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A-protein Levels in Adult and Pediatric Brain Tumor Patients

NCT ID: NCT00165542

Last Updated: 2016-11-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

54 participants

Study Classification

OBSERVATIONAL

Study Start Date

1998-06-30

Study Completion Date

2009-08-31

Brief Summary

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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

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* 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.

Conditions

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Malignant Childhood Central Nervous System Neoplasm

Keywords

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A-protein level brain tumor

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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All patients

A PROTEIN levels in all patients and with all tumor types.

A PROTEIN level

Intervention Type OTHER

Interventions

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A PROTEIN level

Intervention Type OTHER

Eligibility Criteria

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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.
Maximum Eligible Age

77 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Brigham and Women's Hospital

OTHER

Sponsor Role collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role lead

Responsible Party

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Mark W. Kieran, MD, PhD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mark W Kieran, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

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Dana Farber Cancer Institite

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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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 nervous system tumors. Pediatr Blood Cancer. 2009 Sep;53(3):343-7. doi: 10.1002/pbc.22017.

Reference Type RESULT
PMID: 19422022 (View on PubMed)

Other Identifiers

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98-137

Identifier Type: -

Identifier Source: org_study_id