NCT06336187Recruiting
European Active Surveillance of Renal Cell Carcinoma Study (EASE RCC Study)
Source: ClinicalTrials.gov · Last updated 10 Apr 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 400 (estimated)
- First submitted
- 22 Mar 2024
- Start date
- 1 Jun 2018
- Primary completion date
- Dec 2024
- Lead sponsor
- Azienda Ospedaliero Universitaria Maggiore della Carita
- Diseases
- Kidney cancer
- NCT number
- NCT06336187
What you commit to
- Study type: Observational
- Planned participants: 400
- From 1 Jun 2018 to the primary completion date, Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with concurrent systemic treatment for another cancer.
Other illness
- Presence of metastatic disease at diagnosis
- Patients with known genetic diseases associated with RCC (Von Hippel-Lindau, Birt-Hogg-Dubé, Hereditary Leiomyomatosis and Renal Cell Cancer, etc.).
Lab values
- Patients unsuitable for biopsy due to need for concomitant anticoagulation or anti-platelet drug use which cannot be transiently discontinued.
Other
- Renal tumors with a non-RCC histology (sarcomas, lymphomas, etc.).
- Tumor related symptoms at presentation.
- Patients unsuitable for biopsy due to tumor location or small tumor size.
- Patients with estimated life expectancy \< 1 year.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ospedale Maggiore della Carità Coordinator of this site? Confirm its status | Novara | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.