Eligibility Screening and Tissue Procurement for the NIH Intramural Research Program Clinical Protocols
| Status: | Recruiting |
|---|---|
| Conditions: | Breast Cancer, Lung Cancer, Prostate Cancer, Skin Cancer, Cancer, Cancer, Skin and Soft Tissue Infections, Infectious Disease, HIV / AIDS |
| Therapuetic Areas: | Dermatology / Plastic Surgery, Immunology / Infectious Diseases, Oncology |
| Healthy: | No |
| Age Range: | Any - 100 |
| Updated: | 3/24/2019 |
| Start Date: | January 14, 2004 |
| Contact: | Caryn Steakley, R.N. |
| Email: | steaklec@mail.nih.gov |
| Phone: | (240) 760-6070 |
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.
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.
Background:
- Patients and healthy volenteers who are being evaluated for NIH Intramural Research
Program (IRP) 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. Invasive procedures will not be
performed on healthy volunteers.
Objectives:
- Evaluate patient or healthy volunteer eligibility for participation in NIH IRP 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 research protocol.
These specimens will be stored for future research studies.
Eligibility:
- Patients and healthy volunteers who are being evaluated for and treated on protocols within
the NIH IRP.
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 NIH IRP 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 or healthy volunteer completes the screening process and is either
enrolled onto another NIH study or is returned to the care of their local physician they
will be taken off study.
- Patients and healthy volenteers who are being evaluated for NIH Intramural Research
Program (IRP) 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. Invasive procedures will not be
performed on healthy volunteers.
Objectives:
- Evaluate patient or healthy volunteer eligibility for participation in NIH IRP 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 research protocol.
These specimens will be stored for future research studies.
Eligibility:
- Patients and healthy volunteers who are being evaluated for and treated on protocols within
the NIH IRP.
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 NIH IRP 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 or healthy volunteer completes the screening process and is either
enrolled onto another NIH study or is returned to the care of their local physician they
will be taken off study.
- INCLUSION CRITERIA:
- Patients and healthy volunteers who are being evaluated for protocols within the NIH
Intramural Research Program.
- All patients, healthy volunteers, their parent/guardians orLegally Authorized
Representative (LAR) 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, healthy volunteers, their parents/guardians or LAR can refuse to participate
in the tissue procurement portion of this protocol and still participate in the
screening eligibility for NIH IRP research trials
EXCLUSION CRITERIA:
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
Phone: (888) NCI-1937
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