NCT03218319

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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2017

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2017

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

July 11, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 14, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

July 14, 2017

Status Verified

July 1, 2017

Enrollment Period

1.4 years

First QC Date

July 11, 2017

Last Update Submit

July 12, 2017

Conditions

Renal CancerNephrectomyBlood Pressure

Outcome Measures

Primary Outcomes (1)

  • 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 (2)

  • Renal function

    One time before the operation and one after 6 months

  • Cardiovascular risk

    A clinical exam will perform before the surgery and 1 month and 6 months after

Study Arms (1)

All patients

EXPERIMENTAL
Biological: Renin measurement

Interventions

Renin measurementBIOLOGICAL

patients will have a blood sample for measuring renin activity

All patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Nephrectomy programmed for located renal cancer

You may not qualify if:

  • Patients with metastatic renal cancer
  • Incapacity to use a self-measurement tensiometer
  • Patients treated for high blood pressure
  • Patients with laxative

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Kidney Neoplasms

Interventions

Renin

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Aspartic Acid EndopeptidasesAspartic Acid ProteasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesEndopeptidasesProprotein Convertases

Central Study Contacts

Pierre Bigot

CONTACT

+332 41 35 64 94PiBigot@chu-angers.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2017

First Posted

July 14, 2017

Study Start

July 1, 2017

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

July 14, 2017

Record last verified: 2017-07