Senescence and the Early Ageing Phenotype After Chemotherapy for Testicular Cancer: the SEA-CAT Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 192
- 试验地点
- 1
- 主要终点
- Cellular senescence
研究概览
简要总结
Cisplatin-combination chemotherapy causes inevitably DNA damage by platinum-DNA adduct formation of both tumor cells but also healthy cells. It therefore stands to reason that testicular cancer treatment causes an increased burden of senescent cells, which causes upregulation of the SASP resulting in a pro-inflammatory phenotype. The investigators hypothesize that this may be an important mechanism behind development of late effects and an early ageing phenotype after treatment for testicular cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •In order to be eligible to participate in the cross-sectional part of this study, a subject must meet all of the following criteria:
- •Diagnosed with metastatic testicular cancer in 1999-2012 (stage II or higher)
- •Received first-line cisplatin-based chemotherapy
- •Was younger than 50 years of age at start of chemotherapy
- •In order to be eligible to participate in the longitudinal part of this study, a subject must meet all of the following criteria:
- •Chemotherapy-group:
- •Diagnosis of metastatic testicular cancer (stage II or higher)
- •Is about to start with first-line cisplatin-based chemotherapy
- •Younger than 50 years of age at diagnosis of metastatic testicular cancer
- •Stage I control-group:
- •Diagnosis of testicular cancer stage I disease
- •Younger than 50 years of age at diagnosis of testicular cancer
排除标准
- •A potential subject who meets any of the following criteria will be excluded from participation in this study:
- •- Not able to provide informed consent (in example in case of mental or psychiatric disability)
研究组 & 干预措施
Cross-sectional study:
Testicular cancer survivors who were treated between 2000 and 2005 or between 2006 and 2012 with cisplatin-combination chemotherapy and who were extensively phenotypically mapped within two longitudinal trials (15,16) will be invited to participate in a single cross-sectional follow-up study visit 5-20 years after chemotherapy.
干预措施: Skin biopsy (Diagnostic Test)
Cross-sectional study:
Testicular cancer survivors who were treated between 2000 and 2005 or between 2006 and 2012 with cisplatin-combination chemotherapy and who were extensively phenotypically mapped within two longitudinal trials (15,16) will be invited to participate in a single cross-sectional follow-up study visit 5-20 years after chemotherapy.
干预措施: Subcutaneous fat biopsy (Diagnostic Test)
Longitudinal study - chemotherapy group
Patients with metastasized testicular cancer who are about to start with cisplatin-combination chemotherapy will be invited in the longitudinal part of this study. Study participation involves four study visits:
Visit 1: before start of chemotherapy Visit 2:before third cycle of chemotherapy Visit 3: one month after completion of chemotherapy Visit 4: one year after start of chemotherapy
干预措施: Skin biopsy (Diagnostic Test)
Longitudinal study - chemotherapy group
Patients with metastasized testicular cancer who are about to start with cisplatin-combination chemotherapy will be invited in the longitudinal part of this study. Study participation involves four study visits:
Visit 1: before start of chemotherapy Visit 2:before third cycle of chemotherapy Visit 3: one month after completion of chemotherapy Visit 4: one year after start of chemotherapy
干预措施: Subcutaneous fat biopsy (Diagnostic Test)
Longitudinal study - stage I control group
Patients with stage I testicular cancer will serve as control group with three study visits:
Visit 1: at time of orchidectomy Visit 2: one month Visit 3: one year after orchidectomy
干预措施: Skin biopsy (Diagnostic Test)
Longitudinal study - stage I control group
Patients with stage I testicular cancer will serve as control group with three study visits:
Visit 1: at time of orchidectomy Visit 2: one month Visit 3: one year after orchidectomy
干预措施: Subcutaneous fat biopsy (Diagnostic Test)
结局指标
主要结局
Cellular senescence
时间窗: 1 year
The change in the amount of senescent cells in skin and fat tissue (defined as % of cells in which nucleus is stained positive for P16, P21 and yH2Ax)
次要结局
- Senescence-associated secretory phenotype (SASP)(1 year)
- Pulse-wave velocity(1 year)
- Adipocytokines 2(1 year)
- Platinum levels(1 year)
- Adipocytokines 1(1 year)