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临床试验/NCT06147349
NCT06147349招募中不适用

2007 - Rene: Observational Study on the Occurrence of Possible Relapses and on the Quality of Life in Patients Who Underwent Radical Nefrectomy/Tumorectomy Surgery

IRCCS San Raffaele1 个研究点 分布在 1 个国家目标入组 2,500 人开始时间: 2010年1月27日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
2,500
试验地点
1
主要终点
Clinical parameter collection

研究概览

简要总结

The aim of this observational study is to gather pre and post surgery clinical data belonging to patients who underwent radical or partial nephrectomy and to evaluate the impact of the surgery on the quality of life of the patients, as well as possible relapses within a 10 year period.

详细描述

A databasa was created with the intention of collecting data related to patients who underwent radical or partial nefrectomy surgery in an electronic case report form.

Each patient will be followed for 10 years approximately starting from the date of surgery for a total of 2 yearly visits for the first 5 years which could then be diluted in 1 visit per year for the remaining 5 years. At each visit control exams forseen by the standard care for post surgery patients will be evalued and tha data will then be transferred into the database. Yearly, a follow up questionnaire will be sent to the patients' home in order to obtain the information relative to possible relapses. The data collected will be handled following the most strict GCPs and privacy norms. The main objectives of the study are the collection and interpretation of the scientific data with the scope of: obtaining health benefits for the patients involved and for future patients with the same type of cancer, improving the scientific knowledge on the pathology and implementing new strategies for diagnosis and therapy and evaluating the epidemiologic changes of renal neoplasia.

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

入选标准

  • 18 years or older
  • Kidney cancer diagnosis
  • Indication to cancer removal through surgery
  • Ability to read and sign the informed consent

排除标准

  • Age < 18 years
  • Absence of kidney cancer
  • Inability to read and sign the informed consent

结局指标

主要结局

Clinical parameter collection

时间窗: 10 years

Collection intended for the purpose of implementing diagnostic and therepautic strategies for the management of the disease in both the patient enrolled in the study and for future cases.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Francesco Montorsi

Professor

IRCCS San Raffaele

研究点 (1)

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