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CompletedNCT02850809RF-REINUpdated Apr 28, 2023

Evaluation of the Efficacy of Radiofrequency in the Treatment of Renal Tumors

An observational study in Renal Cell Carcinoma, sponsored by University Hospital, Bordeaux. Completed at 8 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-28.

Sponsored by University Hospital, Bordeaux · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
310
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Renal Cell Carcinoma

Keywords

  • radiofrequency ablation
  • complications
03

In context

Carcinoma, Renal Cell

1,964 studies on the registry are indexed under Carcinoma, Renal Cell; 377 are open to participants now.

This study's enrollment of 310 is above the median of 146 across 360 observational studies indexed under Carcinoma, Renal Cell.

Browse Carcinoma, Renal Cell studies →

Lead sponsor

University Hospital, Bordeaux is the lead sponsor of 783 studies on the registry; 188 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

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).

Inclusion criteria

  • 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)

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
310 participants (actual)
Patient registry
No

Groups and cohorts

  • patients

    Treated by percutaneous image-guided radiofrequency for renal tumor

06

What researchers measure

Primary outcomes

  1. Rate of local efficacy of RFA treatment

    Time frame: 60 months after the RFA treatment (D0)

Secondary outcomes

  1. Overall success

    Time frame: At 60 months after the RFA treatment (D0)

  2. No recurrence of RCC

    Time frame: At 60 months after the RFA treatment (D0)

  3. Tolerance of the treatment

    Time frame: At D0, 48 hours, 6, 12, 24, 36, 48 and 60 months after the RFA treatment (D0)

07

Study locations

8 sites
  • CHU de Bordeaux - Pellegrin
    Bordeaux, France
  • CHU de Grenoble
    Grenoble, France
  • CHRU de Lille - Hôpital Claude HURIEZ
    Lille, France
  • Hospices Civils de Lyon
    Lyon, France
  • Assistance Publique - Hôpitaux de Marseille
    Marseille, France
  • Assistance Publique - Hôpitaux de Paris (AP-HP) - Hopital Necker
    Paris, France
  • CHU de Strasbourg
    Strasbourg, France
  • CHU de Toulouse, Hopital de Rangueil
    Toulouse, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 28, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02850809
Lead sponsor
University Hospital, Bordeaux
Collaborators
Ministry for Health and Solidarity, France
Responsible party
Sponsor
First posted
Aug 1, 2016
Start date
Oct 2010
Primary completion
Dec 2015
Completion
Dec 2015
Last update
Apr 28, 2023

Study contacts

Paul PEREZ, MD
study chair · University Hospital Bordeaux, France
Nicolas GRENIER, Prof
principal investigator · University Hospital Bordeaux, France

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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