Small Renal MassGRADE-SRMNCT03819569
GRADE-SRM: Genomic Risk Assessment and Decisional Evaluation for Small Renal Masses
A study testing Small Renal Mass Biopsy and No Small Renal Mass Biopsy in people with Small Renal Mass and Kidney Tumor, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial summary
Purpose: The purpose of this study is to evaluate the role of renal mass biopsy on decision-making for patients presenting with clinical T1 kidney tumors. This study also incorporates integrated biomarker study to compare the genomic data obtained through biopsy tissue to genomic information from surgical data. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Small Renal Mass, Kidney Tumor
- What is being tested?
- Small Renal Mass Biopsy and No Small Renal Mass Biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 265 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Oct 2018to 18 Apr 2024
- 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 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages 18 - 95
- Have a small renal mass ≤7 cm on cross-sectional radiologic study evaluated at the University of North Carolina (UNC) Urology or the UNC Cancer Hospital.
- Has voluntarily provided signed informed consent to participate and HIPAA authorization for the release of personal health information
- Willing and able to complete patient-reported outcome questionnaires
- Willing to have extra cores taken for research during the standard-of-care biopsy procedure
- Willing to allow surgical specimens to be used for research
- Willing to undergo a blood draw to evaluate for circulating tumor DNA
Who cannot join
- Has staging information indicating locally advanced or metastatic disease.
- Presence of transplant kidney
- Unwilling or unable to complete informed consent
- Previous biopsy of small renal mass.
Trial locations and contacts
1 site in 1 country.
United States1 site
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599
About this study
Purpose: The purpose of this study is to evaluate the role of renal mass biopsy on decision-making for patients presenting with clinical T1 kidney tumors. This study also incorporates integrated biomarker study to compare the genomic data obtained through biopsy tissue to genomic information from surgical data.
Read the detailed description
Primary Objective
- To compare the decisional conflict between patients who undergo renal mass biopsy during their evaluation for SRMs versus those who do not.
- To validate the concordance of RNA sequencing (RNAseq) and genomic-based risk stratification molecular biomarkers between renal biopsy tissue and surgical (nephrectomy) specimen tissue.
Secondary objective
- To characterize the impact of biopsy on patient reported anxiety and uncertainty, assessment of cancer care communication, and satisfaction with cancer care.
- Conditions
- Small Renal Mass, Kidney Tumor
- Being tested
- Small Renal Mass Biopsy, No Small Renal Mass Biopsy
- Keywords
- genomic risk assessment, small renal mass
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Small Renal Mass BiopsyProcedure or surgery
Subjects will receive a small renal mass biopsy prior to making a treatment decision
No Small Renal Mass BiopsyOther
Subjects will not receive a small renal mass biopsy prior to making a treatment decision
| Study group | Role | What they receive |
|---|---|---|
| Biopsy | Active comparator | Subjects receive a renal cell biopsy prior to making a decision about treatment Receives: Procedure: Small Renal Mass Biopsy |
| No Biopsy | Sham comparator | Subjects do not receive a renal cell biopsy prior to making a decision about treatment Receives: Other: No Small Renal Mass Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Decisional Conflict
Decisional conflict scale between patients who undergo renal mass biopsy, and who do not will be compared. Decisional conflict scale is a validated, 16-item instrument that measures personal perceptions of decision-making. It yields a total score from 0 to 100 (higher scores indicate more decisional conflict) and sub-scores for perceptions of uncertainty, informed values clarity, support, and effectiveness in decision-making.
Measured: Baseline, 1-3 months (before treatment)
Receipt of nephrectomy
The proportion of patients undergoing nephrectomy (radical and partial nephrectomy) between patients who undergo renal mass biopsy versus those who do not will be compared.
Measured: 1-3 months (index treatment), 2 years
Genomic mutations comparison
Molecular subtype (ccA vs ccB) and the presence of genomic mutations between the renal mass biopsy and the surgical nephrectomy specimen will be compared.
Measured: 2 years
Secondary outcomes (8)
Patient-reported anxiety
Patient-reported anxiety will be assessed using the Short Form PROMIS Anxiety scale. Short Form PROMIS Anxiety is a validated 4-item survey of generalized anxiety, consisting of 5 questions, each scored using a 5-point Likert scale. High scores reflect better results.
Measured: Baseline, 1-3 months (before treatment), 6, 12, 18, 24 months
Patient-reported cancer worry
Patient-reported cancer worry will be assessed using the Brief Worry Scale which is a 4 questions assessment designed to measure the relationship between worry and an event or behavior. This study will use the brief worry scale to measure the relationship between worry and the diagnosis of a small renal mass.
