Primary or Metastatic Central Nervous System (CNS) TumorNCT00580463
Collection of Tumor Tissue, Blood and Spinal Fluid From Patients With Brain or Spine Tumors
An observational study of Primary or Metastatic Central Nervous System (CNS) Tumor, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Primary or Metastatic Central Nervous System (CNS) Tumor
- How many people
- 1,128 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2000to Mar 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The patient population will include adult and pediatric patients diagnosed with a primary or metastatic central nervous system tumor.
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
About this study
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.
Read the 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.
- Keywords
- central nervous system (CNS) tumor, tissue collection
- Medical subject headings
- Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
To establish a repository of CNS tumors or metastases to the CNS and related tissues for current or future studies.
Measured: conclusion of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2007 (estimated)
- Study startJan 2000
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary or Metastatic Central Nervous System (CNS) TumorStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Rockefeller University
- Investigators
- Philip Gutin, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00580463
- Sponsor's protocol ID
- 99-125
- Status last verified
- Mar 2009
- First submitted
- 20 Dec 2007
- Last updated
- 19 Mar 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collection of Tumor Tissue, Blood and Spinal Fluid From Patients With Brain or Spine Tumors
- ClinicalTrials.gov ID
- NCT00580463
- Acronym / sponsor ID
- 99-125
- Keywords
- central nervous system (CNS) tumor, tissue collection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,128 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Rockefeller University
- Study start
- Jan 2000
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 24 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The patient population will include adult and pediatric patients diagnosed with a primary or metastatic central nervous system tumor.
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2009.
- Memorial Sloan-Kettering Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philip Gutin, MD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary or Metastatic Central Nervous System (CNS) Tumor, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2009.