames
- Other: A PROTEIN level
Primary outcomes (1)
- measure
- association between serum A-Protein level class and clinical status
- timeFrame
- 4 years
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 77 Years
Show eligibility criteria text
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.
References
Publications (1)
- RESULTManley 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. PMID 19422022