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NCT02870621 Clinical Trial

Volume of Perirenal Fat and Chronic Kidney Disease

Nephrectomy Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02870621
Other study ID # 12-PP-06
Secondary ID
Status Recruiting
Phase N/A
First received July 29, 2016
Last updated August 12, 2016
Start date July 2012

Study information
Verified date July 2016
Source Centre Hospitalier Universitaire de Nice
Contact Guillaume FAVRE, Dr
Phone 4 92 03 88 24
Email favre.g@chu-nice.fr
Is FDA regulated No
Health authority France: Commission nationale de l'informatique et des libertés
Study type Observational

Clinical Trial Summary

The perirenal fat may alter renal function by secreting fibrotic inflammatory agents when accumulates during obesity. Nephrectomy for renal tumor is a model that would provide tissue samples to test this hypothesis. Renal tumor could itself be responsible for inflammation and fibrosis in its environment. This study aims to measure the influence of the tumor on his kidney Environment and fat and define molecular markers not influenced by renal tumor. The main objective is to compare the inflammation of the perirenal fat taken in two locations in the same patient, in contact and 4 cm from the outer edge of the tumor, each patient as his own control. The secondary objective is to compare the degree of interstitial fibrosis of the renal cortex in the same sampling methods.

Recruitment information / eligibility
Status Recruiting
Enrollment 12
Est. completion date
Est. primary completion date September 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Age 18 years or more

- Indication nephrectomy for kidney tumor

- Stadium T1a, T1b or T2 and M0 according to the TNM (Tumor Nodes Metastasis) classification of tumors

Exclusion Criteria:

- Nephrectomy indication for chronic pyelonephritis

- Asian topic because of the difference threshold values used to characterize the metabolic syndrome in this population

- Diabetes type I or II due to a high score of renal interstitial fibrosis

- Infection with HIV (Human immunodeficiency virus)

- Partial nephrectomy (a part of the kidney on the side of the tumor is left in place)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
France CHU de Nice Nice

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Numbers of renal interstitial fibrosis 1 day No
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