NCT02870621

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

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

July 29, 2016

Completed
19 days until next milestone

First Posted

Study publicly available on registry

August 17, 2016

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Last Updated

August 17, 2016

Status Verified

July 1, 2016

Enrollment Period

4.2 years

First QC Date

July 29, 2016

Last Update Submit

August 12, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Numbers of renal interstitial fibrosis

    1 day

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

RECRUITING

Central Study Contacts

Guillaume FAVRE, Dr

CONTACT

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

Locations