Observational Study on the Quality of Life and Functional/Oncological Outcome of Patients Undergoing Surgery for Testicular Removal and/or Removal of Retro-peritoneal Lymph Nodes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- Clinical data
研究概览
简要总结
The research aims to collect data in order to report the main problems related to the testicular cancer; To reach this aim, this study proposes to create a database of the testicular cancer condition.
From this perspective, the aim of this project is the improving of scientific knowledge of the disease and develop appropriate and effective procedures for the diagnosis and treatment of the patient.
详细描述
Testicular cancer constitutes 1% to 1.5% of male tumors, 5% of urological tumors. In the Western society to which we belong, the incidence is between 3 and 6 new cases per 100,000 inhabitants per year. In particular, this incidence has recorded continuous growth over the last thirty years. Different histologies of this disease are known, with a clear prevalence of germ cell tumors (90-95%).
From these general epidemiological coordinates it can be deduced that this pathology could affects a young segment of the population; It must be underlined that a pathology is peculiar due to the impact it has on the affected individual, who must be treated not only from an oncological point of view but also with regards to the sexual, reproductive and psychological-relational aspects. Such complexity requires a systematic and detailed approach to examine all aspects.
The creation of this database let to have a follow up above all an extension over time that is not present in the literature, especially towards the functional aspects of this condition.
The database will represent a resource for future research.
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
- Male
- 接受健康志愿者
- 否
入选标准
- •subjects suffering from suspected neoplastic testicular pathology candidates for testicle removal surgery
- •patients suffering from neoplastic testicular pathology requiring removal of the retroperitoneal lymph nodes
- •subjects > 18 years old
- •subjects with at least elementary education
- •signature of informed consent
排除标准
- •subjects < 18 years
- •presence of mental or physical disability that may prevent the patient from satisfying the requirements of the protocol
结局指标
主要结局
Clinical data
时间窗: Baseline
Collection of clinical data
Testicular objective examination
时间窗: Baseline
Number and size (via Prader orchidometer) of the testicles
Adjuvant therapy
时间窗: Baseline
Which type of adjuvant therapy carried out (chemotherapy - radiotherapy - retroperitoneal lymphadenectomy)
lactate dehydrogenase
时间窗: Follow up after 6 months from baseline
Oncological follow-up through enzymatic value
Testicular objective examination - nodules
时间窗: Baseline
Evaluation presence of nodules
Testicular objective examination - hydrocele
时间窗: Baseline
Evaluation presence of hydrocele
α-feto protein
时间窗: Follow up after 6 months from baseline
Oncological follow-up through enzymatic value
Testicular objective examination - cysts
时间窗: Baseline
Evaluation presence of cysts
Testicular objective examination - varicocele
时间窗: Baseline
Evaluation presence of varicocele
β human Chorionic Gonadotropin
时间窗: Follow up after 6 months from baseline
Oncological follow-up through hormonal value
carcinoembryonic antigen
时间窗: Follow up after 6 months from baseline
Oncological follow-up through hormonal value
次要结局
未报告次要终点
研究者
Andrea Salonia
Professor
IRCCS San Raffaele