Kidney NeoplasmsNCT02841020
The Effect of Pre-treatment Biopsy for Non-neoplastic Renal Disease vs no Biopsy on Estimated Glomerular Filtration Rate in Patients With Small Renal Mass: a Single-center, Single-blinded, Randomized, Parallel Group Clinical Trial
A study testing Additional biopsy in people with Kidney Neoplasms, run by University of Virginia.
Trial summary
The purpose of this study is to determine if biopsy for non-neoplastic renal disease for patients with a small renal mass results in greater postoperative renal function than the current standard of care (no additional biopsy). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Kidney Neoplasms
- What is being tested?
- Additional biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2018to Mar 2020
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 or greater
- Scheduled for renal biopsy as part of clinical care
- Diagnosis of small renal mass (< 4cm) based on imaging (CT, MRI, Ultrasound, or other)
- Patient must provide written, informed consent for study procedures before randomization
- Renal mass must be primarily solid (as opposed to cystic) in nature
Who cannot join
- Patients less than 18 years of age
- Patients who are prisoners
- Women who are pregnant-self reported
- Patients with Bosniak 3 or 4 cystic renal masses
- Patients with history of renal transplantation
- Patients with eGFR less than 30-based on review of clinical labs
- Patients on dialysis
- Patients with bleeding disorders
About this study
The purpose of this study is to determine if biopsy for non-neoplastic renal disease for patients with a small renal mass results in greater postoperative renal function than the current standard of care (no additional biopsy).
- Conditions
- Kidney Neoplasms
- Being tested
- Additional biopsy
- Medical subject headings
- Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Additional biopsyProcedure or surgery
- Patients in the experimental group receive the additional biopsy for non-neoplastic disease during the same procedure before the biopsy of the renal mass (with potential for direct benefit to the patient by revealing non-neoplastic renal disease).
| Study group | Role | What they receive |
|---|---|---|
| Control SOC | No intervention | Standard of care is followed |
| Experimental additional biopsy | Experimental | Additional biopsy Receives: Procedure: Additional biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
difference in change in glomerular filtration rate (GFR)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2016 (estimated)
- Study startJun 2018 (estimated)
- Primary completionDec 2019 (estimated)
- Study completionMar 2020 (estimated)
Why it stopped: Funding for study fell through
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney NeoplasmsStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noah Schenkman, MD, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02841020
- Sponsor's protocol ID
- 19081
- Status last verified
- Nov 2017
- First submitted
- 19 Jul 2016
- Last updated
- 30 Oct 2018
- 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 30 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pre-treatment Biopsy for Non-neoplastic Renal Disease vs no Biopsy on Estimated Glomerular Filtration Rate in Patients With Small Renal Mass: a Single-center, Single-blinded, Randomized, Parallel Group Clinical Trial
- ClinicalTrials.gov ID
- NCT02841020
- Acronym / sponsor ID
- 19081
- Conditions
- Kidney Neoplasms
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding for study fell through
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- Jun 2018 (estimated)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Mar 2020 (estimated)
- First posted
- 21 Jul 2016 (estimated)
- 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.
The purpose of this study is to determine if biopsy for non-neoplastic renal disease for patients with a small renal mass results in greater postoperative renal function than the current standard of care (no additional biopsy).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control SOC | No intervention | –Standard of care is followed |
| Experimental additional biopsy | Experimental | Procedure: Additional biopsyAdditional biopsy |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 or greater
- Scheduled for renal biopsy as part of clinical care
- Diagnosis of small renal mass (< 4cm) based on imaging (CT, MRI, Ultrasound, or other)
- Patient must provide written, informed consent for study procedures before randomization
- Renal mass must be primarily solid (as opposed to cystic) in nature
Key exclusion criteria (8 listed)
- Patients less than 18 years of age
- Patients who are prisoners
- Women who are pregnant-self reported
- Patients with Bosniak 3 or 4 cystic renal masses
- Patients with history of renal transplantation
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 |
|---|---|---|
| Additional biopsy• Patients in the experimental group receive the additional biopsy for non-neoplastic disease during the same procedure before the biopsy of the renal mass (with potential for direct benefit to the patient by revealing non-neoplastic renal disease). | Procedure or surgery | Experimental additional biopsy |
Primary outcome
difference in change in glomerular filtration rate (GFR)
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Additional biopsy in people with Kidney Neoplasms, run by University of Virginia.
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 5 inclusion and 8 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: withdrawn, as of the sponsor's last update on 30 Oct 2018. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
difference in change in glomerular filtration rate (GFR) (time frame: 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 30 Oct 2018.