Urothelial CancerNCT04923178
A Multi-Center Natural History of Urothelial Cancer and Rare Genitourinary Tract Malignancies
An observational study of Urothelial Cancer and Bladder Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Background: Tumors in the genitourinary tracts can occur in the kidney, bladder, prostate, and testicles and can have common and rare histologies. Some cancers that occur along the genitourinary (GU) tract are rare. Some GU tumors are so rare that they are not included in treatment studies or tissue banks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urothelial Cancer, Bladder Cancer, Genitourinary Cancer
- How many people
- 1,100 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Oct 2022to 1 Dec 2042
- 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: primary clinical
Who may be able to join
- Participants must have histologically or cytologically confirmed urothelial or rare genitourinary cancer including but not limited to the following: small cell carcinoma of the bladder; adenocarcinoma of the bladder; squamous cell carcinoma of the bladder; plasmacytoid urothelial carcinoma; any penile cancer; any testicular cancer, sarcomatoid renal cell carcinoma; sarcomatoid urothelial carcinoma; renal medullary carcinoma or other miscellaneous histologic variants of the urothelial carcinoma, such as, but not limited to micropapillary, giant cell, lipid-rich, clear cell and nested variants, large cell neuroendocrine carcinoma, lymphoepithelioma-like carcinoma and mixed patterns will be considered, as well as small cell neuroendocrine prostate cancer, testicular Sertoli or Leydig cell tumors. Any genitourinary cancer can be included at the principal investigator's discretion.
- Age >=18 years.
- Ability of participant to understand and the willingness to sign a written informed consent document.
Who cannot join
- -None
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
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
For more information at the NIH Clinical Center contact National Cancer Institute Referral Office, 888-624-1937
About this study
Background:
Tumors in the genitourinary tracts can occur in the kidney, bladder, prostate, and testicles and can have common and rare histologies. Some cancers that occur along the genitourinary (GU) tract are rare. Some GU tumors are so rare that they are not included in treatment studies or tissue banks. This makes it hard for researchers to determine standards of care. Researchers want to learn more about common and rare GU tumors.
Read more
Objective:
To learn more about urinary tract cancers.
Eligibility:
People ages 18 and older with urinary tract or GU cancer such as bladder, kidney, testicular, prostate, penis, or neuroendocrine cancer.
Design:
Participants will be screened with questions about their medical history. Their medical records will be reviewed.
Participants will have a physical exam. They will give blood and urine samples. They will complete a survey about their family cancer history. Clinical photographs will be taken to document skin lesions.
Participants may have imaging scans of their chest, abdomen, and pelvis. They may have a contrast agent injected into their arm.
Participants will get recommendations about how to best manage and treat their cancer. They can ask as many questions as they would like.
Participants will provide existing tumor samples if available. They may have optional tumor biopsies up to twice a year. For needle biopsies, the biopsy area will be numbed and they will get a sedative. A needle will be inserted through their skin to collect a tumor sample. For skin biopsies, their skin will be numbed. A small circle of skin will be removed.
Some blood and tumor samples may be used for genetic tests.
Participants will have frequent follow-up visits. If they cannot visit NIH, their home doctor will be contacted. They will be followed on this study for life....
Read the detailed description
Background:
- Histological variants of the genitourinary (GU) tract include bladder/urachal adenocarcinoma, squamous cell carcinoma, and small cell carcinoma; variants of urothelial carcinoma including plasmacytoid, sarcomatoid; renal tumors including sarcomatoid renal cell carcinoma and renal medullary carcinoma; penile cancers; micropapillary, giant cell, lipid rich, clear cell and nested variants, large cell neuroendocrine carcinoma, lymphoepithelioma-like carcinoma and mixed patterns; small cell neuroendocrine carcinoma of the prostate, testicular Sertoli or Leydig cell tumors, and papillary and chromophobe renal cell carcinoma (RCC).
- Some GU tumors occur so infrequently that they are not systematically captured by currently available registries, treatment protocols, or tissue banks. The rarity of these tumors limits the sufficient numbers of patients needed in larger randomized clinical studies to characterize standard treatments or disease course.
- Systematic and longitudinal collection and annotation of clinical history, tissue samples, imaging studies, and other pertinent information in participants with these rare tumors will yield future knowledge and help with the development of subsequent prospective studies to optimize diagnosis and treatment paradigms for less common GU tumors.
Objective:
-Characterization of the natural history of urothelial and GU tract malignancies.
