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Collecting and Storing Tissue and Fluid Samples From Patients Receiving Standard Care at the National Cancer Institute
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), June 2009
First Received: May 9, 2009   Last Updated: June 16, 2009   History of Changes
Sponsored by: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00898625
  Purpose

RATIONALE: Collecting and storing samples of tumor tissue, blood, urine, and cerebrospinal fluid from patients to test in the laboratory may help the study of cancer.

PURPOSE: This study is collecting and storing tissue and fluid samples from patients receiving standard care at the National Cancer Institute.


Condition Intervention
Unspecified Adult Solid Tumor, Protocol Specific
Procedure: observation

Study Type: Observational
Official Title: Medical Oncology Care in the NCI, Center for Cancer Research

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Collection and storage of biological samples [ Designated as safety issue: No ]

Estimated Enrollment: 1000
Study Start Date: April 2005
Detailed Description:

OBJECTIVES:

  • Collect and store biological samples from patients at the National Cancer Institute not currently enrolled in an active research study while providing standard care treatment and medical follow up.

OUTLINE: Patients are observed and receive standard medical care if necessary.

Biological samples, including tumor tissue, surgical tissue, blood, urine, and cerebrospinal fluid are collected during usual care and stored.

PROJECTED ACCRUAL: A total of 1,000 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Meets 1 of the following criteria:

    • Enrolled in a Center for Cancer Research (CCR) nontreatment research study and requires standard of care therapy
    • Eligible for a CCR research study in the near future but requires cancer therapy prior to enrollment
    • Standard of care therapy is requested through the Medical Oncology Clinical Research Unit (MOCRU) consult service
    • Treatment of cancer or risk of cancer would add significant value to the Medical Oncology fellowship training program
    • Previously enrolled in National Cancer Institute (NCI) trials in which important scientific endpoints, including natural history of the disease and late toxicities, were collected
    • Medical welfare could be seriously compromised by referral back to the community, such as rare or complex disease where community treatment is inadequate or adequate community resources are unavailable
    • Received majority of prior specialized medical care on research protocols at CCR and approaching the end of the natural history of disease
    • Diagnosed with cancer or HIV, or at risk for cancer or HIV, and cancer treatment or management at the NCI is requested via the MOCRU
    • CCR investigator decides it is in the best interest of the patient and NCI for patient to be enrolled on protocol and continue to receive care and follow up within the MOCRU

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • Not specified
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00898625

Locations
United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office Recruiting
Bethesda, Maryland, United States, 20892-1182
Contact: Clinical Trials Office - Warren Grant Magnusen Clinical Center     888-NCI-1937        
Sponsors and Collaborators
Investigators
Principal Investigator: Giuseppe Giaccone, MD, PhD NCI - Medical Oncology Branch
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000389516, NCI-04-C-0165
Study First Received: May 9, 2009
Last Updated: June 16, 2009
ClinicalTrials.gov Identifier: NCT00898625     History of Changes
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
unspecified adult solid tumor, protocol specific

ClinicalTrials.gov processed this record on September 11, 2009