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| 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.
...
| 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 |
| Estimated Enrollment: | 15000 |
| Study Start Date: | March 2001 |
| Estimated Primary Completion Date: | January 2003 (Final data collection date for primary outcome measure) |
Background:
Objectives:
Eligibility:
- Patients who are being evaluated for and treated on protocols within the CCR.
Design:
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
are potentially cognitively impaired.
EXCLUSION CRITERIA:
None
Contacts and Locations| Contact: NCI Referral Office | 1-888-NCI-1937 | ncicssc@mail.nih.gov |
| Contact: Caryn Steakley, R.N. | (301) 435-3685 | steaklec@mail.nih.gov |
| United States, Maryland | |
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
| Bethesda, Maryland, United States, 20892 | |
More Information
| 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 |
|
Screening Cancer HIV Infection Scans Laboratory Tests |
HIV Skin Disorders Cancer Screening |
|
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 |