Measured: Baseline, 1-3 months (before treatment), 6, 12, 18, 24 months
Patient-Reported Risk Perception
Patient-reported Risk Perception will be assessed using 2 two-question instrument to assign a numeric risk score for patients regarding incidental renal lesions, which may facilitate accurate risk comprehension.
Measured: Baseline, 1-3 months (before treatment)
Patient-reported uncertainty based on Short-Form Mishel Uncertainty of Illness Scale
Patient-reported uncertainty will be assessed using the Short-Form Mishel Uncertainty of Illness Scale which is a validated instrument that measures the patient's perception of the uncertainty of symptoms, diagnosis, treatment, and prognosis as well as the uncertainty subscale of the Decisional Conflict Scale. The scores are summed to yield a total score with a higher score indicating greater uncertainty.
Measured: baseline, 1-3 months (before treatment)
Patient-reported regret about the decision
Patient-reported regret about the decision will be assessed using the Decisional regret scale. Decisional Regret scale is a 5-item regret scale that measures distress or remorse after a healthcare decision. The short form consists of 5 questions, each scored using a 5-point Likert scale, indicating a number from 1 (Strongly Agree) to 5 (Strongly Disagree).
Measured: 6, 12, 18, 24 months
Patient-reported health-related quality of life
Patient-reported health-related quality of life will be assessed using The PROMIS Global Health scale is an 8-item, validated survey that represents five core PROMIS domains (physical function, pain, fatigue, emotional distress, social health). Higher score indicating better quality of life.
Measured: Baseline, 1-3 months (before treatment), 6, 12, 18, 24 months
Patient reported assessment of communication in cancer care
The validated 6-item Short-Form for Patient-Centered Communication-Cancer Scale. This is a validated, 6-item instrument that measures the patient's perspective on communication in cancer care. It incorporates questions relating to exchanging information, fostering relationships, making decisions, responding to emotions, enabling self-efficacy, and managing uncertainty. Each item is scored 1-5, and the overall score is an average of 6 questions, with 5 indicating the most satisfaction. A high score indicates better communication.
Measured: Baseline, 1-3 months (before treatment)
Receipt of any intervention (ablation, radiation therapy, nephrectomy)
The proportion of patients undergoing ablation, radiation therapy, nephrectomy between patients who undergo renal mass biopsy versus those who do not will be compared
Measured: 1-3 months (index treatment), 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2019
- Study start30 Oct 2018
- Primary completion18 Apr 2024
- Study completion18 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Small Renal MassStudies of the same condition, open and under way.
- More trials run by UNC Lineberger Comprehensive Cancer CenterThe 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- non-randomized, comparative
- Masking
- None (open label)
- Enrolment
- 265 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hung J Tan, MD, Principal investigator, UNC Lineberger Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03819569
- Sponsor's protocol ID
- LCCC 1834
- Acronym
- GRADE-SRM
- Status last verified
- Jul 2024
- First submitted
- 29 Nov 2018
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Feinberg A, Gessner KH, Deal AM, Heiling HM, Myers S, Raynor MC, Milowsky MI, Wobker SE, Commander CW, Lazard AJ, Bjurlin MA, Smith AB, Johnson DC, Wallen EM, Kim WY, Tan HJ. Decisional Conflict Among Patients Newly Diagnosed With Clinical T1 Renal Masses: A Prospective Study. J Urol. 2024 Aug;212(2):320-330. doi: 10.1097/JU.0000000000004023. Epub 2024 May 8.
PubMed 38717916
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GRADE-SRM: Genomic Risk Assessment and Decisional Evaluation for Small Renal Masses
- ClinicalTrials.gov ID
- NCT03819569
- Acronym / sponsor ID
- GRADE-SRM / LCCC 1834
- Conditions
- Small Renal Mass, Kidney Tumor
- Keywords
- genomic risk assessment, small renal mass
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 265 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 30 Oct 2018 (actual)
- Primary completion
- 18 Apr 2024 (actual)
- Study completion
- 18 Apr 2024 (actual)
- First posted
- 28 Jan 2019 (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.
Purpose: The purpose of this study is to evaluate the role of renal mass biopsy on decision-making for patients presenting with clinical T1 kidney tumors. This study also incorporates integrated biomarker study to compare the genomic data obtained through biopsy tissue to genomic information from surgical data.
Detailed description
Primary Objective
- To compare the decisional conflict between patients who undergo renal mass biopsy during their evaluation for SRMs versus those who do not.
