Renal Cell CarcinomaRF-REINNCT02850809
Evaluation of the Efficacy of Radiofrequency in the Treatment of Renal Tumors
An observational study of Renal Cell Carcinoma, run by University Hospital, Bordeaux at 8 sites in France.
Trial summary
Multi-institutional registry on a cohort of 310 patients with biopsy-proven renal cell carcinoma treated by Radiofrequency ablation. All patients will be included consecutively and retrospectively in all centers to obtain the required number of patient followed during 5 years. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Carcinoma
- How many people
- 310 participants
- Where
- 8 sitesFrance
- Study dates
- Oct 2010to Dec 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The population concerned by the study consists in patients treated by percutaneous image-guided radiofrequency for renal tumor. The treated tumors have a diameter ≤ 4 cm characterized by computed tomography (CT) or Magnetic resonance imaging (MRI).
Who may be able to join
- Patient treated with percutaneous RFA
- Patient with diagnosis of renal masses with a maximum of 3 masses treated during the ablation
- The diameter of the tumor must be ≤ 40 mm, characterized by CT-scan or MRI
- The histology of the tumor must be biopsy-proven or the patient must have previous surgical ablation of renal tumor (ipsi or contralateral)
Who cannot join
- Patient treated by surgery or laparoscopy
- Benign tumors
- No histological diagnosis (no biopsy or no previous treated renal carcinoma)
- Patient having secondary malignant sites, ganglions or visceral metastatic cells or endo-venous extend at the time of RFA
- Patient having a diagnosis of primary or secondary extra-renal tumor location and not into remission
- Patients treated with antiangiogenic drugs during the 6 months prior RFA.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
France8 sites
CHU de Bordeaux - Pellegrin
Bordeaux
CHU de Grenoble
Grenoble
CHRU de Lille - Hôpital Claude HURIEZ
Lille
Hospices Civils de Lyon
Lyon
Assistance Publique - Hôpitaux de Marseille
Marseille
Assistance Publique - Hôpitaux de Paris (AP-HP) - Hopital Necker
Paris
CHU de Strasbourg
Strasbourg
CHU de Toulouse, Hopital de Rangueil
Toulouse
About this study
Official title: Evaluation of the Efficacy of Radiofrequency Ablation in the Treatment of Renal Tumors: Prospective Observational Study
Multi-institutional registry on a cohort of 310 patients with biopsy-proven renal cell carcinoma treated by Radiofrequency ablation. All patients will be included consecutively and retrospectively in all centers to obtain the required number of patient followed during 5 years.
Read the detailed description
Radiofrequency ablation (RFA) of renal cell carcinoma (RCC) is actually used in elderly patients with small renal tumors (diameter ≤ 4 cm) and presenting a high risk of surgery (due to co-morbidity) and/or reduced renal function. RFA is a minimally invasive technique, considered as an alternative to surgery to limit morbidity and to preserve kidney function. The technique is well known and has proven his efficacy for the treatment of small tumors.
An enlargement of the indications of RFA to patient without contra-indication to surgery will depend on the efficacy of the technique.
The main objective of the study is to evaluate the local efficacy of the ablation based on the technical success, and on the evaluation of local cancer recurrence over 5 years.
- Conditions
- Renal Cell Carcinoma
- Keywords
- radiofrequency ablation, complications
- 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.
