Specimen Collections From Participants With HIV Infection, KSHV Infection, Viral-Related Pre-mali… (NCT00006518) | Clinical Trial Compass
RecruitingNot Applicable
Specimen Collections From Participants With HIV Infection, KSHV Infection, Viral-Related Pre-malignant Lesions and Cancer
United States1,029 participantsStarted 2000-12-06
Plain-language 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 affect a variety of such studies.
OBJECTIVES:
-Acquisition of serum, circulating cells, bone marrow, and tumor or normal tissue samples from participants 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:
* 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 participants.
* 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* 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
NOTE: infection with HIV, KSHV, EBV, and HTLV-1 are life-long, so if participants have previously been seropositive or have had a disease associated with KSHV (KS, primary effusion lymphoma \[PEL\], or KSHV-multicentric Castleman s disease \[MCD\]), this is sufficient to meet this criterion for eligibility.
* Malignancy, MCD, or skin lesions with appearance of KS
* Cervical or anal intraepithelial lesion
* Ability of participant to understand and the willingness to sign a written informed consent document.
EXCLUSION CRITERIA:
None
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial is focused on collecting biological samples like blood, bone marrow, and tumor tissue rather than testing a new treatment, what would actually happen to me during participation — and would it affect my current care for HIV, Kaposi's Sarcoma, or any other condition I have?
2The trial involves collecting bone marrow and tumor tissue samples, which can be more invasive — how would my doctor decide which types of samples I'd be asked to provide, and what are the specific risks associated with those procedures?
3Given that this is a specimen collection study and not a treatment trial, should I be pursuing active treatment for my condition separately, and would participating here in any way delay or interfere with getting standard care?
4Since the study is recruiting people with a range of conditions including KSHV infection, Kaposi's Sarcoma, lymphomas, and Multicentric Castleman's Disease, can my doctor help me understand what researchers are hoping to learn from these samples and how that research might eventually benefit people with my specific diagnosis?
5Are there any privacy or consent considerations I should understand about how my tissue and blood samples will be stored and used in future research, and can I withdraw my samples from the study if I change my mind later?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Acquisition of serum, circulating cells, bone marrow, and tumor or normal tissue samples from participants with HIV infection, KSHV infection, or with cancer.