Renal TumorNCT04506671
Percutaneous Cryoablation Versus Partial Nephrectomy for T1b Renal Tumor
A study testing Renal biopsy, Cryoablation and Partial nephrectomy in people with Renal Tumor, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.
Trial summary
The aim of our study is to assess the long-term oncological and functional outcomes of cryoablation for T1b renal tumors, as well as such important parameters as the patient's quality of life after treatment, and to compare the results with those after partial nephrectomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Tumor
- What is being tested?
- Renal biopsy, Cryoablation and Partial nephrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteRussia
- Study dates
- 22 May 2020to 22 Jun 2025
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- •CT-confirmed renal mass > 4 to 7 cm (T1b)
Who cannot join
- Multiple renal tumors;
- Recurrence of renal tumor;
- Intolerance to iodine-containing contrast agents;
- Pregnancy;
- Patients with Bosniak 4 cysts
- Presence of other oncological diseases;
- Impossibility of organ-preserving treatment due to the proximity of the tumor to the vessels or the calyx-pelvic system
- Absence of malignant pathology based on prior biopsy.
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
Institute for Urology and Reproductive Health, Sechenov University.
Moscow, 119991
Dmitry Enikeev, M.D., Ph.D, +7 9670897154, enikeev-dv@1msmu.ru
Mark Taratkin, MD, +7 9670897154, marktaratkin@gmail.com
About this study
Official title: A Prospective, Non-randomized, in Parallel Groups Study Evaluating the Efficacy and Safety of Percutaneous Cryoablation and Partial Nephrectomy in Localized T1b Renal Tumor
The aim of our study is to assess the long-term oncological and functional outcomes of cryoablation for T1b renal tumors, as well as such important parameters as the patient's quality of life after treatment, and to compare the results with those after partial nephrectomy.
- Conditions
- Renal Tumor
- Being tested
- Renal biopsy, Cryoablation, Partial nephrectomy
- Keywords
- Cryoablation, Renal cancer, Partial nephrectomy
- Medical subject headings
- Carcinoma, Renal Cell, Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renal biopsyProcedure or surgery
Renal biopsy will be performed prior to the cryoablation on the basis of the center and according to the current protocols
CryoablationProcedure or surgery
Cryoablation under CT guidance will be performed on the basis of the center and according to the current protocols
Partial nephrectomyProcedure or surgery
Partial nephrectomy will be performed on the basis of the center and according to the current protocols
| Study group | Role | What they receive |
|---|---|---|
| Cryoablation group | Experimental | Patients with T1b renal tumor and ECOQ>20 Receives: Procedure: Renal biopsy; Procedure: Cryoablation |
| Partial nephrectomy group | Active comparator | Patients with T1b renal tumor Receives: Procedure: Partial nephrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local recurrence
Local recurrance will be evaluated with CT after 6 months, a year, then annually - up to 5 years after the treatment
Measured: 5 years
Secondary outcomes (7)
Metastatic progression
Presence of metastases will be evaluated with CT after 6 months, a year, then annually - up to 5 years after the treatment
Measured: 5 years
Quality of life assessment: The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ C-30)
Quality of life will be assessed using scales EORTC QLQ C-30, ranging from 1 to 100, where higher score indicating a better Quality of Life
Measured: 5 years
Renal function
Renal function will be evaluated with eGFR
Measured: 5 years
Rate of adverse events
Rate of intra- and postoperative adverse events will be assessed according to Clavien-Dindo grade system
Measured: 3 months
Blood loss
Pre- and postoperative Hb level
Measured: 12 months
Length of hospital stay
Number of days spent in hospital
Measured: 1 month
Pain score
Pain score will be assessed using visual analogue scale
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2020
- Study start22 May 2020
- Primary completion22 May 2025 (estimated)
- Study completion22 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal TumorStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 142 participants (estimated)
Sponsor and investigators
- Lead sponsor
- I.M. Sechenov First Moscow State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dmitry Enikeev, MD, PhD, I.M. Sechenov First Moscow State Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04506671
- Sponsor's protocol ID
- CA_vs_PN
- Status last verified
- Jul 2021
- First submitted
- 6 Aug 2020
- Last updated
- 28 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Non-randomized, in Parallel Groups Study Evaluating the Efficacy and Safety of Percutaneous Cryoablation and Partial Nephrectomy in Localized T1b Renal Tumor
- ClinicalTrials.gov ID
- NCT04506671
- Acronym / sponsor ID
- CA_vs_PN
- Conditions
- Renal Tumor
- Keywords
- Cryoablation, Renal cancer, Partial nephrectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- I.M. Sechenov First Moscow State Medical UniversityUniversity, hospital or other
- Study start
- 22 May 2020 (actual)
- Primary completion
- 22 May 2025 (estimated)
- Study completion
- 22 Jun 2025 (estimated)
- First posted
- 10 Aug 2020 (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 our study is to assess the long-term oncological and functional outcomes of cryoablation for T1b renal tumors, as well as such important parameters as the patient's quality of life after treatment, and to compare the results with those after partial nephrectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cryoablation group | Experimental | Procedure: Renal biopsy, Procedure: CryoablationPatients with T1b renal tumor and ECOQ>20 |
| Partial nephrectomy group | Active comparator | Procedure: Partial nephrectomyPatients with T1b renal tumor |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- •CT-confirmed renal mass > 4 to 7 cm (T1b)
Key exclusion criteria (8 listed)
- Multiple renal tumors;
- Recurrence of renal tumor;
- Intolerance to iodine-containing contrast agents;
- Pregnancy;
- Patients with Bosniak 4 cysts
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 |
|---|---|---|
| Renal biopsyRenal biopsy will be performed prior to the cryoablation on the basis of the center and according to the current protocols | Procedure or surgery | Cryoablation group |
| CryoablationCryoablation under CT guidance will be performed on the basis of the center and according to the current protocols | Procedure or surgery | Cryoablation group |
| Partial nephrectomyPartial nephrectomy will be performed on the basis of the center and according to the current protocols | Procedure or surgery | Partial nephrectomy group |
Primary outcome
Local recurrence
Time frame: 5 years
Local recurrance will be evaluated with CT after 6 months, a year, then annually - up to 5 years after the treatment
7 secondary outcomes
Metastatic progression
Time frame: 5 years
Quality of life assessment: The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ C-30)
Time frame: 5 years
Renal function
Time frame: 5 years
Rate of adverse events
Time frame: 3 months
Blood loss
Time frame: 12 months
Length of hospital stay
Time frame: 1 month
Pain score
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2021.
- Individual participant dataSharing planned: No
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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.
Institute for Urology and Reproductive Health, Sechenov University.
Moscow, Russia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Renal biopsy, Cryoablation and Partial nephrectomy in people with Renal Tumor, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.
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 1 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: status not confirmed, as of the sponsor's last update on 28 Jul 2021. 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 Russia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local recurrence (time frame: 5 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 28 Jul 2021.