|
Protocol Number:
01-C-0038
- 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
- Number:
01-C-0038
- 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.
- Sponsoring Institute:
-
National Cancer Institute (NCI)
- Recruitment Detail
- Type:
Participants currently recruited/enrolled
- Gender:
Male & Female
- Referral Letter Required:
No
- Population Exclusion(s):
Children
- 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 seropositive; HTLV-1 seropositive; Malignancy, Castleman's disease, or skin lesions with appearance of Kaposi's sarcoma; or Cervical or anal intraepithelial lesion.
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 sepatate from any other protocol or evaluation process.
EXCLUSION CRITERIA:
Inability to provide informed consent.
- Special Instructions:
Currently Not Provided
- Keywords:
-
HIV
-
KSHV
-
HHV-8
-
Cancer
-
AIDS
- Recruitment Keyword(s):
-
None
- Condition(s):
-
HIV Infection
-
Kaposi's Sarcoma
- Investigational Drug(s):
- None
- Investigational Device(s):
- None
- Intervention(s):
- None
- Supporting Site:
- National Cancer Institute
- Contact(s):
-
NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office Phone: 1-888-NCI-1937 Fax: Not Listed Electronic Address: ncicssc@mail.nih.gov
- Citation(s):
-
Regulatiomn of HIV-1 protease activity through cysteine modification
-
HIV-2 protease is inactiviated after oxidation at the dimer interface and activity can be partly restored with methionine sulphoxide reductase
-
HIV-specific immunity following immunization with HIV synthetic envelope peptides in asymptomatic HIV-infected patients
If you have:
Search The Studies | Help | Questions | Clinical Center Home | NIH Home
National Institutes of Health Clinical Center
Bethesda, Maryland 20892. Last update: 05/05/2009
|
|