LCI-GU-BLA-SPEC-001: Aurora Kinase Expression in Muscle-Invasive Bladder Cancer

April 20, 2022 updated by: Wake Forest University Health Sciences

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
6

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
        • Carolinas Healthcare System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with muscle-invasive urothelial carcinoma of the bladder

Description

Inclusion Criteria

  • 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.
  • 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.

Exclusion Criteria

  • 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.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Single Arm
Specimen Collection

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Correlation of pathologic response rate and aurora kinase expression
Time Frame: Within 6 months of subject enrollment
Within 6 months of subject enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wake Forest University Health Sciences

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Miami

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Tesa M Adams, Wake Forest University Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 13, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 13, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 17, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 26, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 20, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LCI-GU-BLA-SPEC-001
  • 00009729

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings