Protocol Active Surveillance Small Renal Masses (SRMs)

NCT03804320 | Recruiting

• 1 other identifier: Protocollo SRM Sorv Attiva
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Cancer

Keywords

Kidney cancer; Active surveillance; Small renal masses; Partial nephrectomy

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  10 years

Secondary Outcomes (2)

• Incidence and nature of disease progression during the period active surveillance

  10 years

• Evaluation of disease progression

  10 years

Study Arms (1)

Patients with small renal masses

OTHER

Active surveillance

Other: Active Surveillance

Interventions

Active Surveillance OTHER

Patients with small renal masses

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

IRCCS San Raffaele

Milan, 20132, Italy

RECRUITING

Related Publications (25)

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MeSH Terms

Conditions

Kidney Neoplasms

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Officials

• Roberto Bertini

  IRCCS San Raffaele

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cristina Carenzi

CONTACT

carenzi.cristina@hsr.it

Roberto Bertini

CONTACT

+390226437267; bertini.roberto@hsr.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: January 11, 2019
• First Posted: January 15, 2019
• Study Start: April 29, 2015
• Primary Completion: December 11, 2023
• Study Completion (Estimated): December 11, 2028
• Last Updated: February 11, 2020

Record last verified: 2020-02

Locations

IT (1)