Urothelial Carcinoma of the BladderNCT02246738
Initial Evaluation of a Telomerase-based Circulating Tumor Cell Assay in Bladder Cancer Cohorts
An observational study of Urothelial Carcinoma of the Bladder, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial summary
Purposes are to determine whether various cohorts of bladder cancer patients have detectable tCTC's, determine it tCTC levels vary with the natural history of bladder cancer and to see if tCTC's provide novel information.Study population are various cohorts of patients diangosed with urothelial carcinoma of the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urothelial Carcinoma of the Bladder
- What is being tested?
- Blood Collection
- How many people
- 87 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Urothelial Carcinoma of the Bladder
Who may be able to join
- a.Urothelial carcinoma or mixed urothelial carcinoma arising from the bladder
- b.Age 18 or older
- Inclusions by cohort Cohort 1. Patients with localized muscle-invasive disease (cT1,cN0, M0) at the time of initial diagnosis or who have progressed from superficial disease (cT2) who have not had any systemic chemotherapy and who will be treated with upfront radical cystectomy. PriorTURBT and intravesical therapies are allowed but should not have been done within one week of CTC measurement. If the patient is found to have no evidence of tumor (pT0) upon evaluation of the cystectomy specimen, the patient will not be dropped. If the patient is found to have evidence of progression by any clinical evaluation performed within 2 months of the post-treatment sample, the patient will be dropped from Cohort 1 and included in Cohort 9 instead.
- Cohort 2. Patients with localized muscle-invasive disease (cT1, cN0, M0) at the time of initial diagnosis prior to definitivechemo-radiation. Prior TURBT and intravesical therapies are allowed but should not have been done within one week of CTC measurement. If the patient is found to have evidence of progression by anyclinical evaluation performed within 2 months of the post-treatment sample, the patient will be droppedfrom Cohort 2 and included in Cohort 9 instead.
- Cohort 3. Patients with localized muscle-invasive disease (cT1, cN0, M0) at the time of initial diagnosis or who have progressed from superficial disease (cT2) who have not had any systemic chemotherapy and who will be treated with neoadjuvant chemotherapy. Prior TURBT and intravesical therapies are allowed but should not have been done within one week of CTC measurement. If the patient is found to have evidence of progression by any clinical evaluation performed within 2 months of the post-treatment sample, the patient will be dropped from Cohort 3 and included in Cohort 9 instead.
- Cohort 4. Patients with metastatic disease (anyT, anyN, M1) at initial presentation or recurrent after definitive treatment prior to any salvage systemic chemotherapy. If the patient is found to have evidence of progression by any clinical evaluation performed within 2 months of the post-treatment sample, the patient will be dropped from Cohort 4 and included in Cohort 9 instead.
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- Cohort 5. Patients with newly diagnosed non-muscle-invasive bladder cancer (T2) prior to any intravesical therapy. If the patient is found to have evidence of progression by any clinical evaluation performed within 2 months of the post-treatment sample, the patient will be dropped.
- Cohort 6. Patients with muscle-invasive bladder cancer after radical cystectomy with or without peri-operative systemic chemotherapy (pT2, anyN, M0) who will be treated with adjuvant radiation. If the patient is found to have evidence of progression by any clinical evaluation performed within 2 months of the post-treatment sample, the patient will be dropped from Cohort 6 and includedin Cohort 9 instead.
- Cohort 7. Patients with a history of muscle invasive bladder cancer (cT1, any N,M0) who have no evidence of disease at least 2 years after the date of radical cystectomy. If the patient is found to have evidence of progression by any clinical evaluation performed within 2 months of the post-treatment sample, the patient will be dropped from Cohort 7 but may be considered for inclusion in Cohort 4.
- Cohort 8. Patients with a history of muscle invasive bladder cancer (cT1, any N, M0) who have no evidence of disease at least 2 years after the completion of definitive chemo-radiation. If the patient is found to have evidence of progression by any clinical evaluation performed within 2 months of the post-treatment sample, the patient will be dropped from Cohort 8 but may be considered for inclusion in Cohort 4.
- Cohort 9. Patients who were initially included in Cohorts 1-6 but were found to have progression at the time of their post-treatment blood draw. Of note, patients may be included in more than one cohort over time so long as inclusion and exclusion criteria are met. In addition, twenty samples from normal controls without any history of malignancy will be used for this study but havealready been collected as part of a separate protocol.
Who cannot join
- pure squamous or pure adenocarcinoma bladder cancer histology. This exclusion may be waved at the discretion of the protocol PI. 2. Prior cancer diagnosed within 3 years of enrollment other than a prior bladder, prostate, or skin cancer. This exclusion may be waved at the discretion of the protocol PI.
Trial locations and contacts
1 site in 1 country.
United States1 site
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Purposes are to determine whether various cohorts of bladder cancer patients have detectable tCTC's, determine it tCTC levels vary with the natural history of bladder cancer and to see if tCTC's provide novel information.Study population are various cohorts of patients diangosed with urothelial carcinoma of the bladder.Procedures include a venous blood draw, up to two times, over a 6 month period for collection of tCTC's. Up to 15 mL's of blood will be collected at each blood draw.
