Collection of Tumor Tissue, Blood and Spinal Fluid From P... | NCT00580463

Studies
Collection of Tumor Tissue, Blood and Spinal Fluid From Patients With Brain or Spine Tumors

NCT00580463

Sponsor

Memorial Sloan Kettering Cancer Center

Status

Completed

Last Update Posted

Mar 19, 2009Estimated

Enrollment

1,128Actual

Phase

Not provided

Conditions

Primary or Metastatic Central Nervous System (CNS) Tumor

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2000

Primary Completion Date

Mar 2009Actual

Completion Date

Mar 2009Actual

First Submitted Date

Dec 20, 2007

First Submission Date that Met QC Criteria

Dec 20, 2007

First Posted Date

Dec 24, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 18, 2009

Last Update Posted Date

Mar 19, 2009Estimated

Name	Class
Rockefeller University	OTHER

Description Module

Brief 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. 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

1,128Actual

Measure	Description	Time Frame
To establish a repository of CNS tumors or metastases to the CNS and related tissues for current or future studies.		conclusion of the study

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

The patient population will include adult and pediatric patients diagnosed with a primary or metastatic central nervous system tumor.

Sampling Method

Non-Probability Sample