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

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ClinicalTrials.gov Identifier: NCT00006518
Recruitment Status : Recruiting
First Posted : November 23, 2000
Last Update Posted : March 27, 2023
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

Study Description
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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.

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

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
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Study Type : Observational
Estimated Enrollment : 999 participants
Observational Model: Cohort
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
Actual Study Start Date : December 6, 2000

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Groups and Cohorts
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Group/Cohort
1
Patients with HIV infection, KSHV infection, or with cancer


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
    Proportion of patients that have contributed serum, circulating cells, bone marrow, and tumor or normal tissue samples


Eligibility Criteria
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Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Primary Clinical
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 seropositiv
  • 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.

  • Malignancy, Castleman's disease, or skin lesions with appearance of Kaposi's sarcoma
  • Cervical or anal intraepithelial lesion
  • 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006518


Contacts
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Contact: Anaida Widell (240) 760-6074 anaida.widell@nih.gov
Contact: Robert Yarchoan, M.D. (240) 760-6075 robert.yarchoan@nih.gov

Locations
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United States, Maryland
National Institutes of Health Clinical Center Recruiting
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Robert Yarchoan, M.D. National Cancer Institute (NCI)
More Information
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Additional Information:

Publications:

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Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00006518    
Obsolete Identifiers: NCT00898651
Other Study ID Numbers: 010038
01-C-0038
First Posted: November 23, 2000    Key Record Dates
Last Update Posted: March 27, 2023
Last Verified: January 19, 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: .All IPD recorded in the medical record will be shared with intramural investigators upon request. @@@@@@In addition, all large scale genomic sequencing data will be shared with subscribers to dbGaP
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):
Tumor
Viruses
HIV
 KSHV
AIDS
Natural History
Additional relevant MeSH terms:
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Infections
HIV Infections
Sarcoma, Kaposi
Virus Diseases
Lymphoma
Lymphoma, Primary Effusion
Castleman Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Sarcoma
 Neoplasms, Connective and Soft Tissue
Blood-Borne Infections
Communicable Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Immunologic Deficiency Syndromes
Herpesviridae Infections
DNA Virus Infections
Neoplasms, Vascular Tissue
Lymphoma, B-Cell
Lymphoma, Non-Hodgkin