Long-Term Follow-Up Study of Recipients of Gene Transfer Research Protocols
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Document Long-Term Safety of Gene-Transfer Research
研究概览
简要总结
The goal of this clinical research study is to collect information about the long-term safety of gene transfer therapy. This study is also designed to create a database of medical information about patients who have received gene transfer therapy, in order for researchers to track and review the long-term safety and any effects (good or bad) of gene transfer therapy.
详细描述
Study Procedures for Years 1-5:
If you agree to take part in this study, you will come to the clinic for study visits once a year during Years 1-5. It is your choice whether to visit your regular local doctor or your study doctor at MD Anderson. (If you visit your regular local doctor, you will need to have your test results and blood samples mailed to the study staff.) You will receive a reminder phone call once a year, when it is time to schedule these visits.
At these visits, the following procedures will be performed:
- Blood (about 2-4 tablespoons each time) will be drawn for routine tests.
- You will have a physical exam, including measurement of your vital signs (blood pressure, heart rate, temperature, and breathing rate).
- You will fill out a questionnaire that asks about your medical history (your general health, the status of any medical conditions, and any illnesses or hospitalizations that may have occurred). It should take about 15-30 minutes to complete.
- You will be asked if there have been any changes in your contact information.
- If necessary to check the status of the disease, you will have scans (x-rays and/or computed tomography [CT] scans) and/or additional routine blood tests (about 1-2 tablespoons).
Study Procedures for Years 6-15:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient or patient's legal representative(s) provided written informed consent to participate in a gene transfer study at the University of Texas MD Anderson Cancer Center (MD Anderson).
- •Patient will receive vector or vector-treated cells at MD Anderson.
- •Patient or patient's legal representative(s) is/are able to provide written informed consent to participate in this long-term follow-up protocol for gene transfer participants for up to 15 years following administration of gene therapy product.
- •Agree to allow clinical samples to be collected and stored at MD Anderson and/or at a NIH designated facility such as the NGVB.
排除标准
- •1) Subject's gene transfer protocol is not approved at MD Anderson Cancer Center.
研究组 & 干预措施
Gene Transfer Therapy
Study participants receiving gene therapy product at MD Anderson Cancer Center
干预措施: Questionnaires (Behavioral)
Gene Transfer Therapy
Study participants receiving gene therapy product at MD Anderson Cancer Center
干预措施: Blood Tests (Other)
结局指标
主要结局
Document Long-Term Safety of Gene-Transfer Research
时间窗: 15 years
First 5 years following infusion of vector or vector-treated cells: Participants evaluated on annual basis. Years 6 to 15 following infusion of vector or vector-treated cells: Participants mailed questionnaires. Participants in retroviral studies: Up to 60 mL (max 1 mL/kg) blood will be obtained to check for replication-competent retrovirus (RCR) every 3 months during the first year, and then blood archived annually thereafter. Replication competent vector testing performed when there is a clinical indication or when requested by the FDA.
次要结局
未报告次要终点