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GRADE-SRM: Genomic Risk Assessment and Decisional Evaluation for Small Renal Masses (GRADE-SRM)

Primary Purpose

Small Renal Mass, Kidney Tumor

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Small Renal Mass Biopsy
No Small Renal Mass Biopsy
Sponsored by
UNC Lineberger Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Small Renal Mass focused on measuring genomic risk assessment, small renal mass

Eligibility Criteria

18 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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 release of personal health information
  • Willing and able to complete patient-reported outcome questionnaires
  • Willing to have extra cores taken for research during 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

Exclusion Criteria

  • Has staging information indicating locally advanced or metastatic disease.
  • Presence of transplant kidney
  • Unwilling or unable to complete informed consent

Sites / Locations

  • UNC Lineberger Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Biopsy

No Biopsy

Arm Description

Subjects receive a renal cell biopsy prior to making a decision about treatment

Subjects do not receive a renal cell biopsy prior to making a decision about treatment

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
Patient-reported uncertainty
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.
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).
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.
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.
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

Full Information

First Posted
November 29, 2018
Last Updated
October 18, 2023
Sponsor
UNC Lineberger Comprehensive Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT03819569
Brief Title
GRADE-SRM: Genomic Risk Assessment and Decisional Evaluation for Small Renal Masses
Acronym
GRADE-SRM
Official Title
GRADE-SRM: Genomic Risk Assessment and Decisional Evaluation for Small Renal Masses
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 30, 2018 (Actual)
Primary Completion Date
December 30, 2024 (Anticipated)
Study Completion Date
December 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UNC Lineberger Comprehensive Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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 1. To characterize the impact of biopsy on patient reported anxiety and uncertainty, assessment of cancer care communication, and satisfaction with cancer care.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small Renal Mass, Kidney Tumor
Keywords
genomic risk assessment, small renal mass

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
non-randomized, comparative
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
265 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Biopsy
Arm Type
Active Comparator
Arm Description
Subjects receive a renal cell biopsy prior to making a decision about treatment
Arm Title
No Biopsy
Arm Type
Sham Comparator
Arm Description
Subjects do not receive a renal cell biopsy prior to making a decision about treatment
Intervention Type
Procedure
Intervention Name(s)
Small Renal Mass Biopsy
Intervention Description
Subjects will receive a small renal mass biopsy prior to making a treatment decision
Intervention Type
Other
Intervention Name(s)
No Small Renal Mass Biopsy
Intervention Description
Subjects will not receive a small renal mass biopsy prior to making a treatment decision
Primary Outcome Measure Information:
Title
Change in Decisional Conflict
Description
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.
Time Frame
Baseline, 1-3 months (before treatment)
Title
Receipt of nephrectomy
Description
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.
Time Frame
1-3 months (index treatment), 2 years
Title
Genomic mutations comparison
Description
Molecular subtype (ccA vs ccB) and the presence of genomic mutations between the renal mass biopsy and the surgical nephrectomy specimen will be compared.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Patient-reported anxiety
Description
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.
Time Frame
Baseline, 1-3 months (before treatment), 6, 12, 18, 24 months
Title
Patient-reported cancer worry
Description
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.
Time Frame
Baseline, 1-3 months (before treatment), 6, 12, 18, 24 months
Title
Patient-Reported Risk Perception
Description
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.
Time Frame
Baseline, 1-3 months (before treatment)
Title
Patient-reported uncertainty
Description
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.
Time Frame
baseline, 1-3 months (before treatment)
Title
Patient-reported regret about the decision
Description
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).
Time Frame
6, 12, 18, 24 months
Title
Patient-reported health-related quality of life
Description
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.
Time Frame
Baseline, 1-3 months (before treatment), 6, 12, 18, 24 months
Title
Patient reported assessment of communication in cancer care
Description
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.
Time Frame
Baseline, 1-3 months (before treatment)
Title
Receipt of any intervention (ablation, radiation therapy, nephrectomy)
Description
The proportion of patients undergoing ablation, radiation therapy, nephrectomy between patients who undergo renal mass biopsy versus those who do not will be compared
Time Frame
1-3 months (index treatment), 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hung J Tan, MD
Organizational Affiliation
UNC Lineberger Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
UNC Lineberger Comprehensive Cancer Center
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://unclineberger.org/patientcare/clinical-trials/clinical-trials
Description
University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials

Learn more about this trial

GRADE-SRM: Genomic Risk Assessment and Decisional Evaluation for Small Renal Masses

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