Study of the Variations of the Blood Pressure After Nephr... | NCT03218319

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

NCT03218319

Sponsor

University Hospital, Angers

Status

Unknown status

Last Update Posted

Jul 14, 2017Actual

Enrollment

200Estimated

Phase

Not Applicable

Conditions

Renal Cancer
Nephrectomy
Blood Pressure

Interventions

Renin measurement

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2017Estimated

Primary Completion Date

Dec 2018Estimated

Completion Date

Dec 2018Estimated

First Submitted Date

Jul 11, 2017

First Submission Date that Met QC Criteria

Jul 12, 2017

First Posted Date

Jul 14, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 12, 2017

Last Update Posted Date

Jul 14, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
All patients	Experimental		Biological: Renin measurement

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Renin measurement	Biological	patients will have a blood sample for measuring renin activity	All patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Blood pressure change	preoperative and postoperative measurements of blood pressure	One time before the operation and twice after : 1 month and 6 months

Secondary Outcomes

Measure	Description	Time Frame
Renal function	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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Pierre Bigot	Contact	+332 41 35 64 94		PiBigot@chu-angers.fr

Overall Officials

Not provided

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007680	Kidney Neoplasms

Ancestor Terms

ID	Term
D014571	Urologic Neoplasms
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D012083	Renin

Ancestor Terms

ID	Term
D016282	Aspartic Acid Endopeptidases
D057055	Aspartic Acid Proteases
D010447	Peptide Hydrolases
D006867	Hydrolases

Browse Leaves

Not provided

Browse Branches

Not provided