Renal Cell CancerCRYO-BO-2021NCT06829888
Percutaneous Tumor Ablation Vs Partial Nephrectomy for Small Renal Mass: the Impact of Histologic Variant and Tumor Size
An observational study of Renal Cell Cancer, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna.
Trial summary
The aim, of this study is to investigate recurrence rates in patients with T1 renal cell carcinoma (RCC) undergone partial nephrectomy (PN), radiofrequency ablation (RFA) or cryoablation (Cryo). Read more about this study
- Who is it for?
- Ages 18 to 82 years
- Conditions the study is for
- Renal Cell Cancer
- How many people
- 955 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2007to 1 Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 82 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Data from 955 consecutive patients Were retrospectively selected with clinically localized (cN0 M0) renal mass (cT1) treated with PN or percutaneous RFA or percutaneous Cryo between January 2007 and July 2019. During preoperative workout, each patient performed either with abdominal and chest contrast enhanced computed tomography or magnetic resonance imaging to stage the disease. Tumor's complexity was defined according to PADUA score.11 Overall, 139 (14.6%) patients were excluded due to incomplete clinical data (Charlson Comorbidity Index [CCI], PADUA Score, clinical size of the tumor and age were lacking in 105 [10.9%], 75 [7.8%], 2 [0.2%] and2 [0.2%] patients, respectively), resulting in a final population of 816 individuals treated with PN (N.=665), RFA (N.=68) or Cryo (N.=83).
Who may be able to join
- Radiologic diagnosis (CT chest-abdomen or MRI abdomen with contrast medium) of renal neoplasm
- Renal neoplasm of clinical stage T1a (≤4 cm) N0M0
- Age >18 years
- Informed consent
- Absence of other neoplasm
Who cannot join
- Patients refuse partial nephrectomy and/or percutaneous renal CA and are candidates for active surveillance
- Patients who are candidates for radical nephrectomy
About this study
Official title: Percutaneous Tumor Ablation Versus Partial Nephrectomy for Small Renal Mass: the Impact of Histologic Variant and Tumor Size
The aim, of this study is to investigate recurrence rates in patients with T1 renal cell carcinoma (RCC) undergone partial nephrectomy (PN), radiofrequency ablation (RFA) or cryoablation (Cryo).
Read the detailed description
The aim of our study was to compare oncologic outcomes in terms of recurrence and competing causes of mortality in patients undergone either PN, radiofrequency ablation (RFA) or cryoablation (Cryo) focusing on tumor volume and histologic variant. Retrospectively were evaluated data from 665 (81.4%), 68 (8.3%) and 83 (10.3%) patients who underwent PN, RFA and Cryo, respectively. Kaplan-Meier curves depict recurrence-free survival (RFS) rates in the overall population and after stratifying according to tumor's histology (namely, clear cell RCC and non-clear RCC) and size (namely <2 cm and 2-4 cm). Multivariable Cox regression model was used to identify predictors of recurrence. Cumulative-incidence plots evaluated disease recurrence and other causes of mortality (OCM).
- Conditions
- Renal Cell Cancer
- Keywords
- Kidney neoplasms, Nephrectomy, Radiofrequency ablation, Cryosurgery, Recurrence
- Medical subject headings
- Carcinoma, Renal Cell, Kidney Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| localized (cN0 M0) renal mass (cT1) treated with partial nephrectomy | patients with clinically localized (cN0 M0) renal mass (cT1) treated with partial nephrectomy | |
| localized (cN0 M0) renal mass (cT1) treated with percutaneus RFA | patients with clinically localized (cN0 M0) renal mass (cT1) treated with percutaneus RFA | |
| localized (cN0 M0) renal mass (cT1) treated with percutaneous cryo | patients with clinically localized (cN0 M0) renal mass (cT1) treated with percutaneous cryo |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Disease recurrence of PN vs. RFA vs. Cryo after stratifying according to histological type and tumor size.
No significant differences were recorded concerning the tumor's histology between the three groups. Patient follow-up for ablation was recommended at 3 months with abdominal CEUS and at 6 and 12 months with abdominal and chest CT or MRI followed by yearly intervals. In case of PN, the scheduled follow up included abdominal US at 6 months and abdominal and chest CT or MRI at 12 months, followed by two-yearly intervals. Local recurrence following ablation was defined as new focal enhancement in the ablation bed or enlargement of the ablation defect on follow-up imaging. Local recurrence following PN was defined as a mass in the ipsilateral kidney. Occurrence of metastatic disease was defined as extrarenal disseminated disease, with or without pathologic confirmation. Patients treated with PN experience better RFS rates as compared to both ablative techniques.However, considering patients with non-ccRCC and those with renal mass < 2cm, both PN and Cryo are valid options.
Measured: between January 2007 and July 2019
Secondary outcomes (1)
Secondary outcome was death due to cause other than RCC (OCM)
RCC was considered as the cause of death when it was registered as the first cause on death certificate, otherwise OCM was considered as the cause of death.PN proved to achieve better oncologic and survival outcomes compared to RFA and Cryo, since 91.2% vs. 67.8% and 60.2% of cases would be free from recurrence and OCM, respectively.These findings are mainly due to higher proportion of aged patients with shorter life expectancy in RFA and Cryo group than PN.
