Urothelial CancerNCT00902590
A Genotype-Phenotype Urothelial Cancer Registry
An observational study of Urothelial Cancer and Renal Pelvis Cancer, run by Memorial Sloan Kettering Cancer Center at 4 sites in United States.
Trial summary
This study is being done to create a registry to help us learn more about urinary and other cancers. This will let us look at large groups of people who do and do not have this kind of cancer. The investigators will look at risk factors to learn more about how these impact cancer. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Urothelial Cancer, Renal Pelvis Cancer, Ureter Cancer
- What is being tested?
- saliva sample and questionaire and saliva sample, questionaire
- How many people
- 3,519 participants
- Where
- 4 sitesUnited States
- Study dates
- May 2009to 31 May 2027
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: A member of the patient's treatment team, the protocol investigator, or a member of the research team at Memorial Sloan-Kettering Cancer Center (MSKCC) will identify potential research subjects. At MSKCC the following outpatient clinics will be used to recruit UC cases: Urology and Genitourinary Oncology. Patients and families may also be directly referred to the study team by any MSKCC physician, external physician, or by the family itself.
Who may be able to join
- Urothelial Cancer Cases
- Must be ≥ 18 years of age AND
- Must have a diagnosis of urothelial cancer AND
- Must be an English-speaker
- Non-Cancer Control Group
- Must be ≥ 18 years of age AND
Show all 15Show fewer
- Must not have cancer or a personal history of cancer, with the exception of skin cancer. AND
- Must not be a blood relative of cases AND
- Must not be a blood relative of another control AND
- Must be an English-speaker
- Family Member Control Group:
- In select kindreds with a high prevalence of bladder cancer and/or very early onset bladder cancer, first- and second-degree family members of probands may be contacted by the MSKCC study team and invited to complete the questionnaire and submit a saliva sample.
- Must be ≥ 18 years of age AND
- Must be a blood relative of a case participant AND
- Must be an English-speaker
Who cannot join
- Have any condition, which in the opinion of the primary MSKCC clinician or investigators precludes their ability to provide informed consent.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920
Memorial Sloan Kettering Commack
Commack, New York, 11725
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Memorial Sloan Kettering Nassau
Uniondale, New York, 11553
About this study
This study is being done to create a registry to help us learn more about urinary and other cancers. This will let us look at large groups of people who do and do not have this kind of cancer.
The investigators will look at risk factors to learn more about how these impact cancer. The investigators will also look at genetic markers. These are genes that are found in a known place. They are often associated with a particular trait. If the gene changes in some way, it may predict cancer or response to treatment. The investigators will look for markers in your saliva.
This registry will help us develop better methods of:
Preventing these cancers. Diagnosing these cancers. Treating these cancers.
- Conditions
- Urothelial Cancer, Renal Pelvis Cancer, Ureter Cancer, Bladder Cancer
- Being tested
- saliva sample and questionaire, saliva sample, questionaire
- Keywords
- renal pelvis, ureter, bladder, 09-025, Renal Pelvis, Ureter, Bladder Cancer
- Medical subject headings
- Ureteral Neoplasms, Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
saliva sample and questionaireOther
Urothelial Cancer Registry- Patients will complete a family history and urothelial cancer risk questionnaire, and will provide a buccal sample for germline DNA. If the cases have undergone germline sequencing as part of Protocol 12-245, they will not need to provide a buccal sample. If the cases have previously completed athe "the "Urothelial Baseline Questionnaire," in an MSKCC urology clinic they will not need to complete the urothelial cancer risk questionnaire.
