Small Renal Mass, Kidney CancerNCT02204800
Active Surveillance of the Small Renal Mass
An observational study of Small Renal Mass, Kidney Cancer, run by Yale University at 1 site in United States.
Trial summary
Active surveillance in kidney cancer involves closely observing the tumor with periodic imaging studies rather than immediately proceeding to an invasive treatment. This does not mean that the tumor is ignored or that future treatment is not necessary, rather it means the tumor does not require treatment at this time. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Renal Mass, Kidney Cancer
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to 31 Aug 2020
- Phase
- Observational
- 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
Study population: This is a trial of active surveillance in patients with a solitary, small (1.0-2.7 cm) renal mass.
Who may be able to join
- Age ≥ 18 years
- Life expectancy >3 years (by physician estimate)
- Measurable, solid renal neoplasm, 1.0 -2.7 cm in size and visible on ultrasound
- Clear cell renal cell carcinoma histology
- Renal tumor diagnosed within 6 months
- Recent biopsy (<6 weeks) performed, if performed at an outside institution, there must be sufficient material for biomarker analysis
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- No evidence of vascular invasion or regional nodal/distant disease
- Renal tumor that is able to be managed with upfront surgery
- Adequate organ function (Hemoglobin > 9, Absolute neutrophil count (ANC) ≥ 1500/μL Platelets ≥ 100,000/μL, AST and ALT ≤3.0 upper limit of normal (ULN), total bilirubin ≤ ULN, eGFR ≥ 30
- Good Performance status (ECOG ≤2)
- Understanding and willingness to provide consent
Who cannot join
- History of a hereditary renal cancer syndrome
- Tumor >2.7 cm, stages T1b-T4
- Life expectancy <3 years
- Presence of an active, untreated, metastatic non-renal malignancy
- Uncontrolled medical illness including infections, hypertension, arrhythmias, heart failure, or myocardial infarction within 6 months that would predispose to immediate surgical therapy
- Medical contraindication to upfront surgical management of renal mass
- History of bleeding diathesis or recent bleeding episode that would prevent surgical resection
- Unwillingness to undergo monitoring and imaging studies
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale New Haven Hospital Smilow Cancer Center
New Haven, Connecticut, 06510
About this study
Official title: Active Surveillance of the Small Renal Mass: An Integrated Biomarker Trial
Active surveillance in kidney cancer involves closely observing the tumor with periodic imaging studies rather than immediately proceeding to an invasive treatment. This does not mean that the tumor is ignored or that future treatment is not necessary, rather it means the tumor does not require treatment at this time. On active surveillance, a tumor is closely monitored without treatment, however if the tumor changes and reaches a predefined threshold that your physician no longer considers safe, your physician will strongly encourage treatment.
Read the detailed description
While some patients with small kidney tumors may require eventual treatment, most do not. Therefore, the American Urologic Association considers active surveillance an acceptable treatment strategy. This protocol is a prospective study of active surveillance for small clear cell kidney tumors (the most common type of kidney tumor) and is designed to identify if there are predictive markers that may help identify which patients are unlikely to require surgical treatment. Predictive markers are measurable characteristics that may predict the future behavior of a tumor. There are currently no available predictive markers that can help identify which tumors are not destined to require treatment. Such a marker may be useful to increase the use of active surveillance by informing patients with small renal tumors that immediate treatment may be considered overtreatment.
- Conditions
- Small Renal Mass, Kidney Cancer
- Keywords
- Tumor growth rate in maximal dimension, biomarker assessment based on driver gene alterations (specifically CRG)
- Medical subject headings
- Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Small clear cell renal tumors (Wild Type) | No specific chromatin remodeling gene (CRG) alteration | |
| Small clear cell renal tumors (Mutant) | Specific chromatin remodeling gene (CRG) alteration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor growth rate
Tumor growth rate is being measured in centimeters/year
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2014 (estimated)
- Study startDec 2014
- Primary completion31 Aug 2020
- Study completion31 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Renal Mass, Kidney CancerStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brian Shuch, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02204800
- Sponsor's protocol ID
- 1312013110
- Other IDs
- Yale Department of Urology
- Status last verified
- Feb 2021
- First submitted
- 28 Jul 2014
- Last updated
- 1 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Active Surveillance of the Small Renal Mass: An Integrated Biomarker Trial
- ClinicalTrials.gov ID
- NCT02204800
- Acronym / sponsor ID
- 1312013110
- Conditions
- Small Renal Mass, Kidney Cancer
- Keywords
- Tumor growth rate in maximal dimension, biomarker assessment based on driver gene alterations (specifically CRG)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- Dec 2014 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 30 Jul 2014 (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.
Active surveillance in kidney cancer involves closely observing the tumor with periodic imaging studies rather than immediately proceeding to an invasive treatment. This does not mean that the tumor is ignored or that future treatment is not necessary, rather it means the tumor does not require treatment at this time. On active surveillance, a tumor is closely monitored without treatment, however if the tumor changes and reaches a predefined threshold that your physician no longer considers safe, your physician will strongly encourage treatment.
Detailed description
While some patients with small kidney tumors may require eventual treatment, most do not. Therefore, the American Urologic Association considers active surveillance an acceptable treatment strategy. This protocol is a prospective study of active surveillance for small clear cell kidney tumors (the most common type of kidney tumor) and is designed to identify if there are predictive markers that may help identify which patients are unlikely to require surgical treatment. Predictive markers are measurable characteristics that may predict the future behavior of a tumor. There are currently no available predictive markers that can help identify which tumors are not destined to require treatment. Such a marker may be useful to increase the use of active surveillance by informing patients with small renal tumors that immediate treatment may be considered overtreatment.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Small clear cell renal tumors (Wild Type) | – | –No specific chromatin remodeling gene (CRG) alteration |
| Small clear cell renal tumors (Mutant) | – | –Specific chromatin remodeling gene (CRG) alteration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is a trial of active surveillance in patients with a solitary, small (1.0-2.7 cm) renal mass.
Key inclusion criteria (11 listed)
- Age ≥ 18 years
- Life expectancy >3 years (by physician estimate)
- Measurable, solid renal neoplasm, 1.0 -2.7 cm in size and visible on ultrasound
- Clear cell renal cell carcinoma histology
- Renal tumor diagnosed within 6 months
Key exclusion criteria (8 listed)
- History of a hereditary renal cancer syndrome
- Tumor >2.7 cm, stages T1b-T4
- Life expectancy <3 years
- Presence of an active, untreated, metastatic non-renal malignancy
- Uncontrolled medical illness including infections, hypertension, arrhythmias, heart failure, or myocardial infarction within 6 months that would predispose to immediate surgical therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Tumor growth rate
Time frame: 36 months
Tumor growth rate is being measured in centimeters/year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2021.
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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.
Brian Shuch, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Small Renal Mass, Kidney Cancer, run by Yale University at 1 site in United States.
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 11 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: finished, as of the sponsor's last update on 1 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Tumor growth rate (time frame: 36 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 1 Mar 2021.