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Eligibility Screening and Tissue Procurement for the National Cancer Institute (NCI) Center for Cancer Research (CCR) Clinical Protocols


N/A
N/A
N/A
Open (Enrolling)
Both
Cancer, HIV Infection, Skin Disease

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Trial Information

Eligibility Screening and Tissue Procurement for the National Cancer Institute (NCI) Center for Cancer Research (CCR) Clinical Protocols


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.

Inclusion 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

Type of Study:

Observational

Study Design:

N/A

Principal Investigator

Caryn Steakley, R.N.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Institute (NCI)

Authority:

United States: Federal Government

Study ID:

010129

NCT ID:

NCT00026754

Start Date:

March 2001

Completion Date:

Related Keywords:

  • Cancer
  • HIV Infection
  • Skin Disease
  • Screening
  • Cancer
  • HIV Infection
  • Scans
  • Laboratory Tests
  • HIV
  • Skin Disorders
  • HIV Infections
  • Acquired Immunodeficiency Syndrome
  • Skin Diseases

Name

Location

National Institutes of Health Clinical Center, 9000 Rockville PikeBethesda, Maryland  20892