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Trial of Single-Dose Intravesical EOquin® as a Surgical Adjuvant Instilled in the Early Postoperative Period in Patients Undergoing TUR-BT
Basic Trial Information
Trial Description
Summary
Further Trial Information
Eligibility Criteria
Trial Contact Information
Basic Trial Information
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Protocol IDs
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Phase III
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Treatment
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Active
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18 and over
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Pharmaceutical / Industry
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SPI-611
NCT00461591
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Trial Description
Summary The purpose of this study is to evaluate the recurrence rate of noninvasive bladder cancer at 2 years in patients with tumor histology Ta, G1-G2 who are randomized to receive TUR-BT plus EOquin® versus those who are randomized to receive TUR-BT plus placebo. Further Study Information This is a multicenter, randomized, placebo-controlled, double-blind, study. Following TUR-BT, eligible patients will be randomized to receive either intravesical EOquin® or matching placebo instilled within 6 hours of surgery. Patients will be seen for a postoperative follow-up exam 21±10 days after the TUR. At this time, the pathology report will be reviewed. If the histology of the patient's tumor is Ta, G1-G2 (low grade [WHO/ISUP classification]), then the patient will receive no further treatment and will be observed cystoscopically every three months through year two for tumor recurrence and progression. If the histology of the patient's tumor is other than Ta, G1-G2 (low grade [WHO/ISUP classification]), then the patient will receive further treatment in accordance with current treatment guidelines, following which the patient will be followed up cystoscopically every three months through year two for tumor recurrence and progression. Eligibility Criteria Inclusion Criteria: (All questions must be answered YES) - Has the patient given written informed consent?
- Is the patient at least 18 years old?
- Does the patient have transitional cell carcinoma of the bladder with clinically apparent stage Ta, grade G1-G2?
- If the patient is a female of childbearing potential, is she using an acceptable/effective method of contraception?
- If the patient is a female of childbearing potential, has she had a negative serum pregnancy test within the past 14 days?
- Is the patient willing and able to abide by the protocol?
Exclusion Criteria: (All questions must be answered NO) - Does the patient have more than 4 bladder tumors?
- Does any single bladder tumor exceed 3.5 cm in diameter?
- Does the patient have a single, primary (no previous diagnosis of TCC) bladder tumor <0.5 cm?
- Has the patient ever received EOquin(r)?
- Does the patient have, or has the patient ever had, any bladder tumor known to be other than stage Ta or grade G1 or G2 (low grade [WHO/ISUP classification])?
- Does the patient have, or has the patient ever had any bladder tumor with histology other than transitional cell carcinoma?
- Does the patient have, or has the patient ever had, CIS?
- Does the patient have an active urinary tract infection?
- Does the patient have a bleeding disorder or a screening platelet count < 100 x 10^9/L?
- Does the patient have any unstable medical condition that would make it unsafe for him/her to undergo TUR-BT under general or spinal anesthesia?
- Does the patient have a screening hemoglobin < 10 mg/dL, a screening absolute neutrophil count < 1.5 x 10^9/L or a screening creatinine > 2 mg/dL?
- Does the patient have a known immunodeficiency disorder?
- Has the patient received any investigational treatment within the past 30 days?
- Is the patient breast feeding?
- Does the patient have a history of interstitial cystitis?
- Does the patient have a history of allergy to red color food dye?
- Has the patient had transitional cell carcinoma of the bladder within the past 4 months?
