Renal CancerVAPANCRNCT03218319
Study of the Variations of the Blood Pressure After Nephrectomy for Renal Cancer (VAPANCR)
A study testing Renin measurement in people with Renal Cancer and Nephrectomy, run by University Hospital, Angers.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cancer, Nephrectomy, Blood Pressure
- What is being tested?
- Renin measurement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Jul 2017to Dec 2018
- Phase
- Interventional
- 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
Who may be able to join
- Nephrectomy programmed for located renal cancer
Who cannot join
- Patients with metastatic renal cancer
- Incapacity to use a self-measurement tensiometer
- Patients treated for high blood pressure
- Patients with laxative
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
- Conditions
- Renal Cancer, Nephrectomy, Blood Pressure
- Being tested
- Renin measurement
- Medical subject headings
- Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renin measurementBiological
patients will have a blood sample for measuring renin activity
| Study group | Role | What they receive |
|---|---|---|
| All patients | Experimental | Not described Receives: Biological: Renin measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure change
preoperative and postoperative measurements of blood pressure
Measured: One time before the operation and twice after : 1 month and 6 months
Secondary outcomes (2)
Renal function
preoperative and postoperative measurements of renal function with measurements of renin activity and the glomerular filtration rate.
Measured: One time before the operation and one after 6 months
Cardiovascular risk
Study the occurence of cardiovascular risk after nephrectomy
Measured: A clinical exam will perform before the surgery and 1 month and 6 months after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2017
- Study startJul 2017 (estimated)
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03218319
- Sponsor's protocol ID
- 49RC17_0004
- Acronym
- VAPANCR
- Status last verified
- Jul 2017
- First submitted
- 11 Jul 2017
- Last updated
- 14 Jul 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Variations of the Blood Pressure After Nephrectomy for Renal Cancer
- ClinicalTrials.gov ID
- NCT03218319
- Acronym / sponsor ID
- VAPANCR / 49RC17_0004
- Conditions
- Renal Cancer, Nephrectomy, Blood Pressure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- Jul 2017 (estimated)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 14 Jul 2017 (actual)
- 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.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients | Experimental | Biological: Renin measurement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Nephrectomy programmed for located renal cancer
Key exclusion criteria (4 listed)
- Patients with metastatic renal cancer
- Incapacity to use a self-measurement tensiometer
- Patients treated for high blood pressure
- Patients with laxative
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Renin measurementpatients will have a blood sample for measuring renin activity | Biological | All patients |
Primary outcome
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
2 secondary outcomes
Renal function
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2017.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Renin measurement in people with Renal Cancer and Nephrectomy, run by University Hospital, Angers.
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 1 inclusion and 4 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 14 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
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 Pierre Bigot (+332 41 35 64 94, PiBigot@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure change (time frame: One time before the operation and twice after : 1 month and 6 months). 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 14 Jul 2017.