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Home > "S" Clinical Trials Conditions > Screening Patients for NCI Protocol Eligibility  Screening Patients for NCI Protocol Eligibility
Screening Patients for NCI Protocol Eligibility
For Condition: Skin Disease,Cancer,HIV Infection
Status: Recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: 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.
Details: 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:
Study Type: Observational, Screening
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry 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:
Total Enrollment: 15000
Location and Contact Information:
National Cancer Institute (NCI) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Susan Bakke 3014355610
Additional Information:
Study ID Numbers: 010129; 01-C-0129
Study Start Date: March 21, 2001
Record last reviewed: March 1, 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00026754
Other Skin Disease Studies:
1. Follow-up Protocol for Patients with Cancer/AIDS/Skin Disease
2. Continuing Care and Treatment for Patients with Cancer/AIDS/Skin Disease
3. The Acquisition of Blood and Skin Samples from Normal Volunteers to Support Research Activities on Dermatologic Diseases
4. Structure of the Herpes Simplex Virus Receptor
5. Screening Patients for NCI Protocol Eligibility
Related Studies:
Other Skin Disease Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Screening Patients for NCI Protocol Eligibility
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