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

Brief Title

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

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

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.

      ...
    

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:

      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.
    


Study Type

Observational


Primary Outcome

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


Condition

HIV


Study Arms / Comparison Groups

 1
Description:  Patients with HIV infection, KSHV infection, or with cancer

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

9999

Start Date

December 6, 2000



Eligibility 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

        EXCLUSION CRITERIA:

        Inability to provide informed consent.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Robert Yarchoan, M.D., (240) 760-6074, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00006518

Organization ID

010038

Secondary IDs

01-C-0038

Responsible Party

Sponsor

Study Sponsor

National Cancer Institute (NCI)


Study Sponsor

Robert Yarchoan, M.D., Principal Investigator, National Cancer Institute (NCI)


Verification Date

August 31, 2021