CARD-IO - CARDiac Toxicity Following ImmunOtherapy Treatment for Melanoma
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Acceptance rate
研究概览
简要总结
People who develop a type of skin cancer known as 'melanoma' are often treated with immunotherapy. The type of immunotherapy used for patients with melanoma is known as Immune Checkpoint Inhibitors (ICI). While ICI is very successful, it can lead to negative side effects that are known as 'immune related adverse events' (irAEs). These irAEs can affect any part of the body and can range in severity from mild symptoms to death.
There has been a lot of research on irAEs that occur during ICI, but less is known about how irAEs can affect people in the long-term.
Although irAEs are common from ICI, acute irAEs affecting the heart (cardiac irAEs) are uncommon. However, as they relate to the heart, they are often serious and have a higher rate of death compared to other types of irAEs. Little is known regarding the long-term effects of ICI on the heart. However, there is some evidence to suggest that ICI may also cause long-term cardiac irAEs such as accelerating a build-up of fatty materials in the arteries known as 'atherosclerosis' and inflammation of plaque in the heart. This can lead to an increased risk of heart attack.
Although there are guidelines for patients on ICI treatment to receive investigations to look for irAEs, including cardiac irAEs, there are no guidelines for monitoring long-term survivors.
The aim of the CARD-IO study is to establish if it is possible to investigate in long-term follow-up cardiac side-effects in patients who received ICI for melanoma. The data for this study would be used to support a larger study in the same patient population. Potentially, this could lead to a change in guidelines and long-term follow-up care for melanoma patients who have received ICI.
详细描述
Primary aim • To establish the feasibility of conducting a study to investigate late cardiac side effects caused by immunotherapy in patients with melanoma in order to generate data to support a larger study in this patient population.
Secondary aims
- To assess factors impacting on the acceptance and adherence with cardiac investigations.
- To contribute to the understanding of long-term cardiac toxicities following immunotherapy which will enable their early recognition.
Primary endpoint
• Acceptance rate (reported as the total number of patients consented divided by the number of patients invited for the study).
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
- •Written informed consent
- •Age 18 years or older
- •Confirmed diagnosis of melanoma
- •Stage IIB or IIC or stage III or stage IV melanoma
- •Previous immunotherapy with immune-checkpoint inhibitors (anti PD-(L)1 +/- anti CTLA-4) for melanoma
- •On standard of care surveillance, at 2 to 10+ years following the completion of immunotherapy treatment
排除标准
- •Medical or psychological condition that would preclude informed consent.
- •Known contraindications to MRI, such as claustrophobia, pregnancy, or indwelling metallic implant which is not MR conditional
- •Current active treatment with systemic therapy for any malignancy.
- •Active treatment with systemic therapy for any malignancy started after the completion of immunotherapy for melanoma.
- •Subjects unable to comply with the study or sample schedule.
- •Planned participation in a drug trial receiving investigational agents.
结局指标
主要结局
Acceptance rate
时间窗: 12 months
total number of patients consented divided by the number of patients invited for the study
次要结局
- Adherence rate(12 months)
- Recruitment rate(12 months)
- Reasons for non-adherence or declining to consent(12 months)
- Difference in adherence rates(12 months)
- Proportion of patients who experience cardiovascular irAEs(12 months)
- Prevalence of cardiac irAEs(12 months)