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Study of Patient Eligibility for Participation in Surgery Clinical Trials

This study is currently recruiting participants.
Study NCT00019799.   Last updated on October 18, 2008.   Information provided by National Cancer Institute (NCI)

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Descriptive Information Fields
Brief Title  Study of Patient Eligibility for Participation in Surgery Clinical Trials
Official Title  Evaluation for NCI Surgery Branch Clinical Research Protocols
Brief Summary

RATIONALE: Evaluating patients for eligibility in clinical trials may help doctors plan more effective surgical treatment for patients who have cancer.

PURPOSE: This clinical trial is studying patients to determine if they are eligible for surgery clinical trials.

Detailed Description

OBJECTIVES:

  • Evaluate patient eligibility for participation in NCI Surgery Branch protocols.
  • Permit standard therapy for patients ineligible for active Surgery Branch protocols who present novel or unique clinical training opportunity or conditions requiring immediate intervention in order to avoid compromising patient's health.

OUTLINE: Patients undergo various diagnostic procedures and clinical testing to determine protocol eligibility. The testing and procedures may include HLA blood typing, hepatitis screen, HIV serology, fine-needle aspiration, open incisional or excisional biopsies, leukapheresis, arteriogram, laparoscopy, various nuclear medicine and imaging scans with or without contrast dye, or pulmonary function tests.

PROJECTED ACCRUAL: A total of 5,000 patients will be accrued for this study within 5 years.

Study Phase
Study Type  Interventional
Study Design  Screening
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Unspecified Adult Solid Tumor, Protocol Specific
Intervention  Procedure: physiologic testing
MEDLINE PMIDs
Links Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  5000
Start Date  August 1999
Completion Date
Eligibility Criteria 

DISEASE CHARACTERISTICS:

  • Biopsy proven or suspected malignant disease

PATIENT CHARACTERISTICS:

Age:

  • 16 and over

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • Not specified

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Not specified

Other

  • No concurrent therapy unless ineligible for Surgery Branch protocol and standard therapy deemed to be in best interest of patient and suitable for training needs of Surgery Branch staff
Gender Both
Ages 16 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00019799
Organization ID CDR0000067224
Secondary IDs †† NCI-99-C-0128
Study Sponsor  NCI - Center for Cancer Research-Medical Oncology
Collaborators †† National Cancer Institute (NCI)
Investigators 
Study Chair:     Steven A. Rosenberg, MD, PhD     NCI - Surgery Branch    
Information Provided By National Cancer Institute (NCI)
Verification Date April 2008
First Received Date  July 11, 2001
Last Updated Date October 18, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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