Renal Cell CarcinomaEASENCT06336187
European Active Surveillance of Renal Cell Carcinoma Study (EASE RCC Study)
An observational study of Renal Cell Carcinoma, run by Azienda Ospedaliero Universitaria Maggiore della Carita at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Carcinoma
- What is being tested?
- active surveillance and molecular investigation
- How many people
- 400 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2018to Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Carlotta Palumbo, MD contact
Italy1 site, 1 recruiting
- Recruiting
Ospedale Maggiore della Carità
Novara, 28100
Alessandro Volpe, MD
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Renal Cell Carcinoma
- Being tested
- active surveillance, molecular investigation
- Keywords
- active surveillance, small renal masses
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
active surveillanceOther
Follow-up visits will be scheduled 3 (optional) and 6 months after diagnosis, every 6 months up to 3 years and yearly thereafter.
molecular investigationGenetic
Transcriptomic analysis of tissues
| Study group | Role | What they receive |
|---|---|---|
| RCC (renal cell carcinoma) | Patients with small, incidentally detected, histologically confirmed renal cell carcinoma Receives: Other: active surveillance; Genetic: molecular investigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Overall survival
Measured: more than 3 years
Secondary outcomes (2)
Disease progression
tumor growth rate, progression rate, cancer-specific survival, progression-free survival
Measured: more than 3 years
Molecular pattern
identification of molecular and genetic markers that correlate with growth rate and progression
Measured: more than 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2024
- Study start1 Jun 2018
- Primary completionDec 2024 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero Universitaria Maggiore della Carita
- Sponsor type
- University, hospital or other
- Collaborators
- Università degli Studi del Piemonte Orientale Amedeo Avogadro
- Responsible party
- Principal investigator, Alessandro Volpe, Azienda Ospedaliero Universitaria Maggiore della Carita
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06336187
- Sponsor's protocol ID
- UPO 2020 02
- Acronym
- EASE
- Status last verified
- Apr 2024
- First submitted
- 22 Mar 2024
- Last updated
- 10 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- European Active Surveillance of Renal Cell Carcinoma Study (EASE RCC Study)
- ClinicalTrials.gov ID
- NCT06336187
- Acronym / sponsor ID
- EASE / UPO 2020 02
- Conditions
- Renal Cell Carcinoma
- Keywords
- active surveillance, small renal masses
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Azienda Ospedaliero Universitaria Maggiore della CaritaUniversity, hospital or other
- Collaborators
- Università degli Studi del Piemonte Orientale Amedeo Avogadro
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 28 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RCC (renal cell carcinoma) | – | Other: active surveillance, Genetic: molecular investigationPatients with small, incidentally detected, histologically confirmed renal cell carcinoma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| active surveillanceFollow-up visits will be scheduled 3 (optional) and 6 months after diagnosis, every 6 months up to 3 years and yearly thereafter. | Other | RCC (renal cell carcinoma) |
| molecular investigationTranscriptomic analysis of tissues | Genetic | RCC (renal cell carcinoma) |
Primary outcome
Overall Survival
Time frame: more than 3 years
Overall survival
2 secondary outcomes
Disease progression
Time frame: more than 3 years
Molecular pattern
Time frame: more than 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Carlotta Palumbo, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Cell Carcinoma, run by Azienda Ospedaliero Universitaria Maggiore della Carita at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alessandro Volpe, MD (0321373201 ext. +39, alessandro.volpe@med.uniupo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: more than 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2024.