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Trial record 67 of 2224 for:    Recruiting, Not yet recruiting, Available Studies | Renal

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

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ClinicalTrials.gov Identifier: NCT03819569
Recruitment Status : Recruiting
First Posted : January 28, 2019
Last Update Posted : January 28, 2019
Sponsor:
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center

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.

Condition or disease Intervention/treatment Phase
Small Renal Mass Kidney Tumor Procedure: Small Renal Mass Biopsy Other: No Small Renal Mass Biopsy Not Applicable

Detailed Description:

Primary Objective

  1. To compare the decisional conflict between patients who undergo renal mass biopsy during their evaluation for SRMs versus those who do not.
  2. 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: non-randomized, comparative
Masking: None (Open Label)
Primary Purpose: Other
Official Title: GRADE-SRM: Genomic Risk Assessment and Decisional Evaluation for Small Renal Masses
Actual Study Start Date : October 30, 2018
Estimated Primary Completion Date : March 30, 2021
Estimated Study Completion Date : December 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arm Intervention/treatment
Active Comparator: Biopsy
Subjects receive a renal cell biopsy prior to making a decision about treatment
Procedure: Small Renal Mass Biopsy
Subjects will receive a small renal mass biopsy prior to making a treatment decision

Sham Comparator: No Biopsy
Subjects do not receive a renal cell biopsy prior to making a decision about treatment
Other: No Small Renal Mass Biopsy
Subjects will not receive a small renal mass biopsy prior to making a treatment decision




Primary Outcome Measures :
  1. Change in decisional conflict score [ Time Frame: 3 years ]
    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

  2. The concordance of Molecular subtype generated from Clearcode 34 gene set on biopsy tissue compared to nephrectomy samples [ Time Frame: 5 years ]
    Molecular Subtype generated from ClearCode 34 gene set


Secondary Outcome Measures :
  1. Patient-reported anxiety [ Time Frame: 3 years ]
    The validated, 14-item hospital anxiety and depression scale (0-21). Higher scores indicate more depression and anxiety

  2. Patient-reported assessment of communication in cancer care [ Time Frame: 3 years ]
    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

  3. Patient-reported satisfaction with cancer care [ Time Frame: 3 years ]
    The 16-item validated Service Satisfaction Scale for Cancer Care (0-100). A higher score indicated higher satisfaction with cancer care.



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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03819569


Contacts
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Contact: Shannon L Myers 919-966-6604 shannon_myers@med.unc.edu
Contact: Kathryn M Pietrosimone, PhD 919-445-6375 kp@med.unc.edu

Locations
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United States, North Carolina
UNC Lineberger Comprehensive Cancer Center Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Kathryn M Pietrosimone, PhD    919-445-6375    kp@med.unc.edu   
Contact: Shannon L Myers    9199666604    shannon_myers@med.unc.edu   
Principal Investigator: Hung-Jui Tan, MD, MSHPM         
Sponsors and Collaborators
UNC Lineberger Comprehensive Cancer Center

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Responsible Party: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT03819569     History of Changes
Other Study ID Numbers: LCCC 1834
First Posted: January 28, 2019    Key Record Dates
Last Update Posted: January 28, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by UNC Lineberger Comprehensive Cancer Center:
genomic risk assessment
small renal mass
Additional relevant MeSH terms:
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Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Kidney Diseases
Urologic Diseases