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

NCT06336187 | Recruiting DMC

• 1 other identifier: UPO 2020 02
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Renal Cell Carcinoma

Keywords

active surveillance; small renal masses

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  Overall survival

  more than 3 years

Secondary Outcomes (2)

• Disease progression

  more than 3 years

• Molecular pattern

  more than 3 years

Study Arms (1)

RCC (renal cell carcinoma)

Patients with small, incidentally detected, histologically confirmed renal cell carcinoma

Other: active surveillance; Genetic: molecular investigation

Interventions

active surveillance OTHER

Follow-up visits will be scheduled 3 (optional) and 6 months after diagnosis, every 6 months up to 3 years and yearly thereafter.

RCC (renal cell carcinoma)

molecular investigation GENETIC

Transcriptomic analysis of tissues

RCC (renal cell carcinoma)

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Azienda Ospedaliero Universitaria Maggiore della Carita: lead
• Università degli Studi del Piemonte Orientale Amedeo Avogadro: collaborator

Study Sites (1)

Ospedale Maggiore della Carità

Novara, 28100, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

prostate biopsy, blood sample, urine

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; 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

Central Study Contacts

Alessandro Volpe, MD

CONTACT

0321373201; alessandro.volpe@med.uniupo.it

Carlotta Palumbo, MD

CONTACT

carlotta.palumbo@uniupo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 22, 2024
• First Posted: March 28, 2024
• Study Start: June 1, 2018
• Primary Completion: December 1, 2024
• Study Completion (Estimated): December 1, 2030
• Last Updated: April 10, 2024

Record last verified: 2024-04

Locations

IT (1)