Volume of Perirenal Fat and Chronic Kidney Disease
1 other identifier
observational
12
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2012
CompletedFirst Submitted
Initial submission to the registry
July 29, 2016
CompletedFirst Posted
Study publicly available on registry
August 17, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedAugust 17, 2016
July 1, 2016
4.2 years
July 29, 2016
August 12, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Numbers of renal interstitial fibrosis
1 day
Eligibility Criteria
Recruitment is in hospital, all patients being hospitalized in case of nephrectomy for kidney cancer. The treatment will be done like habitually and fat will be sample.
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU de Nice
Nice, France
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 29, 2016
First Posted
August 17, 2016
Study Start
July 1, 2012
Primary Completion
September 1, 2016
Last Updated
August 17, 2016
Record last verified: 2016-07
Data Sharing
- IPD Sharing
- Will not share