Kidney CancerNCT03804320
Protocol Active Surveillance Small Renal Masses (SRMs)
A study testing Active Surveillance in people with Kidney Cancer, run by IRCCS San Raffaele at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Kidney Cancer
- What is being tested?
- Active Surveillance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteItaly
- Study dates
- 29 Apr 2015to 11 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
- 4) diagnosis of monolateral, monofocal, and first-rate solid renal mass less than 2 cm; 5) absence of symptoms due to renal tumor pathology.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Cristina Carenzi contact
Italy1 site, 1 recruiting
- Recruiting
IRCCS San Raffaele
Milan, 20132
Roberto Bertini, +390226437267, bertini.roberto@hsr.it
About this study
Official title: Sorveglianza Attiva Dei Tumori Renali T1a Uguali o Inferiori a 2 cm
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.
- Conditions
- Kidney Cancer
- Being tested
- Active Surveillance
- Keywords
- Kidney cancer, Active surveillance, Small renal masses, Partial nephrectomy
- Medical subject headings
- Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active SurveillanceOther
| Study group | Role | What they receive |
|---|---|---|
| Patients with small renal masses | Other | Active surveillance Receives: Other: Active Surveillance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the therapeutic efficacy of active surveillance for small renal masses
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.
Measured: 10 years
Evaluate the proportion of patients who do not undergone active treatment
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
Measured: 10 years
Secondary outcomes (2)
Incidence and nature of disease progression during the period active surveillance
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.
Measured: 10 years
Evaluation of disease progression
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;
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2019
- Study start29 Apr 2015
- Primary completion11 Dec 2023 (estimated)
- Study completion11 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Kidney CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roberto Bertini, IRCCS San Raffaele
- Investigators
- Roberto Bertini, Principal investigator, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03804320
- Sponsor's protocol ID
- Protocollo SRM Sorv Attiva
- Status last verified
- Feb 2020
- First submitted
- 11 Jan 2019
- Last updated
- 11 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 21296855Volpe 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. doi: 10.1002/cncr.20025.
PubMed 14770429Lane BR, Abouassaly R, Gao T, Weight CJ, Hernandez AV, Larson BT, Kaouk JH, Gill IS, Campbell SC. Active treatment of localized renal tumors may not impact overall survival in patients aged 75 years or older. Cancer. 2010 Jul 1;116(13):3119-26. doi: 10.1002/cncr.25184.
PubMed 20564627Tada 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. doi: 10.1016/s0009-9260(83)80238-4.
PubMed 6872451Lane 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.
PubMed 21849192Thompson RH, Kaag M, Vickers A, Kundu S, Bernstein M, Lowrance W, Galvin D, Dalbagni G, Touijer K, Russo P. Contemporary use of partial nephrectomy at a tertiary care center in the United States. J Urol. 2009 Mar;181(3):993-7. doi: 10.1016/j.juro.2008.11.017. Epub 2009 Jan 16.
PubMed 19150552Dulabon LM, Lowrance WT, Russo P, Huang WC. Trends in renal tumor surgery delivery within the United States. Cancer. 2010 May 15;116(10):2316-21. doi: 10.1002/cncr.24965.
PubMed 20225227Campbell SC, Novick AC, Belldegrun A, Blute ML, Chow GK, Derweesh IH, Faraday MM, Kaouk JH, Leveillee RJ, Matin SF, Russo P, Uzzo RG; Practice Guidelines Committee of the American Urological Association. Guideline for management of the clinical T1 renal mass. J Urol. 2009 Oct;182(4):1271-9. doi: 10.1016/j.juro.2009.07.004. Epub 2009 Aug 14. No abstract available.
PubMed 19683266Klinghoffer Z, Tarride JE, Novara G, Ficarra V, Kapoor A, Shayegan B, Braga LH. Cost-utility analysis of radical nephrectomy versus partial nephrectomy in the management of small renal masses: Adjusting for the burden of ensuing chronic kidney disease. Can Urol Assoc J. 2013 Mar-Apr;7(3-4):108-13. doi: 10.5489/cuaj.502.
PubMed 23671525Lane 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. doi: 10.1016/j.juro.2007.03.106. Epub 2007 Jun 11.
PubMed 17561141Remzi 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. doi: 10.1016/j.juro.2006.04.047.
PubMed 16890647Frank I, Blute ML, Cheville JC, Lohse CM, Weaver AL, Zincke H. Solid renal tumors: an analysis of pathological features related to tumor size. J Urol. 2003 Dec;170(6 Pt 1):2217-20. doi: 10.1097/01.ju.0000095475.12515.5e.
PubMed 14634382Volpe 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.
