Slovenian
Albanian
Arabic
Armenian
Azerbaijani
Belarusian
Bengali
Bosnian
Catalan
Czech
Danish
Deutsch
Dutch
English
Estonian
Finnish
Français
Greek
Haitian Creole
Hebrew
Hindi
Hungarian
Icelandic
Indonesian
Irish
Italian
Japanese
Korean
Latvian
Lithuanian
Macedonian
Mongolian
Norwegian
Persian
Polish
Portuguese
Romanian
Russian
Serbian
Slovak
Slovenian
Spanish
Swahili
Swedish
Turkish
Ukrainian
Vietnamese
Български
中文(简体)
中文(繁體)

Protocol Active Surveillance Small Renal Masses (SRMs)

Samo registrirani uporabniki lahko prevajajo članke
Prijava / prijava
Povezava se shrani v odložišče
StanjeNabor
Sponzorji
IRCCS San Raffaele

Ključne besede

Povzetek

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.

Datumi

Nazadnje preverjeno: 01/31/2020
Prvič predloženo: 01/10/2019
Predviden vpis oddan: 01/10/2019
Prvič objavljeno: 01/14/2019
Zadnja posodobitev oddana: 02/09/2020
Zadnja posodobitev objavljena: 02/10/2020
Dejanski datum začetka študija: 04/28/2015
Predvideni datum primarnega zaključka: 12/10/2023
Predvideni datum zaključka študije: 12/10/2028

Stanje ali bolezen

Kidney Cancer

Intervencija / zdravljenje

Other: Patients with small renal masses

Faza

-

Skupine rok

RokaIntervencija / zdravljenje
Other: Patients with small renal masses
Active surveillance
Other: Patients with small renal masses

Merila upravičenosti

Starost, primerna za študij 50 Years Za 50 Years
Spol, upravičen do študijaAll
Sprejema zdrave prostovoljceDa
Merila

Inclusion Criteria:

1. ability to read, understand and interpret an informed consent;

2. voluntary subscription of the active surveillance protocol through written informed consent; 3) age over 50 years;

4) diagnosis of monolateral, monofocal, and first-rate solid renal mass less than 2 cm; 5) absence of symptoms due to renal tumor pathology.

Exclusion Criteria:

1. patients with a history of previous renal neoplasia;

2. monorenal patients;

3. patients with hereditary renal tumors (such as tuberous sclerosis and Von Hippel Lindau syndrome, etc.);

4. patients with metastasis;

5. patients suffering from immunodepressive diseases;

6. patients on concomitant therapy with chemotherapeutic agents or systemic immunosuppressants;

7. patients with life expectancy of less than 1 year.

Izid

Primarni izidni ukrepi

1. Evaluate the therapeutic efficacy of active surveillance for small renal masses [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.

2. Evaluate the proportion of patients who do not undergone active treatment [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

Ukrepi sekundarnega rezultata

1. Incidence and nature of disease progression during the period active surveillance [10 years]

Determine the incidence and nature of disease progression during the period of active surveillance; determine the annual growth rate of SRMs equal to or less than 2 cm of diameter; evaluate the appearance of symptoms associated with the disease (pain, haematuria) or syndrome paraneoplasty (fever, cachexia, hypercalcemia, polycythemia, granulocytosis); establish possible factors clinical, pathological and biological predictive of local or metastatic disease progression or that require surgery.

2. Evaluation of disease progression [10 years]

The disease progression is defined as the growth of the maximum diameter of the renal mass equal to or more than 4 cm or doubling the tumor volume over a period of time ≤ 12 months. It is considered sign of progression also the vascular invasion, with the appearance of thrombosis of the renal vein or of the inferior vena cava;

Pridružite se naši
facebook strani

Najbolj popolna baza zdravilnih zelišč, podprta z znanostjo

  • Deluje v 55 jezikih
  • Zeliščna zdravila, podprta z znanostjo
  • Prepoznavanje zelišč po sliki
  • Interaktivni GPS zemljevid - označite zelišča na lokaciji (kmalu)
  • Preberite znanstvene publikacije, povezane z vašim iskanjem
  • Iščite zdravilna zelišča po njihovih učinkih
  • Organizirajte svoje interese in bodite na tekočem z raziskavami novic, kliničnimi preskušanji in patenti

Vnesite simptom ali bolezen in preberite o zeliščih, ki bi lahko pomagala, vnesite zelišče in si oglejte bolezni in simptome, proti katerim se uporablja.
* Vse informacije temeljijo na objavljenih znanstvenih raziskavah

Google Play badgeApp Store badge