Lymphoid Malignancies and Precursors: Tissue Acquisition Protocol
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,295
- 试验地点
- 2
- 主要终点
- sample acquisition
研究概览
简要总结
Background:
- Lab studies help researchers better understand cancer biology. This information may lead to new methods for diagnosing or treating cancer. To develop these studies, researchers want to collect samples from people with cancer or precancer conditions of the lymph system. These conditions include multiple myeloma, different types of lymphoma, and adult leukemia/lymphoma. The samples collected will include blood, urine, bone marrow, and tumor and skin tissue.
Objectives:
- To collect tissue samples to study different types of lymph cancer.
Eligibility:
- Individuals at least 18 years of age who have a lymphoid cancer or precancer condition.
Design:
- Participants will be screened with a physical exam and medical history.
- Different samples will be collected for study. Blood samples will be collected at the initial testing. More blood samples will be collected at different treatment points. Other liquid samples include urine, bone marrow, and any abnormal fluid. Tumor tissue and skin tissue biopsies will also be collected for study.
- Treatment will not be provided as part of this study.
详细描述
Background:
-An estimated 79,190 people living in the United States will be diagnosed with lymphoma in 2012, including 9,060 cases of HL, 70,130 cases of non-Hodgkin's lymphoma (NHL) and multiple cases of adult T-cell leukemia/lymphoma. Laboratory investigations conducted in the Lymphoid Malignancies Branch, including analysis of cellular, molecular, genetic and genomic biology are attempting to develop new prognostic and diagnostic models, therapeutic agents and novel treatment approaches for lymphoid malignancies and pre-malignant conditions.
Objectives:
-This biology protocol is designed to allow sample acquisition for use in the study of lymphoid malignancies and malignancy precursors, including but not limited to B and T cell malignancies, such as diffuse large B-cell lymphoma (DLBCL), Hodgkin s lymphoma (HL), multiple myeloma (MM), lymphomatoid granulomatosis (LYG) and adult T-cell leukemia/lymphoma (ATL) as well as comparison to tissues from patients without lymphoid disease. A variety of laboratory investigations will be conducted on blood, tumor, bone marrow, urine, abnormal fluid and normal tissue, including analysis of cellular, molecular, genetic and genomic biology in the support of NIH translational trials to develop new therapeutic agents and novel treatment approaches as well as new prognostic and diagnostic models.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •LYMPHOID MALIGNANCIES/DISEASES: The following criteria apply only to patients with a known lymphoid malignancy or precursor
- •disease, as described:
- •INCLUSION CRITERIA:
- •Patients with a known lymphoid malignancy or precursor disease to a lymphoid malignancy, including multiple myeloma, B-cell and T-cell lymphomas: including but not limited to diffuse large B-cell lymphoma (DLBCL), Hodgkin s lymphoma (HL), multiple myeloma (MM), lymphomatoid granulomatosis (LYG) and adult T-cell leukemia/lymphoma (ATL).
- •Confirmation of pathological diagnosis is required from the Laboratory of Pathology, NCI. Tumor tissue that has been previously collected and is available for study or that can be collected with minimal additional risk to the subject during sampling required for routine patient care or required testing on an NIH research protocol will be used for diagnosis.
- •Age >= 18 years of age
- •Ability of patient or Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent document NOTE: Patients enrolling with a LAR must be co-enrolled on another study.
排除标准
- •Pregnant individuals will not be eligible.
- •Active symptomatic major organ disorder that would increase the risk of biopsy, including but not limited to ischemic heart disease, recent myocardial infarction, active congestive heart failure, and/or pulmonary dysfunction.
- •Active concomitant medical or psychological illnesses that may increase the risk to the subject or inability to obtain informed consent, at the discretion of the principal investigator.
- •NON-LYMPHOID MALIGNANCIES/DISEASES: The following criteria apply only to patients without a known lymphoid malignancy or precursor disease, as described:
- •INCLUSION CRITERIA:
- •Patients without a known lymphoid malignancy or lymphoid precursor diagnosis who have a planned surgical procedure during which blood or normal lymph node(s)/tissue (i.e., those not with pre-determined likelihood of abnormality/ malignancy) may be obtained for research studies as part of this protocol.
- •Patient is appropriate to undergo the surgical procedure planned, and consented for the same, as needed. NOTE: This study will not evaluate eligibility of the patient for surgery.
- •Age >= 18 years of age
- •Must be able and willing to sign informed consent
- •EXCLUSION CRITERIA:
- •Pregnant individuals will not be eligible.
- •Other active malignancy. NOTE: Patients with a history of curatively treated basal or squamous cell carcinoma or stage 1 melanoma of the skin as well as any in situ carcinoma are eligible. Patients with a malignancy that has been treated with curative intent and who are without evidence of disease for >=2 years will also be eligible at the discretion of the investigator.
- •Active concomitant medical or psychological illnesses that may increase the risk to the subject or inability to obtain informed consent, at the discretion of the principal investigator.
研究组 & 干预措施
2
Patients without a known lymphoid malignancy or precursor disease to a lymphoid malignancy
1
Patients with a known lymphoid malignancy or precursor disease to a lymphoid malignancy
结局指标
主要结局
sample acquisition
时间窗: ongoing
Standard exploratory and descriptive statistical methods will be used, as appropriate to the specific biologic assay. Any findings will be reported in the context of this exploratory study, with appropriate caveats.
次要结局
- Obtain specimens for genetic analysis, establishment of cell lines, and genomic sequence characterizations(baseline and other timepoints TBD by PI/)
- Obtain normal tissues for the comparative analysis of functional and/or structural genomics(baseline)
- Develop new therapeutic targets using molecular profiling(after baseline, through end of study)
- Establish a comprehensive databank of genomic sequence from patients with Burkitt Lymphoma (BL)(baseline through end of study)
- Assess the use of molecular profiling for pathological diagnosis and response correlation(baseline through end of study)