saliva sample, questionaireOther
Urothelial Cancer Registry- These participants will be requested to complete the risk factor questionnaire and to provide a saliva sample for DNA extraction.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients with urothelial cancer Receives: Other: saliva sample and questionaire | |
| 2 | unrelated adults accompanying patients to clinic Receives: Other: saliva sample, questionaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine whether single nucleotide polymorphisms in regions discovered from whole genome scans, such as 8q24 & chromosome 3, & candidate genes, include NAT2 & GSTM1, prev found to be assoc with bladder ca risk, are assoc with UC in this study population
Measured: 2 years
Secondary outcomes (1)
To determine whether single nucleotide polymorphisms in the genes and regions listed above are associated with outcomes after UC diagnosis in the population
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2009 (estimated)
- Study startMay 2009
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (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 Memorial Sloan Kettering 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 3,519 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of Chicago, Fox Chase Cancer Center
- Responsible party
- Sponsor
- Investigators
- Iyer Gopakumar, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00902590
- Sponsor's protocol ID
- 09-025
- Status last verified
- Aug 2026
- First submitted
- 14 May 2009
- Last updated
- 24 Aug 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Genotype-Phenotype Urothelial Cancer Registry
- ClinicalTrials.gov ID
- NCT00902590
- Acronym / sponsor ID
- 09-025
- Conditions
- Urothelial Cancer, Renal Pelvis Cancer, Ureter Cancer, Bladder Cancer
- Keywords
- renal pelvis, ureter, bladder, 09-025, Renal Pelvis, Ureter, Bladder Cancer
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 3,519 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- University of Chicago, Fox Chase Cancer Center
- Study start
- May 2009
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 15 May 2009 (estimated)
- 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.
This study is being done to create a registry to help us learn more about urinary and other cancers. This will let us look at large groups of people who do and do not have this kind of cancer.
The investigators will look at risk factors to learn more about how these impact cancer. The investigators will also look at genetic markers. These are genes that are found in a known place. They are often associated with a particular trait. If the gene changes in some way, it may predict cancer or response to treatment. The investigators will look for markers in your saliva.
This registry will help us develop better methods of:
Preventing these cancers. Diagnosing these cancers. Treating these cancers.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: saliva sample and questionairePatients with urothelial cancer |
| 2 | – | Other: saliva sample, questionaireunrelated adults accompanying patients to clinic |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A member of the patient's treatment team, the protocol investigator, or a member of the research team at Memorial Sloan-Kettering Cancer Center (MSKCC) will identify potential research subjects. At MSKCC the following outpatient clinics will be used to recruit UC cases: Urology and Genitourinary Oncology. Patients and families may also be directly referred to the study team by any MSKCC physician, external physician, or by the family itself.
Key inclusion criteria (15 listed)
- Urothelial Cancer Cases
- Must be ≥ 18 years of age AND
- Must have a diagnosis of urothelial cancer AND
- Must be an English-speaker
- Non-Cancer Control Group
Key exclusion criteria (1 listed)
- Have any condition, which in the opinion of the primary MSKCC clinician or investigators precludes their ability to provide informed consent.
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 |
|---|---|---|
| saliva sample and questionaireUrothelial Cancer Registry- Patients will complete a family history and urothelial cancer risk questionnaire, and will provide a buccal sample for germline DNA. If the cases have undergone germline sequencing as part of Protocol 12-245, they will not need to provide a buccal sample. If the cases have previously completed athe "the "Urothelial Baseline Questionnaire," in an MSKCC urology clinic they will not need to complete the urothelial cancer risk questionnaire. | Other | 1 |
| saliva sample, questionaireUrothelial Cancer Registry- These participants will be requested to complete the risk factor questionnaire and to provide a saliva sample for DNA extraction. | Other | 2 |
Primary outcome
Determine whether single nucleotide polymorphisms in regions discovered from whole genome scans, such as 8q24 & chromosome 3, & candidate genes, include NAT2 & GSTM1, prev found to be assoc with bladder ca risk, are assoc with UC in this study population
Time frame: 2 years
1 secondary outcome
To determine whether single nucleotide polymorphisms in the genes and regions listed above are associated with outcomes after UC diagnosis in the population
Time frame: 2 years
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 24 Aug 2026.
- Memorial Sloan Kettering 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. This study is not recruiting at the moment.
Iyer Gopakumar, MD principal investigator
Memorial Sloan Kettering Cancer Center
4 sites 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 Renal Pelvis Cancer, run by Memorial Sloan Kettering Cancer Center at 4 sites 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 15 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: under way, not looking for participants, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine whether single nucleotide polymorphisms in regions discovered from whole genome scans, such as 8q24 & chromosome 3, & candidate genes, include NAT2 & GSTM1, prev found to be assoc with bladder ca risk, are assoc with UC in this study population (time frame: 2 years). 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 24 Aug 2026.