Protocol Active Surveillance Small Renal Masses (SRMs)
Study Details
Study Description
Brief Summary
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.
Condition or Disease | Intervention/Treatment | Phase |
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|
N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Other: Patients with small renal masses Active surveillance |
Other: Active Surveillance
|
Outcome Measures
Primary Outcome Measures
- 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.
- 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
Secondary Outcome Measures
- 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.
- 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;
Eligibility Criteria
Criteria
Inclusion Criteria:
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ability to read, understand and interpret an informed consent;
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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.
Exclusion Criteria:
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patients with a history of previous renal neoplasia;
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monorenal patients;
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patients with hereditary renal tumors (such as tuberous sclerosis and Von Hippel Lindau syndrome, etc.);
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patients with metastasis;
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patients suffering from immunodepressive diseases;
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patients on concomitant therapy with chemotherapeutic agents or systemic immunosuppressants;
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patients with life expectancy of less than 1 year.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | IRCCS San Raffaele | Milan | Italy | 20132 |
Sponsors and Collaborators
- IRCCS San Raffaele
Investigators
- Principal Investigator: Roberto Bertini, IRCCS San Raffaele
Study Documents (Full-Text)
None provided.More Information
Publications
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- Jemal A, Bray F, Center MM, Ferlay J, Ward E, Forman D. Global cancer statistics. CA Cancer J Clin. 2011 Mar-Apr;61(2):69-90. doi: 10.3322/caac.20107. Epub 2011 Feb 4. Erratum in: CA Cancer J Clin. 2011 Mar-Apr;61(2):134.
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- Lane BR, Babineau D, Kattan MW, Novick AC, Gill IS, Zhou M, Weight CJ, Campbell SC. A preoperative prognostic nomogram for solid enhancing renal tumors 7 cm or less amenable to partial nephrectomy. J Urol. 2007 Aug;178(2):429-34. Epub 2007 Jun 11.
- Lane BR, Chen H, Morrow M, Anema JG, Kahnoski RJ. Increasing use of kidney sparing approaches for localized renal tumors in a community based health system: impact on renal functional outcomes. J Urol. 2011 Oct;186(4):1229-35. doi: 10.1016/j.juro.2011.05.081. Epub 2011 Aug 17.
- Mason RJ, Abdolell M, Trottier G, Pringle C, Lawen JG, Bell DG, Jewett MA, Klotz L, Rendon RA. Growth kinetics of renal masses: analysis of a prospective cohort of patients undergoing active surveillance. Eur Urol. 2011 May;59(5):863-7. doi: 10.1016/j.eururo.2011.02.023. Epub 2011 Feb 22.
- Nguyen MM, Gill IS. Effect of renal cancer size on the prevalence of metastasis at diagnosis and mortality. J Urol. 2009 Mar;181(3):1020-7; discussion 1027. doi: 10.1016/j.juro.2008.11.023. Epub 2009 Jan 16.
- Ozsoy M, Klatte T, Waldert M, Remzi M. Surveillance for the management of small renal masses. Adv Urol. 2008:196701. doi: 10.1155/2008/196701.
- Patel N, Cranston D, Akhtar MZ, George C, Jones A, Leiblich A, Protheroe A, Sullivan M. Active surveillance of small renal masses offers short-term oncological efficacy equivalent to radical and partial nephrectomy. BJU Int. 2012 Nov;110(9):1270-5. doi: 10.1111/j.1464-410X.2012.11130.x. Epub 2012 May 4.
- Raj GV, Thompson RH, Leibovich BC, Blute ML, Russo P, Kattan MW. Preoperative nomogram predicting 12-year probability of metastatic renal cancer. J Urol. 2008 Jun;179(6):2146-51; discussion 2151. doi: 10.1016/j.juro.2008.01.101. Epub 2008 Apr 18.
- Remzi M, Ozsoy M, Klingler HC, Susani M, Waldert M, Seitz C, Schmidbauer J, Marberger M. Are small renal tumors harmless? Analysis of histopathological features according to tumors 4 cm or less in diameter. J Urol. 2006 Sep;176(3):896-9.
- Smaldone MC, Kutikov A, Egleston BL, Canter DJ, Viterbo R, Chen DY, Jewett MA, Greenberg RE, Uzzo RG. Small renal masses progressing to metastases under active surveillance: a systematic review and pooled analysis. Cancer. 2012 Feb 15;118(4):997-1006. doi: 10.1002/cncr.26369. Epub 2011 Jul 15. Review.
- Tada S, Yamagishi J, Kobayashi H, Hata Y, Kobari T. The incidence of simple renal cyst by computed tomography. Clin Radiol. 1983 Jul;34(4):437-9.
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- Volpe A, Cadeddu JA, Cestari A, Gill IS, Jewett MA, Joniau S, Kirkali Z, Marberger M, Patard JJ, Staehler M, Uzzo RG. Contemporary management of small renal masses. Eur Urol. 2011 Sep;60(3):501-15. doi: 10.1016/j.eururo.2011.05.044. Epub 2011 Jun 1. Review.
- Volpe A, Panzarella T, Rendon RA, Haider MA, Kondylis FI, Jewett MA. The natural history of incidentally detected small renal masses. Cancer. 2004 Feb 15;100(4):738-45.
- Walther MM, Choyke PL, Glenn G, Lyne JC, Rayford W, Venzon D, Linehan WM. Renal cancer in families with hereditary renal cancer: prospective analysis of a tumor size threshold for renal parenchymal sparing surgery. J Urol. 1999 May;161(5):1475-9.
- Protocollo SRM Sorv Attiva