A-protein Levels in Adult and Pediatric Brain Tumor Patients

Completed

• Conditions: Malignant Childhood Central Nervous System Neoplasm
• Interventions: Other: A PROTEIN level

• Registration Number: NCT00165542
• Lead Sponsor: Dana-Farber Cancer Institute

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 1998-06
• Primary Completion: 2004-02
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-14
• Study Completion: 2009-08
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-21
• Last Update Posted: 2016-11-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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.

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Exclusion Criteria

There are no exclusion criteria for this study.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
All patients	A PROTEIN level	A PROTEIN levels in all patients and with all tumor types.

Primary Outcome Measures

Name	Time	Method
association between serum A-Protein level class and clinical status	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.

Trial Locations

Locations (1)

Dana Farber Cancer Institite; 🇺🇸 Boston, Massachusetts, United States