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

Republished By Plato

October 29, 2018

Studies

Study First Submitted Date	2018-11-29
Study First Posted Date	2019-01-28
Last Update Posted Date	2023-03-24
Start Month Year	October 30, 2018
Primary Completion Month Year	December 30, 2024
Verification Month Year	March 2023
Verification Date	2023-03-31
Last Update Posted Date	2023-03-24

Detailed Descriptions

Sequence:

20768997

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.

Facilities

Sequence:	200496836
Name	UNC Lineberger Comprehensive Cancer Center
City	Chapel Hill
State	North Carolina
Zip	27599
Country	United States

Conditions

Sequence:	52292876	Sequence:	52292877
Name	Small Renal Mass	Name	Kidney Tumor
Downcase Name	small renal mass	Downcase Name	kidney tumor

Id Information

Sequence:	40246201
Id Source	org_study_id
Id Value	LCCC 1834

Countries

Sequence:	42663896
Name	United States
Removed	False

Design Groups

Sequence:	55728818	Sequence:	55728819
Group Type	Active Comparator	Group Type	Sham Comparator
Title	Biopsy	Title	No Biopsy
Description	Subjects receive a renal cell biopsy prior to making a decision about treatment	Description	Subjects do not receive a renal cell biopsy prior to making a decision about treatment

Interventions

Sequence:	52604498	Sequence:	52604499
Intervention Type	Procedure	Intervention Type	Other
Name	Small Renal Mass Biopsy	Name	No Small Renal Mass Biopsy
Description	Subjects will receive a small renal mass biopsy prior to making a treatment decision	Description	Subjects will not receive a small renal mass biopsy prior to making a treatment decision

Keywords

Sequence:	80039935	Sequence:	80039936
Name	genomic risk assessment	Name	small renal mass
Downcase Name	genomic risk assessment	Downcase Name	small renal mass

Design Outcomes

Sequence:	177826314	Sequence:	177826315	Sequence:	177826316	Sequence:	177826317	Sequence:	177826318
Outcome Type	primary	Outcome Type	primary	Outcome Type	secondary	Outcome Type	secondary	Outcome Type	secondary
Measure	Change in decisional conflict score	Measure	The concordance of Molecular subtype generated from Clearcode 34 gene set on biopsy tissue compared to nephrectomy samples	Measure	Patient-reported anxiety	Measure	Patient-reported assessment of communication in cancer care	Measure	Patient-reported satisfaction with cancer care
Time Frame	3 years	Time Frame	5 years	Time Frame	3 years	Time Frame	3 years	Time Frame	3 years
Description	The validated 16-item Decisional conflict scale (0 to 100) will be measured before and after biopsy. Higher scores indicate more decisional conflict, scores below 25 indicate low decisional conflict	Description	Molecular Subtype generated from ClearCode 34 gene set	Description	The validated, 14-item hospital anxiety and depression scale (0-21). Higher scores indicate more depression and anxiety	Description	The validated, 6-item short-form for patient-centered communication-cancer scale. Each item is scored 1-5, and the overall score is an average of 6 questions, with 5 indicating the most satisfaction	Description	The 16-item validated Service Satisfaction Scale for Cancer Care (0-100). A higher score indicated higher satisfaction with cancer care.

Browse Conditions

Sequence:

193951144

Sequence:

193951145

Sequence:

193951146

Sequence:

193951147

Sequence:

193951148

Sequence:

193951149

Sequence:

193951150

Sequence:

193951151

Sequence:

193951152

Sequence:

193951142

Sequence:

193951143

Mesh Term

Urogenital Neoplasms

Mesh Term

Neoplasms by Site

Mesh Term

Neoplasms

Mesh Term

Female Urogenital Diseases

Mesh Term

Female Urogenital Diseases and Pregnancy Complications

Mesh Term

Urogenital Diseases

Mesh Term

Kidney Diseases

Mesh Term

Urologic Diseases

Mesh Term

Male Urogenital Diseases

Mesh Term

Kidney Neoplasms

Mesh Term

Urologic Neoplasms

Downcase Mesh Term

urogenital neoplasms

Downcase Mesh Term

neoplasms by site

Downcase Mesh Term

neoplasms

Downcase Mesh Term

female urogenital diseases

Downcase Mesh Term

female urogenital diseases and pregnancy complications

Downcase Mesh Term

urogenital diseases

Downcase Mesh Term

kidney diseases

Downcase Mesh Term

urologic diseases

Downcase Mesh Term

male urogenital diseases

Downcase Mesh Term

kidney neoplasms

Downcase Mesh Term

urologic neoplasms

Mesh Type

mesh-ancestor

Mesh Type

mesh-ancestor

Mesh Type

mesh-ancestor

Mesh Type

mesh-ancestor

Mesh Type

mesh-ancestor

Mesh Type

mesh-ancestor

Mesh Type

mesh-ancestor

Mesh Type

mesh-ancestor

Mesh Type

mesh-ancestor

Mesh Type

mesh-list

Mesh Type

mesh-ancestor

Overall Officials

Sequence:	29350804
Role	Principal Investigator
Name	Hung J Tan, MD
Affiliation	UNC Lineberger Comprehensive Cancer Center

Design Group Interventions

Sequence:	68312711	Sequence:	68312712
Design Group Id	55728818	Design Group Id	55728819
Intervention Id	52604498	Intervention Id	52604499

Eligibilities

Sequence:	30836015
Gender	All
Minimum Age	18 Years
Maximum Age	95 Years
Healthy Volunteers	No
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 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
Adult	True
Child	False
Older Adult	True

Calculated Values

Sequence:	254155425
Number Of Facilities	1
Registered In Calendar Year	2018
Were Results Reported	False
Has Us Facility	True
Has Single Facility	True
Minimum Age Num	18
Maximum Age Num	95
Minimum Age Unit	Years
Maximum Age Unit	Years
Number Of Primary Outcomes To Measure	2
Number Of Secondary Outcomes To Measure	3

Designs

Sequence:	30581919
Allocation	Non-Randomized
Intervention Model	Parallel Assignment
Observational Model
Primary Purpose	Other
Time Perspective
Masking	None (Open Label)
Intervention Model Description	non-randomized, comparative

Responsible Parties

Sequence:	28948349
Responsible Party Type	Sponsor

Sequence:	48433291
Agency Class	OTHER
Lead Or Collaborator	lead
Name	UNC Lineberger Comprehensive Cancer Center