Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06336187 |
| Other study ID # |
UPO 2020 02 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2018 |
| Est. completion date |
December 2030 |
Study information
| Verified date |
April 2024 |
| Source |
Azienda Ospedaliero Universitaria Maggiore della Carita |
| Contact |
Alessandro Volpe, MD |
| Phone |
0321373201 |
| Email |
alessandro.volpe[@]med.uniupo.it |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
