Specimen Collections From Participants With HIV Infection, KSHV Infection, Viral-Related Pre-malignant Lesions and Cancer

National Cancer Institute (NCI)

Status: Enrolling

Conditions: Lymphomas; Kaposi's Sarcoma; HIV; Primary Effusion Lymphoma; Multicentric Castleman's Disease

Study type: Observational

Funder types: NIH

Identifiers

NCT00006518

010038

01-C-0038

Details and patient eligibility

About

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.

Full description

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 (KS); or cervical or anal intraepithelial lesion.

DESIGN:

• Up to 999 participants will be provide samples 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.

Enrollment: 1,029 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

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.

EXCLUSION CRITERIA:

None

Trial design

1,029 participants in 1 patient group

1

Description:

Participants with HIV infection, KSHV infection, or with cancer