Clinical Trial: Specimen Collections From Patients With HIV Infection, KSHV Infection, Viral-Related Pre-malignant Lesions and Cancer

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

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

Brief 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 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.


Detailed 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.
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    Sponsor: National Cancer Institute (NCI)

    Current Primary Outcome: Acquisition of serum, circulating cells, bone marrow, and tumor or normal tissue samples from patients with HIV infection, KSHV infection, or with cancer. [ Time Frame: Ongoing ]

    Original Primary Outcome:

    Current Secondary Outcome:

    Original Secondary Outcome:

    Information By: National Institutes of Health Clinical Center (CC)

    Dates:
    Date Received: November 22, 2000
    Date Started: November 17, 2000
    Date Completion:
    Last Updated: April 21, 2017
    Last Verified: January 27, 2017