Specimen Collections From Patients With HIV Infection, KSHV Infection, Viral-Related Pre-malignant Lesions and Cancer
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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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 affect 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:
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 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 Design
Arms and Interventions
Arm | Intervention/Treatment |
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1 Patients with HIV infection, KSHV infection, or with cancer |
Outcome Measures
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. [Ongoing]
Proportion of patients that have contributed serum, circulating cells, bone marrow, and tumor or normal tissue samples
Eligibility Criteria
Criteria
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INCLUSION CRITERIA:
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Age 18 years or older.
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ECOG performance status less than or equal to 3.
At least one of the following:
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Exposure risk to HIV, KSHV, or HPV
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HIV seropositive
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KSHV seropositive
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EBV seropositiv
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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.
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Malignancy, Castleman's disease, or skin lesions with appearance of Kaposi's sarcoma
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Cervical or anal intraepithelial lesion
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Ability of subject to understand and the willingness to sign a written informed consent document. Participants could have a witness signature if they are either blind or illiterate, etc.
EXCLUSION CRITERIA:
Inability to provide informed consent.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland | United States | 20892 |
Sponsors and Collaborators
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Robert Yarchoan, M.D., National Cancer Institute (NCI)
Study Documents (Full-Text)
None provided.More Information
Additional Information:
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.
- 010038
- 01-C-0038
- NCT00898651