Eligibility:
-Participants >= 18 years of age diagnosed with urothelial or GU tract malignancies.
Design:
- This will be a long-term multi-center study to comprehensively study participants with GU tumors.
- Medical history will be collected, and participants followed throughout the course of their illnesses, with particular attention to patterns of disease presentation, recurrence and progression, response to therapies, and duration of responses.
- Tissue samples and blood will be obtained from participants during this study.
- A broad spectrum of scientific experiments, including genomics and immune monitoring will be performed.
- We anticipate accruing 1000 participants on this protocol.
- Conditions
- Urothelial Cancer, Bladder Cancer, Genitourinary Cancer, Urogenital Neoplasms, Urogenital Cancer
- Keywords
- bladder/urachal adenocarcinoma, renal tumors, penile cancers, small cell neuroendocrine carcinoma of the prostate, Renal Cell Carcinoma, Natural History
- Medical subject headings
- Urinary Bladder Neoplasms, Urogenital Neoplasms, Urachal adenocarcinoma, Carcinoma, Renal Cell, Penile Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 / Urothelial cancer | Participants with urothelial cancer. | |
| 2 / Rare Bladder or Urinary Tract Histology | Participants with small cell carcinoma, adenocarcinoma, urachal squamous cell carcinoma, or pure sarcomatoid carcinoma. These pure histologies can occur in the bladder and/or urinary tract. | |
| 3 / Urothelial Carcinoma Variants | Participants diagnosed with a urothelial variant histologies at any stage. | |
| 4 / Rare GU Tumors | Participants with renal medullary carcinoma, testicular Sertoli or Leydig cell tumors, penile cancer, refractory germ cell tumors. |
What is being measured
The primary outcome is the main question the study is designed to answer.
natural history of urothelial and rare genitourinary cancer
clinical presentation, patterns of disease progression, therapeutic response, disease recurrence and participant overall survival
Measured: ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2021
- Study start24 Oct 2022
- Primary completion1 Dec 2041 (estimated)
- Study completion1 Dec 2042 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urothelial CancerStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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
- 1,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Andrea B Apolo, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04923178
- Sponsor's protocol ID
- 10000302
- Other IDs
- 000302-C
- Status last verified
- 13 Oct 2026
- First submitted
- 10 Jun 2021
- Last updated
- 16 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD recorded in the medical record will be shared with intramural investigators upon request. @@@@@@In addition, all large scale genomic sequencing data will be shared with subscribers to dbGaP.
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center Natural History of Urothelial Cancer and Rare Genitourinary Tract Malignancies
- ClinicalTrials.gov ID
- NCT04923178
- Acronym / sponsor ID
- 10000302
- Conditions
- Urothelial Cancer, Bladder Cancer, Genitourinary Cancer, Urogenital Neoplasms, Urogenital Cancer
- Keywords
- bladder/urachal adenocarcinoma, renal tumors, penile cancers, small cell neuroendocrine carcinoma of the prostate, Renal Cell Carcinoma, Natural History
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,100 participants (estimated)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 24 Oct 2022 (actual)
- Primary completion
- 1 Dec 2041 (estimated)
- Study completion
- 1 Dec 2042 (estimated)
- First posted
- 11 Jun 2021 (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.
Background:
Tumors in the genitourinary tracts can occur in the kidney, bladder, prostate, and testicles and can have common and rare histologies. Some cancers that occur along the genitourinary (GU) tract are rare. Some GU tumors are so rare that they are not included in treatment studies or tissue banks. This makes it hard for researchers to determine standards of care. Researchers want to learn more about common and rare GU tumors.
Objective:
To learn more about urinary tract cancers.
Eligibility:
People ages 18 and older with urinary tract or GU cancer such as bladder, kidney, testicular, prostate, penis, or neuroendocrine cancer.
Design:
Participants will be screened with questions about their medical history. Their medical records will be reviewed.
Participants will have a physical exam. They will give blood and urine samples. They will complete a survey about their family cancer history. Clinical photographs will be taken to document skin lesions.
Participants may have imaging scans of their chest, abdomen, and pelvis. They may have a contrast agent injected into their arm.
Participants will get recommendations about how to best manage and treat their cancer. They can ask as many questions as they would like.
Participants will provide existing tumor samples if available. They may have optional tumor biopsies up to twice a year. For needle biopsies, the biopsy area will be numbed and they will get a sedative. A needle will be inserted through their skin to collect a tumor sample. For skin biopsies, their skin will be numbed. A small circle of skin will be removed.
