Bladder CancerNCT02164942
LCI-GU-BLA-SPEC-001: Aurora Kinase Expression in Muscle-Invasive Bladder Cancer
An observational study of Bladder Cancer, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
This is a prospective, single arm, observational study examining aurora kinases and circulating tumor cells in subjects with bladder cancer being treated with standard cisplatin-based chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Feb 2016
- 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: Patients with muscle-invasive urothelial carcinoma of the bladder
Who may be able to join
- Histologically confirmed American Joint Committee on Cancer seventh edition clinical stage T2-4a N0-3 urothelial carcinoma of the bladder based on diagnostic transurethral bladder biopsy or transurethral resection of bladder tumor (TURBT) confirming the presence of urothelial carcinoma with muscularis propria invasion.
- Archived tissue from prior biopsy/resection must be available for baseline AK analysis.
- Subjects must be eligible to undergo radical cystectomy and cisplatin-based chemotherapy.
- Subjects with radiographically enlarged lymph nodes (short axis >10 mm with CT scan or MRI) should undergo percutaneous biopsy for staging in accordance with local practices, though preferred, is not mandatory for study enrollment.
- A baseline computed tomography (CT) scan with intravenous contrast of the chest, abdomen and pelvis is required in all subjects. A radionuclide bone scan is also required in subjects with skeletal pain or abnormally elevated alkaline phosphatase values.
- Age at least 18 years old.
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- ECOG performance status of 0 or 1.
- Bilirubin less than 1.5 mg/dL.
- Subjects must have adequate liver function: AST and ALT less than 2.5x upper limit of normal, alkaline phosphatase less than 2.5x upper limit of normal.
- Subjects must have adequate bone marrow function: Platelets greater than 100,000 cells/mm3, Hemoglobin greater than 9.0g/dL and ANC greater than 1,500 cells/mm3.
- Subjects must have adequate renal function with creatinine clearance of at least 60 mL/min.
- Subjects must sign a written informed consent document and authorization for release of their medical records for the purposes of research.
Who cannot join
- Pure non-urothelial or mixed small cell histology identified within TURBT specimen.
- Absence of documented urothelial carcinoma with muscularis propria invasion on diagnostic transurethral bladder biopsy or transurethral resection of bladder tumor (TURBT).
- Distant metastatic disease, including non-regional lymphadenopathy and visceral metastases, identified on pretreatment radiographic studies.
- Creatinine clearance less than 60 mL/min.
- CTCAE version 4 grade 2 or greater hearing loss.
- CTCAE version 4 grade 2 or greater peripheral neuropathy.
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- NYHA class III heart failure or cardiac ejection fraction less than or equal to 50%.
- Women of child-bearing age who are pregnant or breast feeding.
- Uncontrolled and current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Subjects with other active malignancies as defined as synchronous malignancy at the time of bladder cancer diagnosis, excluding non-metastatic, non-melanoma skin cancer are excluded.
- Major surgery within 4 weeks of consent.
- Subjects requiring therapeutic anticoagulation at the time of consent.
- Currently enrolled on another clinical trial for the treatment of bladder cancer.
Trial locations and contacts
1 site in 1 country.
United States1 site
Carolinas Healthcare System
Charlotte, North Carolina, 28203
About this study
Official title: LCI-GU-BLA-SPEC-001: Expression of the Aurora Kinase Family and Chemoresistance in Muscle-Invasive Bladder Cancer
This is a prospective, single arm, observational study examining aurora kinases and circulating tumor cells in subjects with bladder cancer being treated with standard cisplatin-based chemotherapy.
Read the detailed description
Subjects will receive neoadjuvant cisplatin-based chemotherapy followed by radical cystectomy per standard of care. CTC and Aurora kinase expression patterns will be analyzed in subject specimens for correlation with clinicopathologic outcome. Subjects will be on study for a total of five years following cystectomy.
- Conditions
- Bladder Cancer
- Medical subject headings
- Urinary Bladder 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 |
|---|---|---|
| Single Arm | Specimen Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of pathologic response rate and aurora kinase expression
Measured: Within 6 months of subject enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionFeb 2016
- Study completionFeb 2016
Why it stopped: Futility
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe 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
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- University of Miami
- Responsible party
- Sponsor
- Investigators
- Tesa M Adams, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02164942
- Sponsor's protocol ID
- LCI-GU-BLA-SPEC-001
- Other IDs
- 00009729
- Status last verified
- Aug 2017
- First submitted
- 13 Jun 2014
- Last updated
- 26 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LCI-GU-BLA-SPEC-001: Expression of the Aurora Kinase Family and Chemoresistance in Muscle-Invasive Bladder Cancer
- ClinicalTrials.gov ID
- NCT02164942
- Acronym / sponsor ID
- LCI-GU-BLA-SPEC-001
- Conditions
- Bladder Cancer
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Futility
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- University of Miami
- Study start
- Jun 2014
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 17 Jun 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.
This is a prospective, single arm, observational study examining aurora kinases and circulating tumor cells in subjects with bladder cancer being treated with standard cisplatin-based chemotherapy.
Detailed description
Subjects will receive neoadjuvant cisplatin-based chemotherapy followed by radical cystectomy per standard of care. CTC and Aurora kinase expression patterns will be analyzed in subject specimens for correlation with clinicopathologic outcome. Subjects will be on study for a total of five years following cystectomy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | – | –Specimen Collection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with muscle-invasive urothelial carcinoma of the bladder
Key inclusion criteria (12 listed)
- Histologically confirmed American Joint Committee on Cancer seventh edition clinical stage T2-4a N0-3 urothelial carcinoma of the bladder based on diagnostic transurethral bladder biopsy or transurethral resection of bladder tumor (TURBT) confirming the presence of urothelial carcinoma with muscularis propria invasion.
- Archived tissue from prior biopsy/resection must be available for baseline AK analysis.
- Subjects must be eligible to undergo radical cystectomy and cisplatin-based chemotherapy.
- Subjects with radiographically enlarged lymph nodes (short axis >10 mm with CT scan or MRI) should undergo percutaneous biopsy for staging in accordance with local practices, though preferred, is not mandatory for study enrollment.
- A baseline computed tomography (CT) scan with intravenous contrast of the chest, abdomen and pelvis is required in all subjects. A radionuclide bone scan is also required in subjects with skeletal pain or abnormally elevated alkaline phosphatase values.
Key exclusion criteria (13 listed)
- Pure non-urothelial or mixed small cell histology identified within TURBT specimen.
- Absence of documented urothelial carcinoma with muscularis propria invasion on diagnostic transurethral bladder biopsy or transurethral resection of bladder tumor (TURBT).
- Distant metastatic disease, including non-regional lymphadenopathy and visceral metastases, identified on pretreatment radiographic studies.
- Creatinine clearance less than 60 mL/min.
- CTCAE version 4 grade 2 or greater hearing loss.
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
Correlation of pathologic response rate and aurora kinase expression
Time frame: Within 6 months of subject enrollment
Results and safety
The study was stopped early (reason given: Futility). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2022.
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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.
Tesa M Adams principal investigator
Wake Forest University Health Sciences
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 Bladder Cancer, run by Wake Forest University Health Sciences 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 12 inclusion and 13 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: stopped early, as of the sponsor's last update on 26 Apr 2022. 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 was stopped early (reason given: Futility). Results are not available in the source record.
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?
Correlation of pathologic response rate and aurora kinase expression (time frame: Within 6 months of subject enrollment). 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 26 Apr 2022.