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临床试验/NCT03804320
NCT03804320招募中不适用

Sorveglianza Attiva Dei Tumori Renali T1a Uguali o Inferiori a 2 cm

IRCCS San Raffaele2 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2015年4月29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
180
试验地点
2
主要终点
Evaluate the therapeutic efficacy of active surveillance for small renal masses

研究概览

简要总结

Prospective study of active surveillance, non-randomized, multicentric, in asymptomatic patients over the age of 50 years, not affected by other tumors, with occasional diagnosis of single monolateral solid renal mass equal to or less than 2 cm of diameter. Diagnosis will be performed with chest CT abdomen with contrast and / or MRI abdomen with Gadolinium (Gd); during the first year of active surveillance, the patient's status will be evaluated at 3, 6, 9 and 12 months from the diagnosis and, subsequently, according to the schedule of events shown in the table "Event Planning" At the end of the 5 years of follow up, the patient will be entrusted to his / her own treating physician, with indication to perform abdomen and chest x-ray echography every 6 months and thoracic abdomen TAC with contrast and / or MRI abdomen with (Gd) every 2 years up to 10 years from instrumental radiological diagnosis and registration and communication of the possible date of death and cause The primary caregivers and the patient will be contacted annually by the promoter center of the study at the end of the first 5 years of study follow up and the data will be entered in the database by the promoter center. The indication to surgical treatment or ablative treatment will be considered in the following cases: 1. appearance of metastasis 2. increase of the maximum diameter of the renal mass equal to or greater than 4 cm 3. time of doubling of the tumor mass size less than or equal to 12 months 4. appearance of symptoms associated with renal disease (pain, haematuria) 5. appearance of paraneoplastic syndrome (fever, cachexia, hypercalcemia, polycythemia, ranulocytosis) 6. willingness expressed by the patient to undergo surgery or ablative operation In the presence of at least one of the aforementioned criteria, the attending physician can evaluate the possible execution of renal biopsy. The finding of renal biopsy proved negative for neoplasia may allow the continuation of the active surveillance procedure undertaken, independently indi - ding from the presence of one of the above mentioned criteria. If the renal biopsy is negative, the therapeutic decision (continuation of the follow up within the protocol in question, surgery or exit from the protocol) will be agreed between the patient and the patient. In the case of a positive renal biopsy for renal neoplasia, the patient may be a candidate for renal tumorectomy / radical nephrectomy.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ability to read, understand and interpret an informed consent;
  • voluntary subscription of the active surveillance protocol through written informed consent; 3) age over 50 years;
  • diagnosis of monolateral, monofocal, and first-rate solid renal mass less than 2 cm; 5) absence of symptoms due to renal tumor pathology.

排除标准

  • patients with a history of previous renal neoplasia;
  • monorenal patients;
  • patients with hereditary renal tumors (such as tuberous sclerosis and Von Hippel Lindau syndrome, etc.);
  • patients with metastasis;
  • patients suffering from immunodepressive diseases;
  • patients on concomitant therapy with chemotherapeutic agents or systemic immunosuppressants;
  • patients with life expectancy of less than 1 year.

结局指标

主要结局

Evaluate the therapeutic efficacy of active surveillance for small renal masses

时间窗: 10 years

Evaluate the therapeutic efficacy of active surveillance in patients with diagnosis of small renal tumor masses equal to or less than 2 cm in diameter.

Evaluate the proportion of patients who do not undergone active treatment

时间窗: 10 years

Proportion of patients who do not perform tumorectomy , tumor ablation or nephrectomy on the number of eligible patients that have been monitored for 12 months or more or have undergone surgery within 12 months

次要结局

  • Incidence and nature of disease progression during the period active surveillance(10 years)
  • Evaluation of disease progression(10 years)

研究者

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

Roberto Bertini

Principal investigator

IRCCS San Raffaele

研究点 (2)

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