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

NCT00006518 | Recruiting

• 2 other identifiers: 01003801-C-0038
• Study Type: observational
• Target: 1,029
• Locations: 1 country
• Sites: 1

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 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.

Conditions

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

Keywords

Tumor; Viruses; HIV; KSHV; AIDS; Natural History

Outcome Measures

Primary Outcomes (1)

• Acquisition of serum, circulating cells, bone marrow, and tumor or normal tissue samples from participants with HIV infection, KSHV infection, or with cancer.

  Proportion of participants that have contributed serum, circulating cells, bone marrow, and tumor or normal tissue samples

  Ongoing

Study Arms (1)

1

Participants with HIV infection, KSHV infection, or with cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Primary Clinical

You may qualify if:

• 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
• 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.

You may not qualify if:

• None

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Publications (5)

• 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.

  PMID: 8652592 BACKGROUND

• 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.

  PMID: 10677347 BACKGROUND

• 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.

  PMID: 10546852 BACKGROUND

• 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.

  PMID: 38941593 DERIVED

• 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.

  PMID: 37740179 DERIVED

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Sarcoma, Kaposi; Lymphoma; Multi-centric Castleman's Disease; Lymphoma, Primary Effusion; Neoplasms; Virus Diseases; Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Infections; Sarcoma; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms, Vascular Tissue; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; HIV Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes

Study Officials

• Robert Yarchoan, M.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anaida Widell

CONTACT

(240) 760-6074; anaida.widell@nih.gov

Robert Yarchoan, M.D.

CONTACT

(240) 760-6075; robert.yarchoan@nih.gov

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2000
• First Posted: November 23, 2000
• Study Start: December 6, 2000
• Last Updated: May 1, 2026

Record last verified: 2026-02-23

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Clinical data available during the study and indefinitely.@@@@@@Genomic data are available once genomic data are uploaded per protocol GDS plan for as long as database is active.
• Access Criteria: Clinical data will be made available via subscription to BTRIS and with the permission of the study PI. @@@@@@Genomic data are made available via dbGaP through requests to the data custodians.

Locations

US (1)