NephrectomyNCT02870621
Volume of Perirenal Fat and Chronic Kidney Disease
An observational study of Nephrectomy, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nephrectomy
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2012to Sep 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU de Nice
Nice
Guilaume FAVRE, Dr, 4 92 03 88 24 ext. +33, favre.g@chu-nice.fr
Guillaume FAVRE, Dr
About this study
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.
- Conditions
- Nephrectomy
What is being measured
The primary outcome is the main question the study is designed to answer.
Numbers of renal interstitial fibrosis
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2016 (estimated)
- Study startJul 2012
- Primary completionSep 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NephrectomyStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02870621
- Sponsor's protocol ID
- 12-PP-06
- Status last verified
- Jul 2016
- First submitted
- 29 Jul 2016
- Last updated
- 17 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Volume of Perirenal Fat and Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT02870621
- Acronym / sponsor ID
- 12-PP-06
- Conditions
- Nephrectomy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Sep 2016 (estimated)
- First posted
- 17 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Numbers of renal interstitial fibrosis
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nephrectomy, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guillaume FAVRE, Dr (4 92 03 88 24 ext. +33, favre.g@chu-nice.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numbers of renal interstitial fibrosis (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2016.