- Conditions
- Urothelial Carcinoma of the Bladder
- Being tested
- Blood Collection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood CollectionOther
| Study group | Role | What they receive |
|---|---|---|
| Cohort1 | Not described Receives: Other: Blood Collection | |
| Cohort 2 | Not described Receives: Other: Blood Collection | |
| Cohort 3 | Not described Receives: Other: Blood Collection | |
| Cohort 4 | Not described Receives: Other: Blood Collection | |
| Cohort 5 | Not described Receives: Other: Blood Collection | |
| Cohort 6 | Not described Receives: Other: Blood Collection | |
| Cohort 7 | Not described Receives: Other: Blood Collection | |
| Cohort 8 | Not described Receives: Other: Blood Collection | |
| Cohort 9 | Not described Receives: Other: Blood Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Adverse Events
Measured: 4 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2014 (estimated)
- Study startAug 2014
- Primary completionAug 2018
- Study completionOct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urothelial Carcinoma of the BladderStudies of the same condition, open and under way.
- More trials run by Abramson Cancer Center at Penn MedicineThe 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
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John Christodouleas, MD, Principal investigator, Abramson Cancer Center at Penn Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02246738
- Sponsor's protocol ID
- UPCC 07814
- Status last verified
- Dec 2020
- First submitted
- 18 Sep 2014
- Last updated
- 10 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Initial Evaluation of a Telomerase-based Circulating Tumor Cell Assay in Bladder Cancer Cohorts
- ClinicalTrials.gov ID
- NCT02246738
- Acronym / sponsor ID
- UPCC 07814
- Conditions
- Urothelial Carcinoma of the Bladder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Study start
- Aug 2014 (actual)
- Primary completion
- Aug 2018 (actual)
- Study completion
- Oct 2020 (actual)
- First posted
- 23 Sep 2014 (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.
Purposes are to determine whether various cohorts of bladder cancer patients have detectable tCTC's, determine it tCTC levels vary with the natural history of bladder cancer and to see if tCTC's provide novel information.Study population are various cohorts of patients diangosed with urothelial carcinoma of the bladder.Procedures include a venous blood draw, up to two times, over a 6 month period for collection of tCTC's. Up to 15 mL's of blood will be collected at each blood draw.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Cohort1 | – | Other: Blood Collection |
| Cohort 2 | – | Other: Blood Collection |
| Cohort 3 | – | Other: Blood Collection |
| Cohort 4 | – | Other: Blood Collection |
| Cohort 5 | – | Other: Blood Collection |
| Cohort 6 | – | Other: Blood Collection |
| Cohort 7 | – | Other: Blood Collection |
| Cohort 8 | – | Other: Blood Collection |
| Cohort 9 | – | Other: Blood Collection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Urothelial Carcinoma of the Bladder
Key inclusion criteria (11 listed)
- a.Urothelial carcinoma or mixed urothelial carcinoma arising from the bladder
- b.Age 18 or older
- Inclusions by cohort Cohort 1. Patients with localized muscle-invasive disease (cT1,cN0, M0) at the time of initial diagnosis or who have progressed from superficial disease (cT2) who have not had any systemic chemotherapy and who will be treated with upfront radical cystectomy. PriorTURBT and intravesical therapies are allowed but should not have been done within one week of CTC measurement. If the patient is found to have no evidence of tumor (pT0) upon evaluation of the cystectomy specimen, the patient will not be dropped. If the patient is found to have evidence of progression by any clinical evaluation performed within 2 months of the post-treatment sample, the patient will be dropped from Cohort 1 and included in Cohort 9 instead.
- Cohort 2. Patients with localized muscle-invasive disease (cT1, cN0, M0) at the time of initial diagnosis prior to definitivechemo-radiation. Prior TURBT and intravesical therapies are allowed but should not have been done within one week of CTC measurement. If the patient is found to have evidence of progression by anyclinical evaluation performed within 2 months of the post-treatment sample, the patient will be droppedfrom Cohort 2 and included in Cohort 9 instead.
- Cohort 3. Patients with localized muscle-invasive disease (cT1, cN0, M0) at the time of initial diagnosis or who have progressed from superficial disease (cT2) who have not had any systemic chemotherapy and who will be treated with neoadjuvant chemotherapy. Prior TURBT and intravesical therapies are allowed but should not have been done within one week of CTC measurement. If the patient is found to have evidence of progression by any clinical evaluation performed within 2 months of the post-treatment sample, the patient will be dropped from Cohort 3 and included in Cohort 9 instead.
Key exclusion criteria (1 listed)
- pure squamous or pure adenocarcinoma bladder cancer histology. This exclusion may be waved at the discretion of the protocol PI. 2. Prior cancer diagnosed within 3 years of enrollment other than a prior bladder, prostate, or skin cancer. This exclusion may be waved at the discretion of the protocol PI.
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 |
|---|---|---|
| Blood Collection | Other | Cohort 2, Cohort 3, Cohort 4, Cohort 5, Cohort 6, Cohort 7, Cohort 8, Cohort 9, Cohort1 |
Primary outcome
Number of Adverse Events
Time frame: 4 Years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2020.
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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.
John Christodouleas, MD principal investigator
Abramson Cancer Center at Penn Medicine
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 of the Bladder, run by Abramson Cancer Center at Penn Medicine 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 11 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: finished, as of the sponsor's last update on 10 Dec 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of Adverse Events (time frame: 4 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 10 Dec 2020.