Biospecimen Procurement for Center for Immuno-Oncology Immunotherapy Protocols
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Sample Acquisition
研究概览
简要总结
Background:
Cancer has a major impact in the United States and across the world. In 2015, over 1.5 million new cases of cancer were diagnosed in the U.S. Researchers want to study samples from people with cancer or a pre-malignant condition. They hope to develop more effective treatments.
Objective:
To better understand the biology of malignancies and why certain cancers respond differently to treatment.
Eligibility:
Adults at least 18 years old with cancer or a pre-cancerous condition.
Design:
Participants will be screened with a medical history, physical exam, and blood tests. Their diagnosis will be confirmed by the NCI Laboratory of Pathology.
Participants will send tissue blocks or slides from their original tumor biopsy.
At least once, participants will have a medical history, physical exam, and blood and urine tests.
Participants may have the following tests. They may have them more than once:
Apheresis. A needle in one arm removes blood. Blood is run through a machine and the sample cells are taken out. The rest of the blood is returned by a needle in the other arm.
Bone marrow aspiration and biopsy. The hipbone will be numbed. A needle will be put into the hipbone. Bone marrow will be taken out through the needle.
Piece of cancer tissue taken by a needle and syringe.
Computed tomography (CT) scan, magnetic resonance imaging (MRI) and/or positron emission tomography (PET) scan or ultrasound to help locate their tumor. For the scans, they lie in a machine that takes pictures.
A small piece of skin removed.
Participants will be contacted by phone once a year to find out how they are doing.
详细描述
Background:
-Immunotherapy is a promising approach to the treatment of cancer. CIO investigators are studying immunotherapy for the treatment of diverse malignant and premalignant conditions. These studies require the collection of biospecimens for research purposes.
Objectives:
- To collect and bank blood, apheresis products, tumor, body fluids, and other biospecimens from patients with cancer or a premalignant disease or at risk of cancer from an immunodeficiency.
- To collect and bank biospecimens as directed by companion CIO immunotherapy clinical trial protocols.
- To conduct nucleic acid, protein, and immunological and biological research studies on samples collected.
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:
- •Diagnosis of cancer, a premalignant/neoplastic condition or disease (such as an immunodeficiency) that increases the risk of being diagnosed with a cancer or premalignant/neoplastic condition
- •Age >=18 years of age
- •ECOG performance status of 0-
- •5. Ability and willingness of subject to provide informed consent
- •Additional inclusion criteria pertinent only for participants undergoing apheresis
- •Hemoglobin >= 8 mg/dL and platelet count > 75 K/microL
- •Weight >= 48 kg
- •Central line in place or adequate venous access
排除标准
- •Active concomitant medical or psychological illnesses that may increase the risk to the subject.
- •Inability to provide informed consent
- •Pregnant or breastfeeding women
研究组 & 干预措施
1/Cohort 1
Patients with cancer or a premalignant condition or at risk of cancer from an immunodeficiency
结局指标
主要结局
Sample Acquisition
时间窗: Ongoing
Biospecimen collection for study and understanding of disease.
次要结局
- Associations between clinical parameters, biospecimen characteristics and patient demographics(Ongoing)