Screening Patients for NCI Protocol Eligibility

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00026754
First received: November 14, 2001
Last updated: March 14, 2014
Last verified: January 2014
  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

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
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 NCI/CCR 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 NCI/CCR 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Contacts
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
Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office    (888) NCI-1937      
Sponsors and Collaborators
Investigators
Principal Investigator: Caryn Steakley, R.N. National Cancer Institute (NCI)
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00026754     History of Changes
Other Study ID Numbers: 010129, 01-C-0129
Study First Received: November 14, 2001
Last Updated: March 14, 2014
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

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

ClinicalTrials.gov processed this record on September 18, 2014