Protocol Active Surveillance Small Renal Masses (SRMs)

February 10, 2020 updated by: Roberto Bertini, IRCCS San Raffaele

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Milan, Italy, 20132
        • Recruiting
        • IRCCS San Raffaele
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Patients with small renal masses
Active surveillance
Other: Active Surveillance

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
10 years
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
10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence and nature of disease progression during the period active surveillance
Time Frame: 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.
10 years
Evaluation of disease progression
Time Frame: 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;
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS San Raffaele

Investigators

  • Principal Investigator: Roberto Bertini, IRCCS San Raffaele

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 29, 2015

Primary Completion (Anticipated)

December 11, 2023

Study Completion (Anticipated)

December 11, 2028

Study Registration Dates

First Submitted

January 11, 2019

First Submitted That Met QC Criteria

January 11, 2019

First Posted (Actual)

January 15, 2019

Study Record Updates

Last Update Posted (Actual)

February 11, 2020

Last Update Submitted That Met QC Criteria

February 10, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Protocollo SRM Sorv Attiva

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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