ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Screening Patients for NCI Protocol Eligibility

This study is currently recruiting participants.
Verified by National Institutes of Health Clinical Center (CC), February 2006

Sponsored by: National Cancer Institute (NCI)
Information provided by: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00026754
  Purpose

The purpose of this protocol is to provide patients with adequate informed consent to understand that screening tests with minimal health risk will be performed to evaluate their eligibility for a research study. The protocol makes it clear that patients initial visit to the intramural clinical program may include screening studies that are not medically necessary for disease management, but are done purely for research purposes.

Patients with a known or suspected diagnosis of cancer, HIV infection, skin disorder or immunodeficiency who are being considered for enrollment in a National Cancer Institute intramural clinical research protocol will participate in this consent protocol. It informs patients of screening tests and procedures involving minimal risk that are done for research purposes only, including blood tests, electrocardiogram, standard X-rays (e.g., chest X-ray), bone films, computed tomography (CT), magnetic resonance imaging (MRI), and nuclear medicine studies. It explains that other eligibility screens that are more invasive and involve greater risk, such as a biopsy, will require separate consent.


Condition
Cancer
HIV Infection
Skin Disease

MedlinePlus related topics:   AIDS    Cancer    Skin Conditions   

U.S. FDA Resources

Study Type:   Observational
Official Title:   Eligibility Screening and Tissue Procurement for the National Cancer Institute (NCI) Center for Cancer Research (CCR) Clinical Protocols

Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment:   15000
Study Start Date:   March 2001
Estimated Study Completion Date:   February 2006

Detailed Description:

Patients who are being evaluated for Center for Cancer Research protocols will be entered onto this screening and tissue procurement protocol for eligibility screening and collection of tissue specimens. The screening tests and procedures that are required by the primary research protocols will be conducted in order to establish eligibility for these protocols. These procedures may include, but are not limited to, laboratory tests on blood, CSF, urine or other specimens; pulmonary function tests; TB skin tests; subspecialty consultations; molecular diagnostics on tumor tissues; radiographic and nuclear medicine studies, which may require the administration of contrast or a radioisotope tracer; and needle or open biopsies for diagnostic purposes. In some cases specific research samples required for the primary research protocol may be collected during the screening process in order to prevent us from having to subject the patient to a painful procedure on multiple occasions (e.g., bone marrow aspirations). These research specimens will be discarded or stored for future research purposes with the consent of the patient or his/her guardian, if the patient is not eligible for or elects not to enroll on the primary research protocol.

Performing invasive procedures for the sole purpose of obtaining tissue specimens or biological fluids for research purposes is often not ethically justifiable in human subjects, yet these specimens are needed to advance our knowledge on a variety of cancers. Therefore, it is critical to obtain tissue and biological fluid samples for future research when procedures (e.g., surgical excision, diagnostic biopsy) are performed for clinical indications in this population. Tissues and biological fluids that are obtained during or after the screening process or at any time during treatment and follow-up on a primary CCR research protocol will be stored. Residual biological fluids will be obtained during tests or procedures that are considered clinically indicated for the diagnosis or treatment of the patient's cancer or related disease. Tissues and biological fluids to be procured may include but are not limited to blood, serum, urine, tumor tissue, normal tissue, pleural fluid, CSF, saliva, bronchial alveolar lavage (BAL), and bone marrow. These specimens will be stored with patient identifiers, and a waiver will be obtained or IRB review will be requested prior to performing any research with these tissues or biological fluids.

Once a patient completes the screening process and is entered onto another study they may remain on study to allow for screening for other trials in the future or for the tissue procurement portion of this trial. This protocol will not serve as a vehicle for entry onto the Standard Care protocol (92-C0094).

  Eligibility
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria
  • INCLUSION CRITERIA:

Patients who are being evaluated for and treated on protocols within the CCR.

All patients or their legal guardians (if the patient is less than 18 years of age) must sign a document of informed consent indicating their understanding of the research nature and the risks of the procedures that will be performed to assess eligibility for research protocols.

Patients or their parents/guardians can refuse to participate in the tissue procurement portion of this protocol and still participate in the screening eligibility on CCR research trials.

A Durable Power of Attorney will be offered to all patients greater than 18 years of age who are potentially cognitively impaired.

EXCLUSION CRITERIA:

None

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00026754

Contacts
Contact: Susan L. Bakke, R.N.     bakkes@mail.nih.gov    
Contact: Susan L. Bakke, R.N.     3014355610     bakkes@mail.nih.gov    

Locations
United States, Maryland
National Cancer Institute (NCI)     Recruiting
      Bethesda, Maryland, United States, 20892

Sponsors and Collaborators
  More Information


NIH Clinical Center Detailed Web Page  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   010129, 01-C-0129
First Received:   November 14, 2001
Last Updated:   March 3, 2008
ClinicalTrials.gov Identifier:   NCT00026754
Health Authority:   United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Screening  
Cancer  
AIDS  
HIV  
Skin Disorders
Cancer
Screening

Study placed in the following topic categories:
Virus Diseases
Sexually Transmitted Diseases, Viral
Skin Diseases
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on October 10, 2008




Links to all studies - primarily for crawlers