Retrospective Chart Review of Valstar

Completed

Conditions studied: Carcinoma in Situ of Bladder

In brief

This is an observational study involving a retrospective review of medical records of adult patients who have been treated with intravesical valrubicin for bladder carcinoma in situ (CIS) since October 2009.

Key facts

Study ID

NCT01304173

Run by

Endo USA Inc., a Keenova Therapeutics Company

People needed

113

Starts

2011-03-01

Expected to finish

2011-10-01

Last updated by the study team

2014-02-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• age 18 years old or greater
• diagnosis of CIS (physician defined in the medical record)
• treated with at least one IVe dose of valrubicin since 10/2009 and completed prescribed therapy or no longer receiving therapy at time of study enrollment
• willing and able to provide informed consent (unless waiver of informed consent is applicable and in place at that clinical site per Chapter 45 CFR part 46 Subpart A 46.117

You may not qualify if…

• route of administration of valrubicin other than intravesical

Where it is running

• Vanderbilt University — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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