GRADE-SRM: Genomic Risk Assessment and Decisional Evaluation for Small Renal Masses
NCT ID: NCT03819569
Last Updated: 2024-07-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
265 participants
INTERVENTIONAL
2018-10-30
2024-04-18
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Non-Invasive Diagnostics of Small Renal Masses
NCT03667885
Studying Genes in Samples From Younger Patients With Rhabdomyosarcoma
NCT01585376
Glycosaminoglycan Scores as Monitoring Biomarkers in Confined Renal Cell Carcinoma
NCT02732652
Genetic Evaluation of Renal Cell Carcinoma; Predicting Biomarkers for Renal Cell Carcinoma
NCT03414827
Studying Biomarkers in Samples From Young Patients With Rhabdoid Tumors
NCT01544569
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Biopsy
Subjects receive a renal cell biopsy prior to making a decision about treatment
Small Renal Mass Biopsy
Subjects will receive a small renal mass biopsy prior to making a treatment decision
No Biopsy
Subjects do not receive a renal cell biopsy prior to making a decision about treatment
No Small Renal Mass Biopsy
Subjects will not receive a small renal mass biopsy prior to making a treatment decision
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Small Renal Mass Biopsy
Subjects will receive a small renal mass biopsy prior to making a treatment decision
No Small Renal Mass Biopsy
Subjects will not receive a small renal mass biopsy prior to making a treatment decision
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* Presence of transplant kidney
* Unwilling or unable to complete informed consent
* Previous biopsy of small renal mass.
18 Years
95 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
UNC Lineberger Comprehensive Cancer Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Hung J Tan, MD
Role: PRINCIPAL_INVESTIGATOR
UNC Lineberger Comprehensive Cancer Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
LCCC 1834
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.