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

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.

Condition
HIV Kaposi's Sarcoma Lymphomas Multicentric Castleman's Disease Primary Effusion Lymphoma


Study Type:	Observational
Study Design:	Time Perspective: Prospective
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer HIV/AIDS Lymphoma Soft Tissue Sarcoma

Genetic and Rare Diseases Information Center resources: Angiofollicular Lymph Hyperplasia Angiomatous Lymphoid Hamartoma B-cell Lymphomas Castleman's Disease Classic Kaposi Sarcoma Lymphosarcoma Malignant Mesenchymal Tumor Multicentric Castleman’s Disease Primary Effusion Lymphoma Soft Tissue Sarcoma

U.S. FDA Resources

Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:

Acquisition of serum, circulating cells, bone marrow, and tumor or normal tissue samples from patients with HIV infection, KSHV infection, or with cancer. [ Designated as safety issue: No ]


Estimated Enrollment:	99999999
Study Start Date:	November 2000

Detailed 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 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.

Eligibility


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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; 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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006518

Contacts


Contact: Kathleen Wyvill, R.N.	(301) 435-5622	wyvillk@mail.nih.gov
Contact: Robert Yarchoan, M.D.	(301) 496-0328	robert.yarchoan@nih.gov

Locations


United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike	Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office (888) NCI-1937

Sponsors and Collaborators

National Cancer Institute (NCI)

Investigators


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

More Information

Additional Information:

NIH Clinical Center Detailed Web Page This link exits the ClinicalTrials.gov site

Publications:

Davis DA, Dorsey K, Wingfield PT, Stahl SJ, Kaufman J, Fales HM, Levine RL. Regulation of HIV-1 protease activity through cysteine modification. Biochemistry. 1996 Feb 20;35(7):2482-8.

Davis DA, Newcomb FM, Moskovitz J, Wingfield PT, Stahl SJ, Kaufman J, Fales HM, Levine RL, Yarchoan R. HIV-2 protease is inactivated after oxidation at the dimer interface and activity can be partly restored with methionine sulphoxide reductase. Biochem J. 2000 Mar 1;346 Pt 2:305-11.

Pinto LA, Berzofsky JA, Fowke KR, Little RF, Merced-Galindez F, Humphrey R, Ahlers J, Dunlop N, Cohen RB, Steinberg SM, Nara P, Shearer GM, Yarchoan R. HIV-specific immunity following immunization with HIV synthetic envelope peptides in asymptomatic HIV-infected patients. AIDS. 1999 Oct 22;13(15):2003-12.


Responsible Party:	National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
ClinicalTrials.gov Identifier:	NCT00006518 History of Changes
Obsolete Identifiers:	NCT00898651
Other Study ID Numbers:	010038, 01-C-0038
Study First Received:	November 22, 2000
Last Updated:	January 27, 2015
Health Authority:	United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):


Tumor Viruses HIV KSHV AIDS

Additional relevant MeSH terms:


Lymphoma Lymphoma, Primary Effusion Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases	Lymphoma, B-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on March 01, 2015