Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06336187
Status:
RECRUITING
Last Update Posted:
2024-04-10
First Post:
2024-03-22
Brief Title:
European Active Surveillance of Renal Cell Carcinoma Study EASE RCC Study
Sponsor:
Azienda Ospedaliero Universitaria Maggiore della Carita
Organization:
Azienda Ospedaliero Universitaria Maggiore della Carita
Study Overview
Official Title:
European Active Surveillance of Renal Cell Carcinoma Study EASE RCC Study
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EASE
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 cores 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
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 cores 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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None