HIV Clinical Trial in Bethesda MD
NCT00006518
| Observational
This study is looking to recruit 999 Participants
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.
...
Details for the study
Population
Primary Clinical
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,
<br /> bone marrow, tumor, or other tissue samples from patients with HIV infection, infection with
<br /> Kaposi s sarcoma associated herpesvirus (KSHV), infection with other oncogenic viruses, or
<br /> cancer. This protocol provides a mechanism to effect a variety of such studies.
<br />
<br /> OBJECTIVES: Acquisition of serum, circulating cells, bone marrow, and tumor or normal tissue
<br /> samples from patients with HIV infection, KSHV infection, or with cancer.
<br />
<br /> ELIGIBILITY: Eligibility criteria include age 18 years or older and at lest one of the
<br /> following: Exposure risk to HIV, KSHV, or HPV; HIV seropositive; KSHV seropositive; EBV
<br /> seropositive; HTLV-1 seropositive; malignancy, Castleman s disease, or skin lesions with
<br /> appearance of Kaposi s sarcoma; or cervical or anal intraepithelial lesion.
<br />
<br /> DESIGN: Blood samples may be collected at the initial visit, and at follow-up visits. Tumor
<br /> samples may be obtained by fine needle aspirate, by removal of pleural or peritoneal fluid,
<br /> by skin punch biopsy, or by excisional biopsy, providing the tumor is accessible with minimal
<br /> risk to the patients. Specific risks will be described in a separate consent to be obtained
<br /> at the time of the biopsy. Samples will be studied in the HIV and AIDS Malignancy Branch,
<br /> CCR, NCI; laboratories in NCI-Frederick; or those of collaborating investigators.
<br />
<br /> ...
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.
Outcome Measures
Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.
Primary
Acquisition of serum, circulating cells, bone marrow, and tumor or normal tissue samples from patients with HIV infection, KSHV infection, or with cancer.
Proportion of patients that have contributed serum, circulating cells, bone marrow, and tumor or normal tissue samples
Study 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.