Study of Patient Eligibility for Participation in Surgery Clinical Trials - Tabular View

Tracking Information

First Received Date ^ICMJE

July 11, 2001

Last Updated Date

July 7, 2009

Start Date ^ICMJE

August 1999

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00019799 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Study of Patient Eligibility for Participation in Surgery Clinical Trials

Official Title ^ICMJE

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 ^ICMJE

Interventional

Study Design ^ICMJE

Screening

Condition ^ICMJE

Unspecified Adult Solid Tumor, Protocol Specific

Intervention ^ICMJE

Other: physiologic testing

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

5000

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Contacts ^ICMJE

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00019799

Responsible Party

Study ID Numbers ^ICMJE

CDR0000067224, NCI-99-C-0128

Study Sponsor ^ICMJE

National Cancer Institute (NCI)

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Steven A. Rosenberg, MD, PhD

NCI - Surgery Branch

Information Provided By

National Cancer Institute (NCI)

Verification Date

July 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP