- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00580463
Collection of Tumor Tissue, Blood and Spinal Fluid From Patients With Brain or Spine Tumors
March 18, 2009 updated by: Memorial Sloan Kettering Cancer Center
The purpose of the study is to collect samples of brain or spine tumors.
Memorial Sloan-Kettering Cancer Center would then store them for use by researchers who study brain or spine cancer and try to find better ways of treating it.
We will also collect blood and spinal fluid from patients with brain or spine tumors.
The blood and spinal fluids are also used for research studies of cancer and its treatment.
Study Overview
Status
Completed
Detailed Description
The main objective of the protocol is the establishment of a repository of central nervous system (CNS) tumors or metastases to the CNS and related tissues as an invaluable resource for current or future research studies of the etiology, pathogenesis and treatment of human central nervous system tumors.
The database will be established through the intra-operative acquisition of brain or spine tumors as well as the collection of blood and spinal fluids from consenting CNS tumor patients.
Study Type
Observational
Enrollment (Actual)
1128
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
-
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New York
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New York, New York, United States, 10065
- Memorial Sloan-Kettering Cancer Center
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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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
The patient population will include adult and pediatric patients diagnosed with a primary or metastatic central nervous system tumor.
Description
Inclusion Criteria:
- For acquisition of intra-operative brain or spine tumor specimens, blood specimens and spinal fluid specimens, all patients who undergo surgery for resection or biopsy qualify for inclusion in this protocol.
- If spinal fluid is not accessed as part of the operative procedure, it will not be collected.
- All patients must be under the care of one or more members of the MSKCC CNS disease management team at the time of tissue acquisition. Patients may have been previously diagnosed and/or treated at another institution.
- Subjects are eligible regardless of sex, age or race.
- Parental or guardian consents will be obtained in the case of minors (less than 18 years of age)
Exclusion Criteria:
- Patients or their guardians, in case of a minor, may choose to be excluded at any time.
- If a patient, or guardian, decides to withdraw after some or all of the tissues have been collected, such tissues will be destroyed at their request.
- Patients or their guardians will be counseled at the time of obtaining their consent, of the possibility of withdrawing from the protocol.
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
- Observational Models: Case-Only
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
To establish a repository of CNS tumors or metastases to the CNS and related tissues for current or future studies.
Time Frame: conclusion of the study
|
conclusion of the study
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Philip Gutin, MD, Memorial Sloan Kettering Cancer Center
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.
Helpful Links
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
January 1, 2000
Primary Completion (Actual)
March 1, 2009
Study Completion (Actual)
March 1, 2009
Study Registration Dates
First Submitted
December 20, 2007
First Submitted That Met QC Criteria
December 20, 2007
First Posted (Estimate)
December 24, 2007
Study Record Updates
Last Update Posted (Estimate)
March 19, 2009
Last Update Submitted That Met QC Criteria
March 18, 2009
Last Verified
March 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 99-125
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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