Biospecimens, Molecular Analysis, Prospective Collection, Urinary Tract, Urothelial Carcinoma (UC)
Conditions
Brief summary
To collect, process, store, and study biological samples and related clinical and imaging data from participants with known or suspected urothelial carcinoma or another related malignancy of the urinary tract.
Detailed description
The primary objectives of this protocol are to prospectively collect, process, store, and clinically annotate biospecimens and associated data from participants with urothelial carcinoma and related malignancies of the urinary tract in order to support translational research addressing clinically important scientific questions.
Interventions
DIAGNOSTIC_TESTbiospecimen Collection
biospecimen collection during routine care encounters or clinically indicated procedures
Sponsors
M.D. Anderson Cancer Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Eligibility Criteria Participants must meet all of the following criteria for enrollment: 1. Age 18 years or older at the time of consent. 2. Known or suspected urothelial carcinoma or other related malignancy of the urinary tract for which biospecimen and associated clinical data collection is relevant to the objectives of this protocol. This may include patients undergoing diagnostic evaluation for a lesion, mass, abnormal cytology, or other clinical finding concerning for malignancy. 3. Undergoing evaluation, treatment, surveillance, follow-up care, or clinically indicated procedures at The University of Texas M.D. Anderson Cancer Center, including Houston Area Locations. 4. Able to understand and personally provide informed consent. 5. Willing to allow prospective collection, banking, storage, and research use of biospecimens and associated clinical information as described in the informed consent document.
Exclusion criteria
1. Age younger than 18 years. 2. Unable to understand the study information or unable to personally provide informed consent. 3. Declines participation. 4. No known or suspected urothelial carcinoma or other related malignancy of the urinary tract, and no clinical circumstance in which enrollment under this protocol is relevant to the study objectives. 5. Clinical, operational, or safety circumstances that make enrollment or research collection inappropriate or not feasible in the judgment of the treating clinical team or study investigators. Examples may include urgent clinical priorities, insufficient residual specimen after diagnostic needs are met, inability to safely obtain research specimens during a clinically indicated procedure, or inability to complete consent appropriately. 6. Prisoners or other populations requiring additional regulatory protections not specifically approved under this protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival | Through study completion; an average of 1 year |
Countries
United States
Contacts
CONTACTByron Lee, MD
PRINCIPAL_INVESTIGATORByron Lee, MD
UT MD Anderson Cancer Center
Outcome results
None listed