Trial Contact Information
Trial Lead Organizations/Sponsors Spectrum Pharmaceuticals, Incorporated | Mark Soloway, MD | | Principal Investigator |
Trial Sites
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| U.S.A. |
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| Arizona |
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Phoenix |
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| | | | | | | | | Bladder Cancer Genitourinary Oncology, PC |
| | | Kay Johnson |
Ph: 602-493-6626 |
| | | Donald L. Lamm | Principal Investigator |
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Sun City |
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| | | Sun Health Research Institute |
| | | Carolyn Liebsack |
Ph: 623-875-6514 |
| | | Jeffery Stern, MD, MPH | Principal Investigator |
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| California |
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Laguna Woods |
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| | | | South Coast Urological Medical Group |
| | | Christy Leach, RN |
Ph: 949-499-2279 |
| | | Jay Young, MD | Principal Investigator |
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| Colorado |
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Denver |
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| | | | Urology Center of Colorado |
| | | Sarah Koceja |
Ph: 303-421-5783 |
| | | Lawrence Karsh, MD | Principal Investigator |
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| Connecticut |
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Middlebury |
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| | | | Connecticut Clinical Research Center, LLC
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| | | Brendaliz Konopka |
Ph: 203-757-2296 |
| | | Robert Feldman, MD | Principal Investigator |
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| Florida |
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Longwood |
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| | | | Urology Consultants - Longwood |
| | | Stacey Kinsey |
Ph: 407-332-0777 |
| | | Steven Brooks, MD | Principal Investigator |
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Miami |
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| | | University of Miami Sylvester Comprehensive Cancer Center - Miami |
| | | Dinorah Rodriguez |
Ph: 305-243-7207 |
| | | Mark Soloway, MD | Principal Investigator |
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New Port Richey |
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| | | Urology Health Center |
| | | Gabrielle Handerson |
Ph: 727-835-3261 |
| | | Juan Otheguy, MD | Principal Investigator |
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Ocala |
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| | | Florida Foundation for Healthcare Research |
| | | Joanne Grover |
Ph: 352-237-3949 |
| | | Ira Klimberg, MD | Principal Investigator |
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Sarasota |
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| | | Florida Urology Specialists - Sarasota |
| | | Shannon Lynch |
Ph: 941-309-7000 Ext.7116 |
| | | Thomas Williams, MD | Principal Investigator |
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Tallahassee |
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| | | Southeastern Research Group |
| | | Mary Anne Taylor |
Ph: 850-201-0411 |
| | | J. Daniel Rackley, MD | Principal Investigator |
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Tampa |
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| | | Tampa Bay Urology |
| | | Linda Seibert |
Ph: 813-872-7881 |
| | | Tod Fusia, MD | Principal Investigator |
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| Idaho |
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Meridian |
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| | | | Idaho Urologic Institute, PA |
| | | Katie Gries |
Ph: 208-639-4938 |
| | | Stephen Miller, MD | Principal Investigator |
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| Illinois |
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Chicago |
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| | | | University of Chicago Cancer Research Center |
| | | Josephine Silvestre |
Ph: 773-702-3080 |
| | | Gary Steinberg, MD | Principal Investigator |
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Peoria |
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| | | Specialty Care Research |
| | | Jackie Schultz |
Ph: 309-683-1125 |
| | | Giovanni Colombo, MD | Principal Investigator |
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| Indiana |
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Ft. Wayne |
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| | | | Northeast Indiana Research, LLC |
| | | Mary Hageman, RN |
Ph: 260-434-1939 |
| | | Christopher Steidle, MD | Principal Investigator |
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Jeffersonville |
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| | | Metropolitan Urology, PSC |
| | | Debbie Johnson |
Ph: 812-288-2611 |
| | | James Bailen, MD | Principal Investigator |
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| Kansas |
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Overland Park |
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| | | | Kansas City Urology Care |
| | | John Beuscher |
Ph: 913-647-4173 |
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Email:
jbeuscher@kcurology.com |
| | | Steven Nash, MD | Principal Investigator |
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| Maryland |
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Annapolis |
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| | | | Anne Arundel Urology, PA |
| | | Elizabeth D'Antonio |
Ph: 410-266-8049 Ext.143 |
| | | Eric Schwartz, MD | Principal Investigator |
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Greenbelt |
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| | | Werner-Francis Urology Associates, LLC |
| | | Lisa Drezer, MD |
Ph: 301-441-8900 Ext.114 |
| | | Myron I. Murdock | Principal Investigator |
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| Montana |
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Missoula |
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| | | | Five Valleys Urology |
| | | Jennifer Hays |
Ph: 406-329-2864 |
| | | Karl Westenfelder, MD | Principal Investigator |
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| New Jersey |
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Lawrenceville |
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| | | | Lawrenceville Urology |
| | | Julie Prettyman |
Ph: 609-895-1991 |
| | | Gary Karlin, MD | Principal Investigator |
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Marlton |
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| | | Delaware Valley Urology, LLC - Marlton |
| | | Diane Horner |
Ph: 856-985-4286 |
| | | Charles Orth, Jr., MD | Principal Investigator |
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Sewell |
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| | | Delaware Valley Urology, LLC - Sewell Washington Township |
| | | Michelle Redman |
Ph: 856-218-3025 |
| | | Robert Barsky, DO | Principal Investigator |
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Voorhees |
