NCT03819569Completed
GRADE-SRM: Genomic Risk Assessment and Decisional Evaluation for Small Renal Masses
Source: ClinicalTrials.gov · Last updated 3 Jul 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 265 (actual)
- First submitted
- 29 Nov 2018
- Start date
- 30 Oct 2018
- Primary completion date
- 18 Apr 2024
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Diseases
- Kidney cancer
- NCT number
- NCT03819569
What you commit to
- Study type: Interventional
- Participants enrolled: 265
- From 30 Oct 2018 to the primary completion date, 18 Apr 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Presence of transplant kidney
- Previous biopsy of small renal mass.
Other illness
- Has staging information indicating locally advanced or metastatic disease.
Other
- Unwilling or unable to complete informed consent
Who the study is looking for
- 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
Age in the registry: 18 years to 95 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UNC Lineberger Comprehensive Cancer Center Coordinator of this site? Confirm its status | Chapel Hill | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.