ClinicalTrials.gg
Sign In
RecruitingNCT07789119Updated Oct 5, 2026

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 in Urothelial Carcinoma, sponsored by M.D. Anderson Cancer Center. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-05.

Sponsored by M.D. Anderson Cancer Center · Observational

From the registry’s dates

  • Started Sep 2026; still recruiting 2 months later.
Updated Oct 5, 2026Now RecruitingSite recruiting status changed+1 moreGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50,000
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Urothelial Carcinoma
03

In context

Carcinoma, Transitional Cell

633 studies on the registry are indexed under Carcinoma, Transitional Cell; 181 are open to participants now.

This study's planned enrollment of 50,000 is above the median of 300 across 107 observational studies indexed under Carcinoma, Transitional Cell.

Browse Carcinoma, Transitional Cell studies →

Lead sponsor

M.D. Anderson Cancer Center is the lead sponsor of 3,047 studies on the registry; 578 are open to participants now.

Of its 612 completed or terminated interventional studies of FDA-regulated products, 409 (67%) have results posted.

Browse M.D. Anderson Cancer Center studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

UT MD Anderson Cancer Center

Eligibility 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 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 .
  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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50,000 participants (estimated)
Patient registry
No

Interventions

  • Diagnostic testbiospecimen Collection

    biospecimen collection during routine care encounters or clinically indicated procedures

06

What researchers measure

Primary outcomes

  1. Overall Survival

    Time frame: Through study completion; an average of 1 year

07

Study locations

1 of 1 sites recruiting
08

References and documents

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2026 (actual). Primary completion is estimated for Dec 2036, 123 months after the start.

Of 60 observational studies under Carcinoma, Transitional Cell, half reached primary completion within 56 months of starting (the median), counting those still running; a quarter within 27. This study's planned 123 months is above that.

Start moved once since we started tracking on Sep 25, 2026: Feb 2027 → Sep 2026, on Oct 5, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Aug 18, 2026
First posted
Aug 27, 2026
StartActual
Sep 10, 2026was Feb 2027
Primary completionEst.
Dec 31, 2036
CompletionEst.
Dec 31, 2038
Last update
Oct 5, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Not yet recruiting→Recruiting
changed Oct 5, 2026
Sites
UT MD Anderson Cancer Center is now Recruiting
Oct 5, 2026
Start date
Feb 6, 2027→Sep 10, 2026 (actual)
Oct 5, 2026
Show all 1 update
  1. Oct 5, 2026
    Not yet recruiting→Recruiting
    UT MD Anderson Cancer Center is now Recruiting
    Start date Feb 6, 2027→Sep 10, 2026 (now actual)
    + 2 other changes: verification date and conditions

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07789119
Lead sponsor
M.D. Anderson Cancer Center
Responsible party
Sponsor
First posted
Aug 27, 2026
Start date
Sep 10, 2026
Primary completion
Dec 31, 2036 (estimated)
Completion
Dec 31, 2038 (estimated)
Last update
Oct 5, 2026

Study contacts

Byron Lee, MD
Contact
BHLee@mdanderson.org
713-792-3250
Byron Lee, MD
principal investigator · UT MD Anderson Cancer Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Carcinoma, Transitional Cell →

Other studies from this sponsor

M.D. Anderson Cancer Center →

Start the discussion