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Screening Patients for NCI Protocol Eligibility
This study is currently recruiting participants.
Verified by National Institutes of Health Clinical Center (CC), August 2009
First Received: November 14, 2001   Last Updated: October 21, 2009   History of Changes
Sponsor: 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.

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Condition
Cancer
HIV Infection
Skin Disease

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

Resource links provided by NLM:


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

Estimated Enrollment: 15000
Study Start Date: March 2001
Estimated Primary Completion Date: January 2003 (Final data collection date for primary outcome measure)
Detailed Description:

Background:

  • Patients who are being evaluated for Center for Cancer Research protocols must be screened to determine whether they meet the eligibility criteria prior to enrollment.
  • 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.

Objectives:

  • Evaluate patient eligibility for participation in NCVCCR research protocols.
  • Collect results of screening test for use on subsequent research protocols as baseline ( e.g., pretreatment) values.
  • Collect specific research samples required for the primary research protocol as part of a screening test or procedure in order to avoid from having to subject the patient to a painful procedure on multiple occasions.
  • Procure residual tissues or fluids that are remaining from tests or procedures that are performed for clinical indications (e.g., diagnosis or treatment of the cancer) during the screening process or during treatment and follow-up on a primary NCVCCR research protocol. These specimens will be stored for future research studies.

Eligibility:

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

Design:

  • This protocol is not a research study
  • Screening tests and procedures that are required by the primary research protocols are conducted in order to establish eligibility for these protocols.
  • In some cases specific research samples required for the primary research protocol may be collected during the screening process in order to avoid from having to subject the patient to a painful procedure on multiple occasions.
  • 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.
  • Once a patient completes the screening process and is entered onto another study they may remain on this study to allow for screening for other trials in the future or for the tissue procurement portion of this trial.
  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 < 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 > 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: NCI Referral Office 1-888-NCI-1937 ncicssc@mail.nih.gov
Contact: Caryn Steakley, R.N. (301) 435-3685 steaklec@mail.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

Additional Information:
No publications provided

Study ID Numbers: 010129, 01-C-0129
Study First Received: November 14, 2001
Last Updated: October 21, 2009
ClinicalTrials.gov Identifier: NCT00026754     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Screening
Cancer
HIV Infection
Scans
Laboratory Tests
HIV
Skin Disorders
Cancer
Screening

Additional relevant MeSH terms:
Communicable Diseases
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Skin Diseases
Immune System Diseases
Acquired Immunodeficiency Syndrome
Infection
Immunologic Deficiency Syndromes
Virus Diseases
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections

ClinicalTrials.gov processed this record on November 27, 2009