Surgical Drain Fluid for Detection of Molecular Residual Disease (MRD) in Bladder, Renal and Urothelial Cancers
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: 24-013778
Sponsor Protocol Number: 24-013
About this study
The purpose of this study is to investigate if DNA cancer-associated-variants (CAV) in post-operative blood, tumor tissue and surgical drain fluid can correlate molecular residual disease (MRD) with clinical, radiographic, or pathologic progression at 12- and 24- months post-surgery in patients with bladder, renal or urothelial cancer.
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:
Cohorts 1 and 2: Bladder, Renal or Upper Tract Urothelial Cancer
- 18 years or older.
- Currently diagnosed with bladder, renal or upper tract urothelial cancer
- Scheduled or will be scheduled for primary surgical resection with curative intent, with use of post-surgical drain.
- The participant is cognitively able to consent to participate in the study.
- The participant is healthy enough for blood draws and sample collection (at the discretion of the Investigator).
Cohorts 3 and 4: Non-malignant Comparators
- 18 years or older.
- The participant is cognitively able to consent to participate in the study.
- The participant is healthy enough for a blood draw and sample collection (at the discretion of the Investigator).
- The patient has no history of a cancer diagnosis.
- Is scheduled to undergo a non-malignancy related surgical procedure, for example bladder reconstruction for congenital anomalies, prophylactic cystectomy in patients with somatic mutations, blunt or penetrating bladder trauma repairs, any non-malignancy related pelvic surgery requiring drain placement for urinoma prevention which result in the use of surgical drain placements similar to those in cohorts 1 and 2.
Exclusion Criteria:
Cohorts 1 and 2: Bladder, Renal or Upper Tract Urothelial Cancer
- Participant does not meet all inclusion criteria.
- Subject deemed not fit to participate at the Investigator’s discretion.
- Participant has a history of a previous cancer diagnosis, other than: non-melanomatous localized cutaneous malignancies (e.g., SCC, BCC); non-metastatic prostate cancer; and non-metastatic well differentiated thyroid cancers within the last 5 years.
COHORTS 3 and 4: Non-malignant Comparators
- Participant does not meet all inclusion criteria.
- Subject deemed not fit to participate at the Investigator’s discretion.
- Participant undergoing surgery for infectious etiology.
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 11/05/2024. Questions regarding updates should be directed to the study team contact.
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 |
Contact |
Rochester, Minn.
Mayo Clinic principal investigator Robert Karnes, M.D. |
Contact us for the latest status |
Contact information:
Cancer Center Clinical Trials Referral Office
(855) 776-0015
|
More information
Publications
Publications are currently not available