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Collection of Blood, Bone Marrow, Tumor, or Tissue Samples From Patients With HIV Infection, KSHV Infection, Viral-Related Pre-Malignant Lesions, and/or Cancer


N/A
18 Years
N/A
Open (Enrolling)
Both
HIV Infection, Kaposi's Sarcoma

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Trial Information

Collection of Blood, Bone Marrow, Tumor, or Tissue Samples From Patients With HIV Infection, KSHV Infection, Viral-Related Pre-Malignant Lesions, and/or Cancer


BACKGROUND: A number of important scientific advances can be made through the study of
blood, bone marrow, tumor, or other tissue samples from patients with HIV infection,
infection with Kaposi's sarcoma associated herpesvirus (KSHV), infection with other
oncogenic viruses, or cancer. This protocol provides a mechanism to effect a variety of such
studies.

OBJECTIVES: Acquisition of serum, circulating cells, bone marrow, and tumor or normal tissue
samples from patients with HIV infection, KSHV infection, or with cancer.

ELIGIBILITY: Eligibility criteria include age 18 years or older and at least one of the
following: Exposure risk to HIV, KSHV, or HPV; HIV seropositive; KSHV seropositive; EBV
seropositive; HTLV-1 seropositive; malignancy, Castleman's disease, or skin lesions with
appearance of Kaposi's sarcoma; or cervical or anal intraepithelial lesion.

DESIGN: Blood samples may be collected at the initial visit, and at follow-up visits. Tumor
samples may be obtained by fine needle aspirate, by removal of pleural or peritoneal fluid,
by skin punch biopsy, or by excisional biopsy, providing the tumor is accessible with
minimal risk to the patients. Specific risks will be described in a separate consent to be
obtained at the time of the biopsy. Samples will be studied in the HIV and AIDS Malignancy
Branch, CCR, NCI; laboratories in NCI-Frederick; or those of collaborating investigators.

Inclusion Criteria


- INCLUSION CRITERIA:

Age 18 years or older.

ECOG performance status less than or equal to 3.

At least one of the following: Exposure risk to HIV, KSHV, or HPV; HIV seropositive; KSHV
seropositive; EBV seropositive; HTLV-1 seropositive; Malignancy, Castleman's disease, or
skin lesions with appearance of Kaposi's sarcoma; Cervical or anal intraepithelial lesion;
Clinical condition reported or hypothesized to be associated with xenotropic murine
leukemia virus-relted virus (XMRV)

Patients not requiring biopsy for a medical indication can be included on the study solely
for the purpose of obtaining research samples, including blood, pleural fluid, peritoneal
fluid, or biopsy samples providing the biopsy or aspiration procedure is of low risk: such
procedure include fine needle aspirates, bone marrow aspirate and biopsy, or excisional
biopsy. Such biopsies can be completely separate from any other protocol or evaluation
process.

EXCLUSION CRITERIA:

Inability to provide informed consent.

Type of Study:

Observational

Study Design:

N/A

Principal Investigator

Robert Yarchoan, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Institute (NCI)

Authority:

United States: Federal Government

Study ID:

010038

NCT ID:

NCT00006518

Start Date:

November 2000

Completion Date:

Related Keywords:

  • HIV Infection
  • Kaposi's Sarcoma
  • HIV
  • KSHV
  • HHV-8
  • Cancer
  • AIDS
  • HIV Infections
  • Acquired Immunodeficiency Syndrome
  • Precancerous Conditions
  • Sarcoma, Kaposi
  • Virus Diseases
  • Sarcoma

Name

Location

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