NCT07789119

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50,000

participants targeted

Target at P75+ for all trials

Timeline
145mo left

Started Feb 2027

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 18, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 27, 2026

Completed
5 months until next milestone

Study Start

First participant enrolled

February 6, 2027

Expected
9.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2036

2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2038

Last Updated

August 27, 2026

Status Verified

August 1, 2026

Enrollment Period

9.9 years

First QC Date

August 18, 2026

Last Update Submit

August 24, 2026

Conditions

Prospective CollectionMolecular AnalysisBiospecimensUrothelial Carcinoma (UC)Urinary Tract

Outcome Measures

Primary Outcomes (1)

  • Overall Survival

    Through study completion; an average of 1 year

Interventions

biospecimen CollectionDIAGNOSTIC_TEST

biospecimen collection during routine care encounters or clinically indicated procedures

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

UT MD Anderson Cancer Center

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Carcinoma, Transitional Cell

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Study Officials

  • Byron Lee, MD

    UT MD Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Byron Lee, MD

CONTACT

713-792-3250BHLee@mdanderson.org

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 18, 2026

First Posted

August 27, 2026

Study Start (Estimated)

February 6, 2027

Primary Completion (Estimated)

December 31, 2036

Study Completion (Estimated)

December 31, 2038

Last Updated

August 27, 2026

Record last verified: 2026-08

Locations

US(1)