Collection of Blood, Bone Marrow, Tumor, or Tissue Samples From Patients With HIV Infection, KSHV Infection, Viral-Related Pre-Malignant Lesions, and/or Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,029
- 试验地点
- 1
- 主要终点
- Acquisition of serum, circulating cells, bone marrow, and tumor or normal tissue samples from participants with HIV infection, KSHV infection, or with cancer.
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- 未提供
研究组 & 干预措施
1
Participants with HIV infection, KSHV infection, or with cancer
结局指标
主要结局
Acquisition of serum, circulating cells, bone marrow, and tumor or normal tissue samples from participants with HIV infection, KSHV infection, or with cancer.
时间窗: Ongoing
Proportion of participants that have contributed serum, circulating cells, bone marrow, and tumor or normal tissue samples
次要结局
未报告次要终点