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Study of the Variations of the Blood Pressure After Nephrectomy for Renal Cancer (VAPANCR) (VAPANCR)

Primary Purpose

Renal Cancer, Nephrectomy, Blood Pressure

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Renin measurement
Sponsored by
University Hospital, Angers
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Renal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    All patients

    Arm Description

    Outcomes

    Primary Outcome Measures

    Blood pressure change
    preoperative and postoperative measurements of blood pressure

    Secondary Outcome Measures

    Renal function
    preoperative and postoperative measurements of renal function with measurements of renin activity and the glomerular filtration rate.
    Cardiovascular risk
    Study the occurence of cardiovascular risk after nephrectomy

    Full Information

    First Posted
    July 11, 2017
    Last Updated
    July 12, 2017
    Sponsor
    University Hospital, Angers
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03218319
    Brief Title
    Study of the Variations of the Blood Pressure After Nephrectomy for Renal Cancer (VAPANCR)
    Acronym
    VAPANCR
    Official Title
    Study of the Variations of the Blood Pressure After Nephrectomy for Renal Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    July 2017 (Anticipated)
    Primary Completion Date
    December 2018 (Anticipated)
    Study Completion Date
    December 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Hospital, Angers

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Renal Cancer, Nephrectomy, Blood Pressure

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    All patients
    Arm Type
    Experimental
    Intervention Type
    Biological
    Intervention Name(s)
    Renin measurement
    Intervention Description
    patients will have a blood sample for measuring renin activity
    Primary Outcome Measure Information:
    Title
    Blood pressure change
    Description
    preoperative and postoperative measurements of blood pressure
    Time Frame
    One time before the operation and twice after : 1 month and 6 months
    Secondary Outcome Measure Information:
    Title
    Renal function
    Description
    preoperative and postoperative measurements of renal function with measurements of renin activity and the glomerular filtration rate.
    Time Frame
    One time before the operation and one after 6 months
    Title
    Cardiovascular risk
    Description
    Study the occurence of cardiovascular risk after nephrectomy
    Time Frame
    A clinical exam will perform before the surgery and 1 month and 6 months after

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Pierre Bigot
    Phone
    +332 41 35 64 94
    Email
    PiBigot@chu-angers.fr

    12. IPD Sharing Statement

    Learn more about this trial

    Study of the Variations of the Blood Pressure After Nephrectomy for Renal Cancer (VAPANCR)

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