Purpose of this Study
We are doing this study to find out if a medical technology called the Signatera blood test can help doctors and patients determine the best course of treatment for bladder cancer after the patient has a radical cystectomy (removal of the bladder and surrounding lymph nodes). The Signatera test is used to detect cancer DNA in the blood before cancer can be seen using imaging (like MRI or CT scans).
Who Can Participate?
Eligibility
Adults ages 18+ who:
- Are diagnosed with urothelial cancer of the bladder
- Had a radical cystectomy (RC) surgery at least 3 weeks, but no more than 12 weeks, before joining the study
- Have no evidence of remaining disease after RC surgery
- Have not had any postoperative/adjuvant systemic therapy or radiation
- Have never been treated with any PD-1 or PD-L1 axis inhibitors
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
This study wants to find out if a blood test can help doctors make better choices about who should get immunotherapy after bladder cancer surgery and which treatment is the best. DNA is the material inside every cell that tells the cell how to work. Cancer cells often have DNA that looks different from normal DNA. New tests can find bladder cancer DNA in the blood, which may show that cancer cells are still in the body. Researchers want to see if this information can help guide treatment after the bladder is removed.
Locations
Duke University Hospital
Duke Raleigh Hospital
Other
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
Yes
Study Details
Full Title
A032103: MODERN: An Integrated Phase 2/3 and Phase 3 Trial of MRD-Based Optimization of Adjuvant Therapy in Urothelial Cancer
Principal Investigator
Hannah
McManus
Protocol Number
PRO00116700
NCT ID
NCT05987241
Phase
II/III
Enrollment Status
Open to Enrollment