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| | | Center for Urologic Care at Centennial Medical Center |
| | | Catherine Kavalchick |
Ph: 856-751-5288 |
| | | Louis Keeler, MD | Principal Investigator |
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Westampton |
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| | | Delaware Valley Urology, LLC - Westampton |
| | | Rene Haney |
Ph: 609-914-0021 Ext.125 |
| | | Robert Goldlust, MD | Principal Investigator |
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| New Mexico |
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Albuquerque |
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| | | | Urology Group of New Mexico |
| | | Mary Lou Jones |
Ph: 505-872-4090 Ext.118 |
| | | Frederick J. Snoy | Principal Investigator |
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| New York |
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Garden City |
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| | | | AccuMed Research Associates |
| | | Kerri Weingard |
Ph: 516-746-2190 |
| | | Mitchell Efros, MD | Principal Investigator |
| | | Urological Surgeons of Long Island |
| | | Vincent Gandolfo |
Ph: 516-742-3200 |
| | | Robert Edelman, MD | Principal Investigator |
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Kingston |
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| | | Hudson Valley Urology, PC - Kingston Office |
| | | Jeanie Hefele |
Ph: 845-339-4900 Ext.110 |
| | | Jose Sotolongo, MD | Principal Investigator |
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New York |
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| | | University Urology Associates |
| | | Betsy Ortiz |
Ph: 212-686-9015 Ext.9 |
| | | Jed Kaminetsky, MD | Principal Investigator |
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Oneida |
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| | | Oneida Healthcare Center |
| | | Tracy Griffith |
Ph: 315-363-8862 |
| | | Bashar Omarbasha, MD | Principal Investigator |
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Poughkeepsie |
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| | | Hudson Valley Urology, PC |
| | | Alexa Harrington |
Ph: 845-458-8730 |
| | | Evan Goldfischer, MD | Principal Investigator |
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Rochester |
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| | | Urology Associates of Rochester - Clinton Crossing |
| | | Eileen Stone |
Ph: 585-232-2980 |
| | | David Dever, MD | Principal Investigator |
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| Ohio |
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Cincinnati |
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| | | | Tri-State Urologic Services |
| | | Vicki Rice |
Ph: 513-366-3412 |
| | | Bernard L Hertzman, MD | Principal Investigator |
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Cleveland |
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| | | University Urologists of Cleveland, Inc. |
| | | Claudia Lillibridge |
Ph: 216-844-8205 |
| | | Edward Cherullo, MD | Principal Investigator |
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| Oregon |
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Springfield |
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| | | | Oregon Urology Institute |
| | | Janice Bebee |
Ph: 541-284-5508 |
| | | Peter Bergreen, MD | Principal Investigator |
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| Pennsylvania |
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Bala Cynwyd |
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| | | | Urologic Consultants of South Eastern Pennsylvania |
| | | Cheryl Zinar |
Ph: 610-667-0458 |
| | | Lawrence Belkoff, MD | Principal Investigator |
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Lancaster |
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| | | Urological Associates of Lancaster, Limited |
| | | Dorie Rodriguez |
Ph: 717-431-2285 |
| | | Paul Seiber, MD | Principal Investigator |
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Philadelphia |
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| | | Fox Chase Cancer Center - Philadelphia |
| | | Christine Jerome |
Ph: 215-728-3853 |
| | | Richard E. Greenberg | Principal Investigator |
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Pittsburgh |
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| | | Triangle Urological Group |
| | | Chantall Mitchell |
Ph: 412-281-1757 |
| | | John Lyne, MD | Principal Investigator |
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| South Carolina |
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Myrtle Beach |
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| | | | Grand Strand Urology, LLP |
| | | Lori Gormanns |
Ph: 843-449-1010 Ext.251 |
| | | Neal D. Shore | Principal Investigator |
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| Tennessee |
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Germantown |
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| | | | Conrad Pearson Clinic |
| | | Kathleen Meier |
Ph: 901-252-3402 |
| | | Lynn Conrad, MD | Principal Investigator |
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| Texas |
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Corpus Christi |
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| | | | Corpus Christi Urology Group LLC |
| | | Christi Grunberg |
Ph: 361-884-6381 |
| | | Robert Naismith, MD | Principal Investigator |
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Dallas |
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| | | Urology Clinics of North Texas - Dallas |
| | | Nicolette Ruiz |
Ph: 214-691-1902 |
| | | James Cochran, MD | Principal Investigator |
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San Antonio |
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| | | Urology San Antonio, PA - Fredericksburg |
| | | Beatrice Escamilla |
Ph: 210-617-4116 |
| | | Daniel R. Saltzstein | Principal Investigator |
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| Virginia |
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Norfolk |
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| | | | Urology of Virginia - Norfolk |
| | | Jennifer Kucenski |
Ph: 757-457-5166 |
| | | Robert Given, MD | Principal Investigator |
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Virginia Beach |
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| | | Devine-Tidewater Urology - Virginia Beach |
| | | Laurie Jackson |
Ph: 757-457-5462 |
| | | Kim Ramsey |
Ph: 757-457-5462 |
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| Washington |
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Mountlake Terrace |
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| | | | Integrity Medical Research, LLC |
| | | Cherrie Sia |
Ph: 425-275-0680 |
| | | Karny Jacoby, MD | Principal Investigator |
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Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00461591
Information obtained from ClinicalTrials.gov on July 16, 2008 Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain
the same text. Minor
changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and
contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should
be directed to ClinicalTrials.gov.
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