Bethesda, Maryland 20892

  • Primary Effusion Lymphoma

Purpose:

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 lest 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.


Study 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 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.


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 seropositiv - HTLV-1 seropositive NOTE: infection with HIV, KSHV, EBV, and HTLV-1 are life-long, so if patients have previously been seropositive or have had a disease associated with KSHV (KS, primary effusion lymphoma [PEL], or KSHV-multicentric Castleman s disease), this is sufficient to meet this criterion for eligibility. - Malignancy, Castleman's disease, or skin lesions with appearance of Kaposi's sarcoma - Cervical or anal intraepithelial lesion EXCLUSION CRITERIA: Inability to provide informed consent.


NCT ID:

NCT00006518


Primary Contact:

Principal Investigator
Robert Yarchoan, M.D.
National Cancer Institute (NCI)

Anaida Widell
Phone: (301) 451-3694
Email: awidell@cc.nih.gov


Backup Contact:

Email: robert.yarchoan@nih.gov
Robert Yarchoan, M.D.
Phone: (240) 760-6075


Location Contact:

Bethesda, Maryland 20892
United States

For more information at the NIH Clinical Center contact National Cancer Institute Referral Office
Phone: (888) NCI-1937

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: June 18, 2021

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