Measured: between January 2007 and July 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2025
- Study start1 Jan 2007
- Primary completion1 Jul 2019
- Study completion1 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell CancerStudies 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
- Retrospective
- Enrolment
- 955 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lorenzo Bianchi, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06829888
- Sponsor's protocol ID
- CRYO-BO-2021
- Acronym
- CRYO-BO-2021
- Status last verified
- Dec 2024
- First submitted
- 10 Jan 2025
- Last updated
- 17 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Tumor Ablation Versus Partial Nephrectomy for Small Renal Mass: the Impact of Histologic Variant and Tumor Size
- ClinicalTrials.gov ID
- NCT06829888
- Acronym / sponsor ID
- CRYO-BO-2021 / CRYO-BO-2021
- Conditions
- Renal Cell Cancer
- Keywords
- Kidney neoplasms, Nephrectomy, Radiofrequency ablation, Cryosurgery, Recurrence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 955 participants (actual)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 1 Jan 2007 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 17 Feb 2025 (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 aim, of this study is to investigate recurrence rates in patients with T1 renal cell carcinoma (RCC) undergone partial nephrectomy (PN), radiofrequency ablation (RFA) or cryoablation (Cryo).
Detailed description
The aim of our study was to compare oncologic outcomes in terms of recurrence and competing causes of mortality in patients undergone either PN, radiofrequency ablation (RFA) or cryoablation (Cryo) focusing on tumor volume and histologic variant. Retrospectively were evaluated data from 665 (81.4%), 68 (8.3%) and 83 (10.3%) patients who underwent PN, RFA and Cryo, respectively. Kaplan-Meier curves depict recurrence-free survival (RFS) rates in the overall population and after stratifying according to tumor's histology (namely, clear cell RCC and non-clear RCC) and size (namely <2 cm and 2-4 cm). Multivariable Cox regression model was used to identify predictors of recurrence. Cumulative-incidence plots evaluated disease recurrence and other causes of mortality (OCM).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| localized (cN0 M0) renal mass (cT1) treated with partial nephrectomy | – | –patients with clinically localized (cN0 M0) renal mass (cT1) treated with partial nephrectomy |
| localized (cN0 M0) renal mass (cT1) treated with percutaneus RFA | – | –patients with clinically localized (cN0 M0) renal mass (cT1) treated with percutaneus RFA |
| localized (cN0 M0) renal mass (cT1) treated with percutaneous cryo | – | –patients with clinically localized (cN0 M0) renal mass (cT1) treated with percutaneous cryo |
Who may qualify
- Ages
- 18 to 82 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Data from 955 consecutive patients Were retrospectively selected with clinically localized (cN0 M0) renal mass (cT1) treated with PN or percutaneous RFA or percutaneous Cryo between January 2007 and July 2019. During preoperative workout, each patient performed either with abdominal and chest contrast enhanced computed tomography or magnetic resonance imaging to stage the disease. Tumor's complexity was defined according to PADUA score.11 Overall, 139 (14.6%) patients were excluded due to incomplete clinical data (Charlson Comorbidity Index [CCI], PADUA Score, clinical size of the tumor and age were lacking in 105 [10.9%], 75 [7.8%], 2 [0.2%] and2 [0.2%] patients, respectively), resulting in a final population of 816 individuals treated with PN (N.=665), RFA (N.=68) or Cryo (N.=83).
Key inclusion criteria (5 listed)
- Radiologic diagnosis (CT chest-abdomen or MRI abdomen with contrast medium) of renal neoplasm
- Renal neoplasm of clinical stage T1a (≤4 cm) N0M0
- Age >18 years
- Informed consent
- Absence of other neoplasm
Key exclusion criteria (2 listed)
- Patients refuse partial nephrectomy and/or percutaneous renal CA and are candidates for active surveillance
- Patients who are candidates for radical nephrectomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
1. Disease recurrence of PN vs. RFA vs. Cryo after stratifying according to histological type and tumor size.
Time frame: between January 2007 and July 2019
No significant differences were recorded concerning the tumor's histology between the three groups. Patient follow-up for ablation was recommended at 3 months with abdominal CEUS and at 6 and 12 months with abdominal and chest CT or MRI followed by yearly intervals. In case of PN, the scheduled follow up included abdominal US at 6 months and abdominal and chest CT or MRI at 12 months, followed by two-yearly intervals. Local recurrence following ablation was defined as new focal enhancement in the ablation bed or enlargement of the ablation defect on follow-up imaging. Local recurrence following PN was defined as a mass in the ipsilateral kidney. Occurrence of metastatic disease was defined as extrarenal disseminated disease, with or without pathologic confirmation. Patients treated with PN experience better RFS rates as compared to both ablative techniques.However, considering patients with non-ccRCC and those with renal mass < 2cm, both PN and Cryo are valid options.
1 secondary outcome
Secondary outcome was death due to cause other than RCC (OCM)
Time frame: between January 2007 and July 2019
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
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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. This study is not recruiting at the moment.
Lorenzo Bianchi, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Cell Cancer, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna.
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 5 inclusion and 2 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: finished, as of the sponsor's last update on 17 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. Disease recurrence of PN vs. RFA vs. Cryo after stratifying according to histological type and tumor size. (time frame: between January 2007 and July 2019). 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 17 Feb 2025.