PubMed 21664040Hollingsworth JM, Miller DC, Daignault S, Hollenbeck BK. Rising incidence of small renal masses: a need to reassess treatment effect. J Natl Cancer Inst. 2006 Sep 20;98(18):1331-4. doi: 10.1093/jnci/djj362.
PubMed 16985252Raj 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.
PubMed 18423735
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sorveglianza Attiva Dei Tumori Renali T1a Uguali o Inferiori a 2 cm
- ClinicalTrials.gov ID
- NCT03804320
- Acronym / sponsor ID
- Protocollo SRM Sorv Attiva
- Conditions
- Kidney Cancer
- Keywords
- Kidney cancer, Active surveillance, Small renal masses, Partial nephrectomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 29 Apr 2015 (actual)
- Primary completion
- 11 Dec 2023 (estimated)
- Study completion
- 11 Dec 2028 (estimated)
- First posted
- 15 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with small renal masses | Other | Other: Active SurveillanceActive surveillance |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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;
- 4) diagnosis of monolateral, monofocal, and first-rate solid renal mass less than 2 cm; 5) absence of symptoms due to renal tumor pathology.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active Surveillance | Other | Patients with small renal masses |
Primary outcome
Evaluate the therapeutic efficacy of active surveillance for small renal masses
Time frame: 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
Time frame: 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
2 secondary outcomes
Incidence and nature of disease progression during the period active surveillance
Time frame: 10 years
Evaluation of disease progression
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2020.
- Background: PubMed 21296855Jemal 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.
- Background: PubMed 14770429Volpe 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. doi: 10.1002/cncr.20025.
- Background: PubMed 20564627Lane BR, Abouassaly R, Gao T, Weight CJ, Hernandez AV, Larson BT, Kaouk JH, Gill IS, Campbell SC. Active treatment of localized renal tumors may not impact overall survival in patients aged 75 years or older. Cancer. 2010 Jul 1;116(13):3119-26. doi: 10.1002/cncr.25184.
- Background: PubMed 6872451Tada 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. doi: 10.1016/s0009-9260(83)80238-4.
- Background: PubMed 21849192Lane 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.
- Background: PubMed 19150552Thompson RH, Kaag M, Vickers A, Kundu S, Bernstein M, Lowrance W, Galvin D, Dalbagni G, Touijer K, Russo P. Contemporary use of partial nephrectomy at a tertiary care center in the United States. J Urol. 2009 Mar;181(3):993-7. doi: 10.1016/j.juro.2008.11.017. Epub 2009 Jan 16.
- Background: PubMed 20225227Dulabon LM, Lowrance WT, Russo P, Huang WC. Trends in renal tumor surgery delivery within the United States. Cancer. 2010 May 15;116(10):2316-21. doi: 10.1002/cncr.24965.
- Background: PubMed 19683266Campbell SC, Novick AC, Belldegrun A, Blute ML, Chow GK, Derweesh IH, Faraday MM, Kaouk JH, Leveillee RJ, Matin SF, Russo P, Uzzo RG; Practice Guidelines Committee of the American Urological Association. Guideline for management of the clinical T1 renal mass. J Urol. 2009 Oct;182(4):1271-9. doi: 10.1016/j.juro.2009.07.004. Epub 2009 Aug 14. No abstract available.
- Background: PubMed 23671525Klinghoffer Z, Tarride JE, Novara G, Ficarra V, Kapoor A, Shayegan B, Braga LH. Cost-utility analysis of radical nephrectomy versus partial nephrectomy in the management of small renal masses: Adjusting for the burden of ensuing chronic kidney disease. Can Urol Assoc J. 2013 Mar-Apr;7(3-4):108-13. doi: 10.5489/cuaj.502.
- Background: PubMed 17561141Lane 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. doi: 10.1016/j.juro.2007.03.106. Epub 2007 Jun 11.
- Background: PubMed 16890647Remzi 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. doi: 10.1016/j.juro.2006.04.047.
- Background: PubMed 14634382Frank I, Blute ML, Cheville JC, Lohse CM, Weaver AL, Zincke H. Solid renal tumors: an analysis of pathological features related to tumor size. J Urol. 2003 Dec;170(6 Pt 1):2217-20. doi: 10.1097/01.ju.0000095475.12515.5e.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cristina Carenzi contact
Roberto Bertini principal investigator
IRCCS San Raffaele
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Surveillance in people with Kidney Cancer, run by IRCCS San Raffaele at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cristina Carenzi (carenzi.cristina@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the therapeutic efficacy of active surveillance for small renal masses (time frame: 10 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03804320, which also lists 25 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2020.