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

NCT02850809 | Completed

• 1 other identifier: CHUBX 2010/08
• Study Type: observational
• Target: 310
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

Renal Cell Carcinoma

Keywords

radiofrequency ablation; complications

Outcome Measures

Primary Outcomes (1)

• Rate of local efficacy of RFA treatment

  60 months after the RFA treatment (D0)

Secondary Outcomes (3)

• Overall success

  At 60 months after the RFA treatment (D0)

• No recurrence of RCC

  At 60 months after the RFA treatment (D0)

• Tolerance of the treatment

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

Study Arms (1)

patients

Treated by percutaneous image-guided radiofrequency for renal tumor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Bordeaux: lead
• Ministry for Health and Solidarity, France: collaborator

Study Sites (8)

CHU de Bordeaux - Pellegrin

Bordeaux, France

Location

CHU de Grenoble

Grenoble, France

Location

CHRU de Lille - Hôpital Claude HURIEZ

Lille, France

Location

Hospices Civils de Lyon

Lyon, France

Location

Assistance Publique - Hôpitaux de Marseille

Marseille, France

Location

Assistance Publique - Hôpitaux de Paris (AP-HP) - Hopital Necker

Paris, France

Location

CHU de Strasbourg

Strasbourg, France

Location

CHU de Toulouse, Hopital de Rangueil

Toulouse, France

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Paul PEREZ, MD

  University Hospital Bordeaux, France

  STUDY CHAIR

• Nicolas GRENIER, Prof

  University Hospital Bordeaux, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2016
• First Posted: August 1, 2016
• Study Start: October 1, 2010
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: April 28, 2023

Record last verified: 2023-04

Locations

FR (8)