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A-protein Levels in Adult and Pediatric Brain Tumor Patients

This study has been completed.
Sponsor:
Collaborator:
Brigham and Women's Hospital
Information provided by (Responsible Party):
Mark W. Kieran, MD, PhD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00165542
First received: September 12, 2005
Last updated: November 21, 2016
Last verified: November 2016
  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 Intervention
Malignant Childhood Central Nervous System Neoplasm
Other: A PROTEIN level

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:


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

Primary Outcome Measures:
  • association between serum A-Protein level class and clinical status [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    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.


Biospecimen Retention:   Samples With DNA
whole blood cerebrospinal fluid

Enrollment: 54
Study Start Date: June 1998
Study Completion Date: August 2009
Primary Completion Date: February 2004 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
All patients
A PROTEIN levels in all patients and with all tumor types.
Other: A PROTEIN level

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   (Child, Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Publications:
Responsible Party: Mark W. Kieran, MD, PhD, Principal Investigator, 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: November 21, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No

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

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

ClinicalTrials.gov processed this record on December 09, 2016