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

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

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 affect a variety of such studies. OBJECTIVES: -Acquisition of serum, circulating cells, bone marrow, and tumor or normal tissue samples from participants 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: * Up to 999 subjects will be enrolled in this study. * Blood samples may be collected at the initial visit, and at follow-up visits. * Other fluids/excretions may be collected (such as urine, saliva, semen, and stool). * 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 participants. * 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

⁃ NOTE: infection with HIV, KSHV, EBV, and HTLV-1 are life-long, so if participants have previously been seropositive or have had a disease associated with KSHV (KS, primary effusion lymphoma \[PEL\], or KSHV-multicentric Castleman s disease \[MCD\]), this is sufficient to meet this criterion for eligibility.

• Malignancy, MCD, or skin lesions with appearance of KS

• Cervical or anal intraepithelial lesion

• Ability of participant to understand and the willingness to sign a written informed consent document.

Locations
United States
Maryland
National Institutes of Health Clinical Center
RECRUITING
Bethesda
Contact Information
Primary
Anaida Widell
anaida.widell@nih.gov
(240) 760-6074
Backup
Robert Yarchoan, M.D.
robert.yarchoan@nih.gov
(240) 760-6075
Time Frame
Start Date: 2000-12-06
Participants
Target number of participants: 1029
Treatments
1
Participants with HIV infection, KSHV infection, or with cancer
Sponsors
Leads: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov

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