Prospective Collection And Molecular Analysis Of Biospecimens And Clinical Data From Patients With Urothelial Carcinoma And Related Malignancies Of The Urinary Tract

August 24, 2026 updated by: M.D. Anderson Cancer Center
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

50000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • UT MD Anderson Cancer Center
        • Contact:
        • Principal Investigator:
          • Byron Lee, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

UT MD Anderson Cancer Center

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall Survival
Time Frame: Through study completion; an average of 1 year
Through study completion; an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Investigators

  • Principal Investigator: Byron Lee, MD, UT MD Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 6, 2027

Primary Completion (Estimated)

December 31, 2036

Study Completion (Estimated)

December 31, 2038

Study Registration Dates

First Submitted

August 18, 2026

First Submitted That Met QC Criteria

August 24, 2026

First Posted (Actual)

August 27, 2026

Study Record Updates

Last Update Posted (Actual)

August 27, 2026

Last Update Submitted That Met QC Criteria

August 24, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2026-0828
  • NCI-2026-06211 (Other Identifier: NCI-CTRP Clinical Registry)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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