A Study to Predict Response to Virotherapy and Immunotherapy by Using an Ex-Vivo Three-Dimensional Patient-Derived Organoid Model of Pediatric Urological 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: 19-002795
Sponsor Protocol Number: 19-002795
About this study
The purpose of this study is threefold: the first aim is to use patient-derived fresh tumor tissue to create cell lines and 3D tumor models (i.e. organoids) that preserve the characteristics of the original tumor. The preservation of the original tumor's drug resistance/response profile will be a major focus of this aim. The second aim is to conduct high-throughput testing of various drugs (e.g., virotherapy, immunotherapy) on these cell lines and 3D tumor models. The completion of the second aim is an important step towards developing a platform that can help guide treatment decisions for future patients, based on the drug response observed in the cell lines and 3D tumor models. The third aim is to use pan-omics approaches (i.e., genomics, proteomics, metabolomics) to find markers of drug response based on the results of the high-throughput drug testing on the cell lines and 3D tumor models.
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:
- Any patient undergoing surgery or biopsy for malignancy in the kidney, bladder, prostate.
- Any patient undergoing resection or biopsy of tumor recurrence after surgery for malignancy in the kidney, bladder, prostate.
- Any patient undergoing resection or biopsy of tumor metastatic site after surgery for malignancy in the kidney, bladder, prostate.
Exclusion Criteria:
- Inability to provide consent.
- Specimen and data related to this pilot study will be retained for future use in case we wish to perform further related studies and include these pilot patients in ensuing analyses. In that case, re-consent of patients will be required when they turn 18.
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 Patricio Gargollo, M.D. |
Open for enrollment |
Contact information:
Cancer Center Clinical Trials Referral Office
(855) 776-0015
|
More information
Publications
Publications are currently not available