Urothelial CarcinomaNCT07789119
Prospective Collection And Molecular Analysis Of Biospecimens And Clinical Data From Patients With Urothelial Carcinoma And Related Malignancies Of The Urinary Tract
An observational study of Urothelial Carcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urothelial Carcinoma
- What is being tested?
- biospecimen Collection
- How many people
- 50,000 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Sep 2026to 31 Dec 2038
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: UT MD Anderson Cancer Center
Who may be able to join
None listed.
Who cannot join
- Age younger than 18 years.
- Unable to understand the study information or unable to personally provide informed consent.
- Declines participation.
- 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.
- 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.
- Prisoners or other populations requiring additional regulatory protections not specifically approved under this protocol.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UT MD Anderson Cancer Center
Houston, Texas, 77030
Bryon Lee, MD, 713-792-3250, BHLee@mdanderson.org
Byron Lee, MD
About this study
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.
Read the 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.
- Conditions
- Urothelial Carcinoma
- Being tested
- biospecimen Collection
- Medical subject headings
- Carcinoma, Transitional Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biospecimen CollectionDiagnostic test
biospecimen collection during routine care encounters or clinically indicated procedures
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Measured: Through study completion; an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2026
- Study start10 Sep 2026
- Primary completion31 Dec 2036 (estimated)
- Study completion31 Dec 2038 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urothelial CarcinomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Byron Lee, MD, Principal investigator, UT MD Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07789119
- Sponsor's protocol ID
- 2026-0828
- Other IDs
- NCI-2026-06211
- Status last verified
- Sep 2026
- First submitted
- 18 Aug 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Collection And Molecular Analysis Of Biospecimens And Clinical Data From Patients With Urothelial Carcinoma And Related Malignancies Of The Urinary Tract
- ClinicalTrials.gov ID
- NCT07789119
- Acronym / sponsor ID
- 2026-0828
- Conditions
- Urothelial Carcinoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50,000 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 10 Sep 2026 (actual)
- Primary completion
- 31 Dec 2036 (estimated)
- Study completion
- 31 Dec 2038 (estimated)
- First posted
- 27 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- UT MD Anderson Cancer Center
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- Age younger than 18 years.
- Unable to understand the study information or unable to personally provide informed consent.
- Declines participation.
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| biospecimen Collectionbiospecimen collection during routine care encounters or clinically indicated procedures | Diagnostic test | – |
Primary outcome
Overall Survival
Time frame: Through study completion; an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- UT MD Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Byron Lee, MD principal investigator
UT MD Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urothelial Carcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Byron Lee, MD (713-792-3250, BHLee@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: Through study completion; an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.