Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:15 PM
Ignite Modification Date:
2025-12-24 @ 3:15 PM
NCT ID:
NCT06965192
Eligibility Criteria:
Inclusion Criteria:
In order to participate in this study, a subject must meet all of the eligibility criteria outlined below.
* Verbal informed consent was obtained to participate in the study.
* Subject is willing and able to comply with study procedures based on the judgment of the investigator or protocol designee.
* Age ≥ 18 years at the time of consent.
* For patient subjects, HIPAA authorization for the release of personal health information and a new histologic diagnosis of localized prostate cancer based on prostate biopsy or clinical diagnosis of T1 renal mass (≤7 cm in diameter) Suspicion for kidney cancer based on cross-sectional imaging. New diagnosis is defined as within 6 months of consent. T1 renal masses include solid masses or Bosniak III/IV cystic masses.
* For physician subjects, practicing urologist in North Carolina at UNC Health, Novant Health, or an affiliated site and sees patients with suspected or confirmed prostate or kidney cancer.
Exclusion Criteria:
The subjects meeting the following criteria will be excluded from study participation:
* Non-English speaking.
* Unwilling or unable to complete informed consent.
* For patient subjects:
1. Has staging information indicating locally advanced or metastatic disease. This would include PSA \>50 ng/ml, imaging suggestive of distant metastasis, or lymph node involvement, renal masses \>7 cm or invading in renal sinus or tumor thrombus.
2. Histologic or clinical diagnosis \>6 months before date of consent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06965192
Study Brief:
Protocol Section:
NCT06965192