Some blood and tumor samples may be used for genetic tests.
Participants will have frequent follow-up visits. If they cannot visit NIH, their home doctor will be contacted. They will be followed on this study for life....
Detailed description
Background:
- Histological variants of the genitourinary (GU) tract include bladder/urachal adenocarcinoma, squamous cell carcinoma, and small cell carcinoma; variants of urothelial carcinoma including plasmacytoid, sarcomatoid; renal tumors including sarcomatoid renal cell carcinoma and renal medullary carcinoma; penile cancers; micropapillary, giant cell, lipid rich, clear cell and nested variants, large cell neuroendocrine carcinoma, lymphoepithelioma-like carcinoma and mixed patterns; small cell neuroendocrine carcinoma of the prostate, testicular Sertoli or Leydig cell tumors, and papillary and chromophobe renal cell carcinoma (RCC).
- Some GU tumors occur so infrequently that they are not systematically captured by currently available registries, treatment protocols, or tissue banks. The rarity of these tumors limits the sufficient numbers of patients needed in larger randomized clinical studies to characterize standard treatments or disease course.
- Systematic and longitudinal collection and annotation of clinical history, tissue samples, imaging studies, and other pertinent information in participants with these rare tumors will yield future knowledge and help with the development of subsequent prospective studies to optimize diagnosis and treatment paradigms for less common GU tumors.
Objective:
-Characterization of the natural history of urothelial and GU tract malignancies.
Eligibility:
-Participants >= 18 years of age diagnosed with urothelial or GU tract malignancies.
Design:
- This will be a long-term multi-center study to comprehensively study participants with GU tumors.
- Medical history will be collected, and participants followed throughout the course of their illnesses, with particular attention to patterns of disease presentation, recurrence and progression, response to therapies, and duration of responses.
- Tissue samples and blood will be obtained from participants during this study.
- A broad spectrum of scientific experiments, including genomics and immune monitoring will be performed.
- We anticipate accruing 1000 participants on this protocol.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 / Urothelial cancer | – | –Participants with urothelial cancer. |
| 2 / Rare Bladder or Urinary Tract Histology | – | –Participants with small cell carcinoma, adenocarcinoma, urachal squamous cell carcinoma, or pure sarcomatoid carcinoma. These pure histologies can occur in the bladder and/or urinary tract. |
| 3 / Urothelial Carcinoma Variants | – | –Participants diagnosed with a urothelial variant histologies at any stage. |
| 4 / Rare GU Tumors | – | –Participants with renal medullary carcinoma, testicular Sertoli or Leydig cell tumors, penile cancer, refractory germ cell tumors. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- primary clinical
Key inclusion criteria (3 listed)
- Participants must have histologically or cytologically confirmed urothelial or rare genitourinary cancer including but not limited to the following: small cell carcinoma of the bladder; adenocarcinoma of the bladder; squamous cell carcinoma of the bladder; plasmacytoid urothelial carcinoma; any penile cancer; any testicular cancer, sarcomatoid renal cell carcinoma; sarcomatoid urothelial carcinoma; renal medullary carcinoma or other miscellaneous histologic variants of the urothelial carcinoma, such as, but not limited to micropapillary, giant cell, lipid-rich, clear cell and nested variants, large cell neuroendocrine carcinoma, lymphoepithelioma-like carcinoma and mixed patterns will be considered, as well as small cell neuroendocrine prostate cancer, testicular Sertoli or Leydig cell tumors. Any genitourinary cancer can be included at the principal investigator's discretion.
- Age >=18 years.
- Ability of participant to understand and the willingness to sign a written informed consent document.
Key exclusion criteria (1 listed)
- -None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
natural history of urothelial and rare genitourinary cancer
Time frame: ongoing
clinical presentation, patterns of disease progression, therapeutic response, disease recurrence and participant overall survival
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 16 Oct 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All IPD recorded in the medical record will be shared with intramural investigators upon request. @@@@@@In addition, all large scale genomic sequencing data will be shared with subscribers to dbGaP.
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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.
Andrea B Apolo, M.D. principal investigator
National Cancer Institute (NCI)
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 Cancer and Bladder Cancer, run by National Cancer Institute (NCI) 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 3 inclusion and 1 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 16 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 Tzu-Fang Wang, R.N. ((240) 858-3236, tzu-fang.wang@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
natural history of urothelial and rare genitourinary cancer (time frame: ongoing). 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 16 Oct 2026.