Specimen Collections From Participants With HIV Infection, KSHV Infection, Viral-Related Pre-malignant Lesions and Cancer
NCT ID: NCT00006518
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1029 participants
OBSERVATIONAL
2000-12-06
Brief Summary
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* 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 participants 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:
* 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 participants.
* 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 Description
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* 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 participants 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 (KS); or cervical or anal intraepithelial lesion.
DESIGN:
* Up to 999 participants will be provide samples 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 participants.
* 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.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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1
Participants with HIV infection, KSHV infection, or with cancer
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
NOTE: infection with HIV, KSHV, EBV, and HTLV-1 are life-long, so if participants have previously been seropositive or have had a disease associated with KSHV (KS, primary effusion lymphoma \[PEL\], or KSHV-multicentric Castleman s disease \[MCD\]), this is sufficient to meet this criterion for eligibility.
* Malignancy, MCD, or skin lesions with appearance of KS
* Cervical or anal intraepithelial lesion
* Ability of participant to understand and the willingness to sign a written informed consent document.
Exclusion Criteria
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Responsible Party
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Principal Investigators
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Robert Yarchoan, M.D.
Role: PRINCIPAL_INVESTIGATOR
National Cancer Institute (NCI)
Locations
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National Institutes of Health Clinical Center
Bethesda, Maryland, United States
Countries
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Central Contacts
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References
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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. doi: 10.1021/bi951525k.
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(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. doi: 10.1097/00002030-199910220-00002.
Lage SL, Ramaswami R, Rocco JM, Rupert A, Davis DA, Lurain K, Manion M, Whitby D, Yarchoan R, Sereti I. Inflammasome activation in patients with Kaposi sarcoma herpesvirus-associated diseases. Blood. 2024 Oct 3;144(14):1496-1507. doi: 10.1182/blood.2024024144.
Ramaswami R, Tagawa T, Mahesh G, Serquina A, Koparde V, Lurain K, Dremel S, Li X, Mungale A, Beran A, Ohler ZW, Bassel L, Warner A, Mangusan R, Widell A, Ekwede I, Krug LT, Uldrick TS, Yarchoan R, Ziegelbauer JM. Transcriptional landscape of Kaposi sarcoma tumors identifies unique immunologic signatures and key determinants of angiogenesis. J Transl Med. 2023 Sep 22;21(1):653. doi: 10.1186/s12967-023-04517-5.
Related Links
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NIH Clinical Center Detailed Web Page
Other Identifiers
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01-C-0038
Identifier Type: -
Identifier Source: secondary_id
010038
Identifier Type: -
Identifier Source: org_study_id
NCT00898651
Identifier Type: -
Identifier Source: nct_alias