Impact of Surgical Removal or Reduction Procedures on Markers of Immune Function in Adult Patients with Renal and Bladder Tumors and Pediatric Patients with Genitourinary Tumors
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 16-006956
Sponsor Protocol Number: 16-006956
About this study
The purpose of this study is to find out more about certain markers of immune suppression in people with kidney tumors (whether the tumors are benign or cancer). Also want to find out if kidney tumor treatment leads to an improvement in these immune markers.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria
Subjects ≥ 18 years of age:
- Age 18+ years
- Able to give informed consent
- Undergoing elective treatment for a solid renal/bladder tumor:
- Partial nephrectomy/cystectomy
- Radical nephrectomy/cystectomy
- Nephrectomy + tumor thrombectomy
- Cytoreductive nephrectomy +/- metastasectomy for metastatic RCC
- Radiofrequency ablation or cryotherapy
- Transurethral resection
- Metastasectomy for mUC
Subjects < 18 years of age:
- Age 0-17 years
- Parent/Guardian able to give informed consent, and subject able to give assent (ages 7-17)
- Undergoing elective treatment for genitourinary mass, and/or metastases from primary genitourinary tumor, and/or recurrence of genitourinary malignancy, any location, with tissue being obtained via:
- Nephrectomy
- Partial nephrectomy
- Open biopsy
- Percutaneous biopsy
- Resection of mass
Exclusion Criteria
Subjects ≥ 18 years of age:
- Bilateral tumors
- Salvage procedure (i.e. treatment for a recurrent tumor)
- Immunosuppressed patient (Use of immunosuppressive medications in past 90 days (Examples include: oral or IV corticosteroids (topical creams or nasal sprays are OK), anti-metabolites (ex. azathioprine, methotrexate), biologics (ex. infliximab), chemotherapy) or imunosuppressive condition (ex. transplant, immunodeficiency syndromes, HIV/AIDS)
- Auto-immune disease (ex. lupus, rheumatoid arthritis, inflammatory bowel disease, etc.)
- Pregnancy
Subjects < 18 years of age:
- Metastases to kidney from non-renal primary
- Auto-immune disease (ex. lupus, rheumatoid arthritis, inflammatory bowel disease, etc.)
- Pregnancy
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Bradley Leibovich, M.D. |
Open for enrollment |
|
More information
Publications
Publications are currently not available