- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03218319
Study of the Variations of the Blood Pressure After Nephrectomy for Renal Cancer (VAPANCR) (VAPANCR)
July 12, 2017 updated by: University Hospital, Angers
Study of the Variations of the Blood Pressure After Nephrectomy for Renal Cancer
This study evaluates the impact of nephrectomy in renal cancer on blood pressure and renal function.
The patients will have a follow-up of their blood pressure and renal function until 6 months after their operation.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Nephrectomy programmed for located renal cancer
Exclusion Criteria:
- Patients with metastatic renal cancer
- Incapacity to use a self-measurement tensiometer
- Patients treated for high blood pressure
- Patients with laxative
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: All patients
|
patients will have a blood sample for measuring renin activity
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Blood pressure change
Time Frame: One time before the operation and twice after : 1 month and 6 months
|
preoperative and postoperative measurements of blood pressure
|
One time before the operation and twice after : 1 month and 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Renal function
Time Frame: One time before the operation and one after 6 months
|
preoperative and postoperative measurements of renal function with measurements of renin activity and the glomerular filtration rate.
|
One time before the operation and one after 6 months
|
|
Cardiovascular risk
Time Frame: A clinical exam will perform before the surgery and 1 month and 6 months after
|
Study the occurence of cardiovascular risk after nephrectomy
|
A clinical exam will perform before the surgery and 1 month and 6 months after
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
July 1, 2017
Primary Completion (ANTICIPATED)
December 1, 2018
Study Completion (ANTICIPATED)
December 1, 2018
Study Registration Dates
First Submitted
July 11, 2017
First Submitted That Met QC Criteria
July 12, 2017
First Posted (ACTUAL)
July 14, 2017
Study Record Updates
Last Update Posted (ACTUAL)
July 14, 2017
Last Update Submitted That Met QC Criteria
July 12, 2017
Last Verified
July 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 49RC17_0004
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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