- To validate the concordance of RNA sequencing (RNAseq) and genomic-based risk stratification molecular biomarkers between renal biopsy tissue and surgical (nephrectomy) specimen tissue.
Secondary objective
- To characterize the impact of biopsy on patient reported anxiety and uncertainty, assessment of cancer care communication, and satisfaction with cancer care.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- non-randomized, comparative
| Arm | Type | Receives |
|---|---|---|
| Biopsy | Active comparator | Procedure: Small Renal Mass BiopsySubjects receive a renal cell biopsy prior to making a decision about treatment |
| No Biopsy | Sham comparator | Other: No Small Renal Mass BiopsySubjects do not receive a renal cell biopsy prior to making a decision about treatment |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Ages 18 - 95
- Have a small renal mass ≤7 cm on cross-sectional radiologic study evaluated at the University of North Carolina (UNC) Urology or the UNC Cancer Hospital.
- Has voluntarily provided signed informed consent to participate and HIPAA authorization for the release of personal health information
- Willing and able to complete patient-reported outcome questionnaires
- Willing to have extra cores taken for research during the standard-of-care biopsy procedure
Key exclusion criteria (4 listed)
- Has staging information indicating locally advanced or metastatic disease.
- Presence of transplant kidney
- Unwilling or unable to complete informed consent
- Previous biopsy of small renal mass.
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 |
|---|---|---|
| Small Renal Mass BiopsySubjects will receive a small renal mass biopsy prior to making a treatment decision | Procedure or surgery | Biopsy |
| No Small Renal Mass BiopsySubjects will not receive a small renal mass biopsy prior to making a treatment decision | Other | No Biopsy |
Primary outcome
Change in Decisional Conflict
Time frame: Baseline, 1-3 months (before treatment)
Decisional conflict scale between patients who undergo renal mass biopsy, and who do not will be compared. Decisional conflict scale is a validated, 16-item instrument that measures personal perceptions of decision-making. It yields a total score from 0 to 100 (higher scores indicate more decisional conflict) and sub-scores for perceptions of uncertainty, informed values clarity, support, and effectiveness in decision-making.
Receipt of nephrectomy
Time frame: 1-3 months (index treatment), 2 years
The proportion of patients undergoing nephrectomy (radical and partial nephrectomy) between patients who undergo renal mass biopsy versus those who do not will be compared.
Genomic mutations comparison
Time frame: 2 years
Molecular subtype (ccA vs ccB) and the presence of genomic mutations between the renal mass biopsy and the surgical nephrectomy specimen will be compared.
8 secondary outcomes
Patient-reported anxiety
Time frame: Baseline, 1-3 months (before treatment), 6, 12, 18, 24 months
Patient-reported cancer worry
Time frame: Baseline, 1-3 months (before treatment), 6, 12, 18, 24 months
Patient-Reported Risk Perception
Time frame: Baseline, 1-3 months (before treatment)
Patient-reported uncertainty based on Short-Form Mishel Uncertainty of Illness Scale
Time frame: baseline, 1-3 months (before treatment)
Patient-reported regret about the decision
Time frame: 6, 12, 18, 24 months
Patient-reported health-related quality of life
Time frame: Baseline, 1-3 months (before treatment), 6, 12, 18, 24 months
Patient reported assessment of communication in cancer care
Time frame: Baseline, 1-3 months (before treatment)
Receipt of any intervention (ablation, radiation therapy, nephrectomy)
Time frame: 1-3 months (index treatment), 2 years
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 3 Jul 2024.
- Derived from this study: PubMed 38717916Feinberg A, Gessner KH, Deal AM, Heiling HM, Myers S, Raynor MC, Milowsky MI, Wobker SE, Commander CW, Lazard AJ, Bjurlin MA, Smith AB, Johnson DC, Wallen EM, Kim WY, Tan HJ. Decisional Conflict Among Patients Newly Diagnosed With Clinical T1 Renal Masses: A Prospective Study. J Urol. 2024 Aug;212(2):320-330. doi: 10.1097/JU.0000000000004023. Epub 2024 May 8.
- University of North Carolina Lineberger Comprehensive Cancer Center Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Hung J Tan, MD principal investigator
UNC Lineberger Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Small Renal Mass Biopsy and No Small Renal Mass Biopsy in people with Small Renal Mass and Kidney Tumor, run by UNC Lineberger Comprehensive Cancer Center 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 7 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: finished, as of the sponsor's last update on 3 Jul 2024. 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. Some participants in this study may receive a placebo. 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?
Change in Decisional Conflict (time frame: Baseline, 1-3 months (before treatment)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03819569, which also lists 1 linked publication.
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 3 Jul 2024.