Longitudinal Assessment of Therapy-related Early Ageing in Adolescent and Young Adult (AYA) Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change in senescence marker P16
研究概览
简要总结
Longitudinal cohort study; measurements before start of systemic therapy and one year later.
详细描述
Rationale:
Compared with survivors of childhood cancer, there is sparse knowledge about the long-term morbidity and mortality of adolescent and young adult (AYA) cancer patients, who are diagnosed at age 18-39 and have an 80% chance to survive. Following cancer treatment, many cancer survivors, including those at AYA age, have an increased risk of cardiovascular disease. Early ageing has been described in paediatric and certain adult cancer survivor populations. One of the responsible mechanisms behind biological ageing is cellular senescence, characterized by a stable arrest of the cell cycle which occurs in response to stress and damage. In all organisms the number of senescent cells increases with age and senescence has been associated with age-related diseases, like atherosclerosis and Alzheimer. Early ageing as a result of intensive cancer treatment with systemic therapy and radiation may result in early cardiovascular disease. However, information about senescence, early vascular ageing and related patient and tumour characteristics is missing for AYAs.
Objective:
to determine markers related to early ageing and senescence in AYA cancer patients before and after systemic therapy, in order to assess treatment-related early vascular ageing and associated tumour and patient characteristics.
Study design:
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 39 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-39 years at cancer diagnosis
- •Having a histologically and/or cytologically confirmed cancer diagnosis, including leukemia, (non-)Hodgkin lymphoma, testicular cancer, osteosarcoma, Ewing sarcoma, breast cancer, and cervical cancer.
- •Scheduled to start systemic therapy with curative intent. Allowed treatments (concurrent or sequential) are: surgery, radiotherapy, chemotherapy, antibodies.
排除标准
- •patients who are not able to understand the patient information letter and informed consent form
- •patients who will be treated with immune checkpoint inhibitors or targeted therapy with inhibitors of angiogenesis
- •patients who have been treated with systemic therapy or radiotherapy for a previous malignancy (exceptions: in situ carcinoma of the cervix or uterus and adequately treated basal and squamous cell carcinoma of the skin).
结局指标
主要结局
Change in senescence marker P16
时间窗: at baseline and 1 year after start systemic therapy
determine change in senescence marker P16 between start of systemic therapy and one year later.
次要结局
- Association between treatment type and change in senescence marker P16(at baseline and 1 year after start systemic therapy)
- Association between age and change in senescence marker P16(at baseline and 1 year after start systemic therapy)
- Prevalence of classical cardiovascular risk factors (smoking, lipids, BMI, glucose)(at baseline and 1 year after start systemic therapy)
- Associations between senescence, inflammation, and cardiovascular risk factors(at baseline and 1 year after start systemic therapy)
- Changes in SASPs and vascular markers(at baseline and 1 year after start systemic therapy)