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A-Protein Levels in Adult and Pediatric Brain Tumor Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2007 by Dana-Farber Cancer Institute.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Brigham and Women's Hospital
Information provided by:
Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00165542
First received: September 12, 2005
Last updated: December 21, 2007
Last verified: December 2007
History of Changes
  Purpose

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.


Condition
Malignant or Benign Lesions of the Central Nervous System

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Determination of A-Protein Levels in Adult and Pediatric Brain Tumor Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • The purpose of this study is to evaluate the usefulness of a molecule called "A-Protein" in the diagnosis and evaluation of patients with central nervous system disorders. [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine the sensitivity and specificity in pediatric malignant brain tumors; To better define the T ½ for this protein in patients status post initial tumor resection with a presumed gross total resection; [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

whole blood cerebrospinal fluid


Enrollment: 180
Study Start Date: June 1998
Estimated Study Completion Date: February 2010
Primary Completion Date: February 2004 (Final data collection date for primary outcome measure)
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.
  Eligibility

Ages Eligible for Study:   up to 77 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients will be identified at the time of presentation to their neurologist, neurosurgeon or oncologist

Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00165542

Locations
United States, Massachusetts
Dana Farber Cancer Institite
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Investigators
Principal Investigator: Mark W Kieran, MD,PhD Dana-Farber Cancer Institute
  More Information

No publications provided

Responsible Party: Mark Kieran, MD, PhD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00165542     History of Changes
Other Study ID Numbers: 98-137
Study First Received: September 12, 2005
Last Updated: December 21, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:
A-protein level
brain tumor

Additional relevant MeSH terms:
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
 Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on June 18, 2013