| Study group | Role | What they receive |
|---|---|---|
| patients | Treated by percutaneous image-guided radiofrequency for renal tumor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of local efficacy of RFA treatment
Measured: 60 months after the RFA treatment (D0)
Secondary outcomes (3)
Overall success
Measured: At 60 months after the RFA treatment (D0)
No recurrence of RCC
Measured: At 60 months after the RFA treatment (D0)
Tolerance of the treatment
Measured: At D0, 48 hours, 6, 12, 24, 36, 48 and 60 months after the RFA treatment (D0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2016 (estimated)
- Study startOct 2010
- Primary completionDec 2015
- Study completionDec 2015
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.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- 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
- 310 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry for Health and Solidarity, France
- Responsible party
- Sponsor
- Investigators
- Paul PEREZ, MD, Study chair, University Hospital Bordeaux, FranceNicolas GRENIER, Prof, Principal investigator, University Hospital Bordeaux, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02850809
- Sponsor's protocol ID
- CHUBX 2010/08
- Acronym
- RF-REIN
- Status last verified
- Apr 2023
- First submitted
- 25 Jul 2016
- Last updated
- 28 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Radiofrequency Ablation in the Treatment of Renal Tumors: Prospective Observational Study
- ClinicalTrials.gov ID
- NCT02850809
- Acronym / sponsor ID
- RF-REIN / CHUBX 2010/08
- Conditions
- Renal Cell Carcinoma
- Keywords
- radiofrequency ablation, complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 310 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- Ministry for Health and Solidarity, France
- Study start
- Oct 2010
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 1 Aug 2016 (estimated)
- 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.
Multi-institutional registry on a cohort of 310 patients with biopsy-proven renal cell carcinoma treated by Radiofrequency ablation. All patients will be included consecutively and retrospectively in all centers to obtain the required number of patient followed during 5 years.
Detailed description
Radiofrequency ablation (RFA) of renal cell carcinoma (RCC) is actually used in elderly patients with small renal tumors (diameter ≤ 4 cm) and presenting a high risk of surgery (due to co-morbidity) and/or reduced renal function. RFA is a minimally invasive technique, considered as an alternative to surgery to limit morbidity and to preserve kidney function. The technique is well known and has proven his efficacy for the treatment of small tumors.
An enlargement of the indications of RFA to patient without contra-indication to surgery will depend on the efficacy of the technique.
The main objective of the study is to evaluate the local efficacy of the ablation based on the technical success, and on the evaluation of local cancer recurrence over 5 years.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients | – | –Treated by percutaneous image-guided radiofrequency for renal tumor |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population concerned by the study consists in patients treated by percutaneous image-guided radiofrequency for renal tumor. The treated tumors have a diameter ≤ 4 cm characterized by computed tomography (CT) or Magnetic resonance imaging (MRI).
Key inclusion criteria (4 listed)
- Patient treated with percutaneous RFA
- Patient with diagnosis of renal masses with a maximum of 3 masses treated during the ablation
- The diameter of the tumor must be ≤ 40 mm, characterized by CT-scan or MRI
- The histology of the tumor must be biopsy-proven or the patient must have previous surgical ablation of renal tumor (ipsi or contralateral)
Key exclusion criteria (6 listed)
- Patient treated by surgery or laparoscopy
- Benign tumors
- No histological diagnosis (no biopsy or no previous treated renal carcinoma)
- Patient having secondary malignant sites, ganglions or visceral metastatic cells or endo-venous extend at the time of RFA
- Patient having a diagnosis of primary or secondary extra-renal tumor location and not into remission
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
Rate of local efficacy of RFA treatment
Time frame: 60 months after the RFA treatment (D0)
3 secondary outcomes
Overall success
Time frame: At 60 months after the RFA treatment (D0)
No recurrence of RCC
Time frame: At 60 months after the RFA treatment (D0)
Tolerance of the treatment
Time frame: At D0, 48 hours, 6, 12, 24, 36, 48 and 60 months after the RFA treatment (D0)
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 28 Apr 2023.
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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.
Paul PEREZ, MD study chair
University Hospital Bordeaux, France
Nicolas GRENIER, Prof principal investigator
University Hospital Bordeaux, France
8 sites 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 University Hospital, Bordeaux at 8 sites in France.
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 4 inclusion and 6 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 28 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France. 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?
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?
Rate of local efficacy of RFA treatment (time frame: 60 months after the RFA treatment (D0)). 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 Apr 2023.