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Biomarker Identification for Bladder Cancer Patients

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ClinicalTrials.gov Identifier: NCT02053662
Recruitment Status : Unknown
Verified April 2017 by Arnab Chakravarti, Ohio State University Comprehensive Cancer Center.
Recruitment status was:  Recruiting
First Posted : February 4, 2014
Last Update Posted : April 13, 2017
Sponsor:
Information provided by (Responsible Party):
Arnab Chakravarti, Ohio State University Comprehensive Cancer Center

Brief Summary:
To develop a simple blood and urine test that we would perform before patients start their treatment to predict the risk that their bladder cancer might come back. To develop this test the investigators plan to analyze blood, urine and cancer tissue from bladder cancer patients and follow them closely during and after treatment. This will include looking for changes in proteins and genes that might play a role in bladder cancer biology. The investigators will then compare the information obtained from the studies of blood, urine and cancer tissue between patients that are cured and those whose cancer comes back. The knowledge about these differences between patients can then potentially be used to develop a blood or urine test to tell us who has a high risk for having bladder cancer come back.

Condition or disease Intervention/treatment
Bladder Cancer Procedure: Sample Collection

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Study Type : Observational
Estimated Enrollment : 179 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Biomarker Identification for Bladder Cancer Patients
Actual Study Start Date : January 21, 2014
Estimated Primary Completion Date : November 30, 2018
Estimated Study Completion Date : November 30, 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Bladder Cancer Patients
Patients with muscle invasive bladder cancer. A sample collection of donated cancer and normal adjacent tissues, blood and urine which will be prospectively obtained from patients through the Tissue Procurement Shared Resources (TPSR) and The Ohio State University Comprehensive Cancer Center Biospecimen and Biorepository Resource (BBR) as needed.
Procedure: Sample Collection
A collection of donated cancer and normal adjacent tissues, blood and urine which will be prospectively obtained from patients through the Tissue Procurement Shared Resources (TPSR) and The Ohio State University Comprehensive Cancer Center Biospecimen and Biorepository Resource (BBR) as needed.




Primary Outcome Measures :
  1. Identify novel biomarkers for bladder cancer [ Time Frame: up to 5 years ]
    Predict and detect bladder cancer recurrence, specifically through development of biomarkers using bladder cancer tissue samples as well as blood and urine samples. Detect the recurrence of disease through development of blood and urine biomarkers using pre-therapy and post-therapy biospecimens.


Biospecimen Retention:   Samples With DNA
bladder cancer tissue samples, blood, urine


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with suspected muscle-invasive bladder cancer and appropriate control population
Criteria

Inclusion Criteria:

  • Adult patients ≥18 years old.
  • Patients suspected, clinically diagnosed, or histologically diagnosed bladder cancer.
  • Patients undergoing cystoscopy without cancer suspicion.
  • Ability to give an informed consent.

Exclusion Criteria:

  • Patients receiving concurrent therapy for a second malignancy.
  • < 18 years old.
  • Inability to give an informed consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02053662


Contacts
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Contact: Ohio State University Comprehensive Cancer Center 1-800-293-5066 Jamesline@osumc.edu

Locations
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United States, Ohio
The Ohio State University Comprehensive Cancer Center Recruiting
Columbus, Ohio, United States, 43210
Contact: The Ohio State University Comprehensive Cancer Center    800-293-5066    Jamesline@osumc.edu   
Contact: Arnab Chakavarti, MD    614-293-8415    Arnab.Chakravarti@osumc.edu   
Sub-Investigator: Tim Lautenschlaeger, MD         
Sub-Investigator: Douglas Martin, MD         
Sub-Investigator: Ahmad Shabsigh, MD         
Sub-Investigator: Kamal Pohar, MD         
Sub-Investigator: Steven Clinton, MD         
Sub-Investigator: Amir Mortazavi, MD         
Sub-Investigator: Debra Zynger, MD         
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
Investigators
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Principal Investigator: Arna Chakravarti, MD The Ohio State University Cancer Center

Additional Information:
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Responsible Party: Arnab Chakravarti, Principal Investigator, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT02053662     History of Changes
Other Study ID Numbers: OSU-12158
First Posted: February 4, 2014    Key Record Dates
Last Update Posted: April 13, 2017
Last Verified: April 2017

Keywords provided by Arnab Chakravarti, Ohio State University Comprehensive Cancer Center:
Bladder Cancer

Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases