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

This study is currently recruiting participants.
Verified January 27, 2017 by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
Sponsor:
ClinicalTrials.gov Identifier:
NCT00006518
First Posted: November 23, 2000
Last Update Posted: October 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
November 22, 2000
November 23, 2000
October 19, 2017
November 21, 2000
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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 ]
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Complete list of historical versions of study NCT00006518 on ClinicalTrials.gov Archive Site
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Specimen Collections From Patients With HIV Infection, KSHV Infection, Viral-Related Pre-malignant Lesions and Cancer
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 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.

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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
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  • HIV
  • Kaposi's Sarcoma
  • Lymphomas
  • Multicentric Castleman's Disease
  • Primary Effusion Lymphoma
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
9999
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  • 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.

Sexes Eligible for Study: All
18 Years to 99 Years   (Adult, Senior)
No
Contact: Karen Aleman, R.N. (301) 435-5621 alemank@mail.nih.gov
Contact: Robert Yarchoan, M.D. (240) 760-6075 robert.yarchoan@nih.gov
United States
 
 
NCT00006518
010038
01-C-0038
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National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
National Cancer Institute (NCI)
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Principal Investigator: Robert Yarchoan, M.D. National Cancer Institute (NCI)
National Institutes of Health Clinical Center (CC)
January 27, 2017