Clinical Trials Logo

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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT06336187
Study type Observational
Source Azienda Ospedaliero Universitaria Maggiore della Carita
Contact Alessandro Volpe, MD
Phone 0321373201
Email alessandro.volpe@med.uniupo.it
Status Recruiting
Phase
Start date June 1, 2018
Completion date December 2030

See also
  Status Clinical Trial Phase
Active, not recruiting NCT04987203 - Study to Compare Tivozanib in Combination With Nivolumab to Tivozanib Monotherapy in Subjects With Renal Cell Carcinoma Phase 3
Recruiting NCT06391879 - Establishment of a Multidimensional Prediction Model for the Natural Course of VHL Disease-related Renal Cell Carcinoma
Completed NCT02526017 - Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers Phase 1
Recruiting NCT05059444 - ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation
Terminated NCT03655613 - APL-501 or Nivolumab in Combination With APL-101 in Locally Advanced or Metastatic HCC and RCC Phase 1/Phase 2
Active, not recruiting NCT03170960 - Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors Phase 1/Phase 2
Withdrawn NCT05418387 - A Social Support Intervention to Improve Treatment Among Hispanic Kidney and Liver Cancer Patients in Arizona N/A
Recruiting NCT04623502 - An Investigation of Kidney and Urothelial Tumor Metabolism in Patients Undergoing Surgical Resection and/or Biopsy N/A
Completed NCT02853344 - Study of Pembrolizumab (MK-3475) Monotherapy in Locally Advanced/Metastatic Renal Cell Carcinoma (MK-3475-427/KEYNOTE-427) Phase 2
Terminated NCT04088500 - A Study of Combination Nivolumab and Ipilimumab Retreatment in Patients With Advanced Renal Cell Carcinoma Phase 2
Completed NCT05070637 - Circulating Tumor Cell Reducing No-touch Nephrectomy N/A
Active, not recruiting NCT03634540 - A Trial of Belzutifan (PT2977, MK-6482) in Combination With Cabozantinib in Patients With Clear Cell Renal Cell Carcinoma (ccRCC) (MK-6482-003) Phase 2
Not yet recruiting NCT06049030 - A Study of HS-10516 in Patients With Advanced Clear Cell Renal Cell Carcinoma Phase 1
Completed NCT03652077 - A Safety and Tolerability Study of INCAGN02390 in Select Advanced Malignancies Phase 1
Completed NCT01358721 - Phase I Biomarker Study (BMS-936558) Phase 1
Active, not recruiting NCT04503148 - Anesthesia and Cancer Study: Renal Cell Carcinoma N/A
Completed NCT02386826 - INC280 Combined With Bevacizumab in Patients With Glioblastoma Multiforme Phase 1
Not yet recruiting NCT05808608 - A Study of AK104 Plus Axitinib in Advanced/Metastatic Special Pathological Subtypes of Renal Cell Carcinoma Phase 1/Phase 2
Withdrawn NCT03323710 - Study of Propranolol Plus Sunitinib in First-line Treatment of Metastatic Renal Cell Carcinoma Phase 2
Not yet recruiting NCT02787915 - DC1s-CTL Cellular Therapy for Renal Cell Carcinoma Phase 1/Phase 2