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

This study is currently recruiting participants.
Verified January 27, 2017 by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
Sponsor:
ClinicalTrials.gov Identifier:
NCT00006518
First Posted: November 23, 2000
Last Update Posted: October 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
  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: 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

Resource links provided by NLM:


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

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. [ Time Frame: Ongoing ]

Estimated Enrollment: 9999
Study Start Date: November 21, 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

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.


Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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
Contact: Karen Aleman, R.N. (301) 435-5621 alemank@mail.nih.gov
Contact: Robert Yarchoan, M.D. (240) 760-6075 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:
Publications:
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00006518     History of Changes
Obsolete Identifiers: NCT00898651
Other Study ID Numbers: 010038
01-C-0038
First Submitted: November 22, 2000
First Posted: November 23, 2000
Last Update Posted: October 19, 2017
Last Verified: January 27, 2017

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):
Tumor
Viruses
HIV
KSHV
AIDS

Additional relevant MeSH terms:
Sarcoma, Kaposi
Lymphoma
Infection
HIV Infections
Acquired Immunodeficiency Syndrome
Giant Lymph Node Hyperplasia
Lymphoma, Primary Effusion
Precancerous Conditions
Virus Diseases
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Slow Virus Diseases
Herpesviridae Infections
DNA Virus Infections
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms, Vascular Tissue
Lymphoma, B-Cell
Lymphoma, Non-Hodgkin