European Active Surveillance of Renal Cell Carcinoma Study (EASE RCC Study) (EASE)

The goal of this observational, prospective, multi-national clinical study is to assess overall survival of patients who are diagnosed with incidental, histologically (biopsy) confirmed, <4 cm Renal Cell Carcinoma (RCC) and are managed conservatively with active surveillance.

The primary endpoint is overall survival. The Secondary endpoints are tumor growth rate, progression rate, cancer-specific survival, progression-free survival, identification of clinical and pathological variables and molecular and genetic markers that correlate with growth rate and progression.

The main question it aims to answer is: patients with RCC (less than 4 cm) diagnosis can be managed with active surveillance instead treated with invasive curative procedure? For all participants a percutaneous biopsy of the renal mass will be arranged in all cases to histologically confirm the diagnosis of RCC (unless a diagnostic biopsy has been acquired in the previous 6 months). As a minimum, two samples will be used for diagnostic purposes while remaining core(s) will be preserved for molecular studies.

Then, all patients will be under active surveillance, which is defined as the initial monitoring of tumor size by serial abdominal imaging (US, CT, or MRI) Follow-up visits will be scheduled 3 (optional) and 6 months after diagnosis, every 6 months up to 3 years and yearly thereafter. A follow-up visit will also be carried out at the time of progression when it occurs. Follow-up visits will include medical history and physical examination (optional), and assessment of concurrent medications, blood and urine collection and storage if participating in translational activities, cross-sectional abdominal and chest imaging exams.

Follow-up percutaneous biopsies of the renal tumor are not mandatory, but can be performed when considered clinically important.

Study Overview

• Status: Recruiting
• Conditions: Renal Cell Carcinoma
• Intervention / Treatment: Other: active surveillance; Genetic: molecular investigation

Detailed Description

Rationale: Active surveillance can be considered a reasonable strategy for elderly patients with small renal tumors or patients with significant comorbidities who are not good surgical candidates. However, most available studies on active surveillance include small renal tumors that were not histologically confirmed as renal cell carcinoma (RCCs), including a proportion of benign tumors. Furthermore, follow-up protocol and indications to delayed intervention during active surveillance have not been generally standardized. There is a clear need of information on the growth rate and oncological outcomes of histologically confirmed RCCs by percutaneous biopsy at diagnosis and on the results of a standardized protocol of active surveillance of small RCCs.

Furthermore, if the measurement of tumor growth rate seems to be helpful for initial conservative management of patients with incidentally diagnosed small renal tumors, it is necessary to identify reliable genetic or molecular serum, urine or tissue markers that can differentiate small renal tumors with different inherent aggressiveness and metastatic potential at diagnosis, thereby enabling the urologist to choose the most suitable conservative or active, individualized management approach for each patient.

This is a prospective, multi-national clinical study conducted in European countries by hospital based urologists. A total of 400 patients with small, incidentally detected, histologically confirmed RCCs will be included and data related to the oncological outcomes of an active surveillance approach will be collected.

After ethics committee approval, according to local requirements, and written patient informed consent has been obtained, patient enrolment can be started.

Primary endpoint is overall survival. Secondary endpoints are tumor growth rate, progression rate, cancer-specific survival, progression-free survival, identification of clinical and pathological variables and molecular and genetic markers that correlate with growth rate and progression.

• Study Type: Observational
• Enrollment (Estimated): 400

Contacts and Locations

• Study Contact: Name: Alessandro Volpe, MD; Phone Number: +39 0321373201; Email: alessandro.volpe@med.uniupo.it
• Study Contact Backup: Name: Carlotta Palumbo, MD; Email: carlotta.palumbo@uniupo.it

Study Locations

• Italy
  • Novara, Italy, 28100
    • Recruiting
    • Ospedale Maggiore della Carita
    • Contact: Alessandro Volpe, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This is a prospective, multi-national clinical study conducted in European countries by hospital based urologists. Patients with small, incidentally detected, histologically confirmed renal cell carcinoma will be included and data related to the oncological outcomes of an active surveillance approach will be collected.

Description

Inclusion Criteria:

• Males or females, age ≥ 18 years
• Incidental diagnosis at imaging (ultrasonography, CT, MRI) of a solid renal mass < 4 cm in maximum diameter.
• Histologically confirmed RCC by percutaneous needle biopsy at diagnosis. All RCC subtypes are eligible for the study.
• Patients unfit for active treatment due to advanced age, or co-morbidity, or choosing to avoid active treatment.
• Signed Informed consent.
• Preparedness to comply with percutaneous tumor biopsy and a close follow-up protocol

Exclusion Criteria:

• Renal tumors with a non-RCC histology (sarcomas, lymphomas, etc.).
• Presence of metastatic disease at diagnosis
• Tumor related symptoms at presentation.
• Patients with known genetic diseases associated with RCC (Von Hippel-Lindau, Birt-Hogg-Dubé, Hereditary Leiomyomatosis and Renal Cell Cancer, etc.).
• Patients unsuitable for biopsy due to need for concomitant anticoagulation or anti-platelet drug use which cannot be transiently discontinued.
• Patients unsuitable for biopsy due to tumor location or small tumor size.
• Patients with concurrent systemic treatment for another cancer.
• Patients with estimated life expectancy < 1 year.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
RCC (renal cell carcinoma); Patients with small, incidentally detected, histologically confirmed renal cell carcinoma	Other: active surveillance; Follow-up visits will be scheduled 3 (optional) and 6 months after diagnosis, every 6 months up to 3 years and yearly thereafter.; Genetic: molecular investigation; Transcriptomic analysis of tissues

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival	Overall survival	more than 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease progression	tumor growth rate, progression rate, cancer-specific survival, progression-free survival	more than 3 years
Molecular pattern	identification of molecular and genetic markers that correlate with growth rate and progression	more than 3 years

Collaborators and Investigators

• Sponsor: Azienda Ospedaliero Universitaria Maggiore della Carita
• Collaborators: Università degli Studi del Piemonte Orientale "Amedeo Avogadro"

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2018
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2030

Study Registration Dates

• First Submitted: March 22, 2024
• First Submitted That Met QC Criteria: March 22, 2024
• First Posted (Actual): March 28, 2024

Study Record Updates

• Last Update Posted (Actual): April 10, 2024
• Last Update Submitted That Met QC Criteria: April 9, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: active surveillance; small renal masses
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Kidney Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Carcinoma, Renal Cell; Carcinoma
• Other Study ID Numbers: UPO 2020 02

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