NCT01314664

Brief Summary

The purpose of this study is to observe and describe the effectiveness and local tolerability of intravesical treatment with valrubicin for non-muscle invasive bladder cancer (NMIBC) in a cohort of subjects treated under routine practice conditions.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2011

Shorter than P25 for all trials

Geographic Reach
1 country

11 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 11, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 14, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2011

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

June 12, 2015

Status Verified

June 1, 2015

Enrollment Period

8 months

First QC Date

March 11, 2011

Last Update Submit

June 10, 2015

Conditions

Bladder CancerCIS

Keywords

Non-Muscle Invasive Bladder CancerCISBCG Refractory

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

subjects who will be receiving intravesical valrubicin treatment for NMIBC

You may qualify if:

  • Males and females 18 years of age and older
  • Diagnosed with NMIBC
  • Prescribed intravesical valrubicin to treat NMIBC
  • Understood and signed Informed Consent to participate

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

BCG Oncology

Phoenix, Arizona, 85032, United States

Location

Urology Research Network

Hialeah, Florida, 33149, United States

Location

Advanced Urology Association of Florida

Vero Beach, Florida, 32960, United States

Location

Kansas City Urology Care

Overland Park, Kansas, 66211, United States

Location

Delaware Valley Urology

Sewell, New Jersey, 08080, United States

Location

Delaware Valley Urology

Voorhees Township, New Jersey, 08043, United States

Location

Long Island Urological Associates

Bethpage, New York, 11714, United States

Location

Urologic Consultants of SE PA

Bala-Cynwyd, Pennsylvania, 19004, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Urology Associates of North Texas

Arlington, Texas, 76017, United States

Location

Urology Clinics of North Texas

Dallas, Texas, 75231, United States

Location

MeSH Terms

Conditions

Urinary Bladder NeoplasmsNon-Muscle Invasive Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital DiseasesCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Officials

  • Todd Kirby, PhD

    Endo

    STUDY DIRECTOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2011

First Posted

March 14, 2011

Study Start

May 1, 2011

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

June 12, 2015

Record last verified: 2015-06

Locations

US(11)