Urothelial Carcinoma Biospecimen Collection and Data Study

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an observational protocol that prospectively collects biospecimens and associated clinical data from adults with urothelial carcinoma or related urinary tract cancers. Samples are processed and stored, with clinical annotations to support research questions. The study does not test a treatment; it focuses on creating a repository for translational analyses. Participants are patients undergoing evaluation or care at MD Anderson expecting to contribute biological material and data. Informed consent is obtained, and data may be used for future research as described in the consent.

Why it matters

Who can join: the full rules

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.

Where it's running

• UT MD Anderson Cancer Center
  Houston, Texas, United States Recruiting

Study contacts

• Principal investigator: Byron Lee, MD — UT MD Anderson Cancer Center
• Study coordinator: Byron Lee, MD
• Email: BHLee@mdanderson.org
• Phone: 713-792-3250

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.