A-protein Levels in Adult and Pediatric Brain Tumor Patients

November 21, 2016 updated by: Mark W. Kieran, MD, PhD, Dana-Farber Cancer Institute

Determination of A-Protein Levels in Adult and Pediatric Brain Tumor Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

54

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Dana Farber Cancer Institite

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 77 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
All patients
A PROTEIN levels in all patients and with all tumor types.
Other: A PROTEIN level

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
association between serum A-Protein level class and clinical status
Time Frame: 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.
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dana-Farber Cancer Institute

Collaborators

Brigham and Women's Hospital

Investigators

  • Principal Investigator: Mark W Kieran, MD,PhD, Dana-Farber Cancer Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 1998

Primary Completion (Actual)

February 1, 2004

Study Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 14, 2005

Study Record Updates

Last Update Posted (Estimate)

November 23, 2016

Last Update Submitted That Met QC Criteria

November 21, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 98-137

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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