Protocol Active Surveillance Small Renal Masses (SRMs)
Ključne besede
Povzetek
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
Intervencija / zdravljenje
Other: Patients with small renal masses
Faza
Skupine rok
Roka | Intervencija / 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 študija | All |
Sprejema zdrave prostovoljce | Da |
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]
2. Evaluate the proportion of patients who do not undergone active treatment [10 years]
Ukrepi sekundarnega rezultata
1. Incidence and nature of disease progression during the period active surveillance [10 years]
2. Evaluation of disease progression [10 years]