Fase 3b-forsøg med Nadofaragene Firadenovec vs. observation hos deltagere med middelrisiko, ikke-muskelinvasiv blærekræft (ABLE-32)
28. oktober 2026 opdateret af: Ferring Pharmaceuticals
Et fase 3b, randomiseret, kontrolleret forsøg med Nadofaragene Firadenovec vs. observation hos deltagere med middelrisiko, ikke-muskelinvasiv blærekræft
A phase 3b, Randomized, Controlled Trial of Nadofaragene Firadenovec vs. Observation in Participants with Intermediate Risk Non-Muscle Invasive Bladder Cancer (IR NMIBC)
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
454
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Ferring Pharmaceuticals
- Telefonnummer: 833-548-1402
- E-mail: disclosure@ferring.com
Studiesteder
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Alberta
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Calgary, Alberta, Canada, T2V1P9
- Rekruttering
- Prostate Cancer Centre
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Ontario
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Burlington, Ontario, Canada, L7N 3V2
- Rekruttering
- G kenneth Jansz Medicine Professional Corporation
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Hamilton, Ontario, Canada, L8N 4A6
- Rekruttering
- Research St. Joseph's- Hamilton/St. Joseph's Healthcare Hamilton
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Toronto, Ontario, Canada, M5G 1Z5
- Rekruttering
- University Health Network UHN - Princess Margaret Cancer Centre
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-
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Aarhus, Danmark, 8200
- Rekruttering
- Aarhus University Hospital
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Alabama
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Mobile, Alabama, Forenede Stater, 36606
- Rekruttering
- University of South Alabama (USA) Health System - USACM
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Mobile, Alabama, Forenede Stater, 56608
- Rekruttering
- Urology Associates of Mobile
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Arizona
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Phoenix, Arizona, Forenede Stater, 85054
- Rekruttering
- Mayo Clinic Arizona
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Tucson, Arizona, Forenede Stater, 85718
- Rekruttering
- Center for Neurosciences
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Arkansas
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Little Rock, Arkansas, Forenede Stater, 72211
- Rekruttering
- Arkansas Urology, North Little Rock
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California
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Bakersfield, California, Forenede Stater, 93301
- Rekruttering
- Michael G Oefelein, MD Clinical Trials
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Fresno, California, Forenede Stater, 93720
- Rekruttering
- Urology Associates of Central California
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Los Angeles, California, Forenede Stater, 90017
- Rekruttering
- American Institute of Research
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Murrieta, California, Forenede Stater, 92563
- Rekruttering
- Urology Center of Southern California
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Orange, California, Forenede Stater, 92868
- Rekruttering
- University of California, Irvine
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Santa Monica, California, Forenede Stater, 90404
- Rekruttering
- Providence Saint John's Cancer Institute
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Colorado
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Denver, Colorado, Forenede Stater, 80210
- Rekruttering
- Advent Health
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District of Columbia
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Washington D.C., District of Columbia, Forenede Stater, 20007
- Rekruttering
- Medstar Georgetown University Hospital
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Florida
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Jacksonville, Florida, Forenede Stater, 32224
- Rekruttering
- Mayo Clinic
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Lakeland, Florida, Forenede Stater, 33805
- Rekruttering
- Lakeland Regional Health North Campus - Hollis Cancer Center
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Largo, Florida, Forenede Stater, 33771
- Rekruttering
- Advanced Urology institute - Pinellas
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Sarasota, Florida, Forenede Stater, 34239
- Rekruttering
- Sarasota Memorial Healthcare System
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Georgia
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Atlanta, Georgia, Forenede Stater, 30322
- Rekruttering
- Emory University
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Illinois
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Lisle, Illinois, Forenede Stater, 60532
- Rekruttering
- NextStage Clinical Research
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Quincy, Illinois, Forenede Stater, 62301
- Rekruttering
- Blessing Health System
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Indiana
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Jeffersonville, Indiana, Forenede Stater, 47130
- Rekruttering
- First Urology Research (Jeffersonville)
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Iowa
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Clive, Iowa, Forenede Stater, 50325
- Rekruttering
- Urology Center of Iowa Research
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Kansas
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Wichita, Kansas, Forenede Stater, 67226
- Rekruttering
- Wichita Urology Group
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Kentucky
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Lexington, Kentucky, Forenede Stater, 40536
- Rekruttering
- University of Kentucky (UK) - Markey Cancer Center
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Maryland
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Annapolis, Maryland, Forenede Stater, 21401
- Rekruttering
- Anne Arundel Urology, PA
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02115
- Rekruttering
- Beth Israel Lahey Health-Beth Israel Deaconess Medical Center (BIDMC)
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Minnesota
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Rochester, Minnesota, Forenede Stater, 55905
- Rekruttering
- Mayo Clinic - Rochester Minnesota
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Mississippi
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Southaven, Mississippi, Forenede Stater, 38654
- Rekruttering
- The Urology Group P.C
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Missouri
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Creve Coeur, Missouri, Forenede Stater, 63141
- Afsluttet
- Mercy Clinic Oncology and Hematology - David C. Pratt Cancer Center
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St Louis, Missouri, Forenede Stater, 63141
- Rekruttering
- Specialty Clinical Research of St. Louis
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Nebraska
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Omaha, Nebraska, Forenede Stater, 68114
- Rekruttering
- Adult and Pediatric Urology P.C.
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New Jersey
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Morristown, New Jersey, Forenede Stater, 07960
- Rekruttering
- Atlantic Health
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New York
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Albany, New York, Forenede Stater, 10461
- Rekruttering
- Albany Medical College
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Cheektowaga, New York, Forenede Stater, 14225
- Rekruttering
- Great Lakes Physician PC d/b/a Western New York Urology Associates
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Garden City, New York, Forenede Stater, 11530
- Rekruttering
- AccuMed Research Associates
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Lake Success, New York, Forenede Stater, 11042
- Rekruttering
- Northwell Health -The Arthur Smith Institute for Urology
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New York, New York, Forenede Stater, 10010
- Rekruttering
- Veterans Affairs New York Harbor Healthcare System - Manhattan VA Medical Center
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New York, New York, Forenede Stater, 10016
- Rekruttering
- Integrated Medical Professionals, PLLC
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Poughkeepsie, New York, Forenede Stater, 12603
- Afsluttet
- Premier Medical Group of the Hudson Valley
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The Bronx, New York, Forenede Stater, 10468
- Rekruttering
- James J. Peters VA Medical Center
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North Carolina
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Raleigh, North Carolina, Forenede Stater, 27610
- Rekruttering
- WakeMed
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Ohio
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Cincinnati, Ohio, Forenede Stater, 45267
- Rekruttering
- University of Cincinnati
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Oregon
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Portland, Oregon, Forenede Stater, 97239
- Rekruttering
- Oregon Health and Science University (Portland)
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Pennsylvania
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Bala-Cynwyd, Pennsylvania, Forenede Stater, 19004
- Rekruttering
- MidLantic Urology
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Lancaster, Pennsylvania, Forenede Stater, 17601
- Rekruttering
- Keystone Urology Specialists
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Philadelphia, Pennsylvania, Forenede Stater, 19104
- Rekruttering
- University of Pennsylvania - Perelman Center for Advanced Medicine - Penn Urology
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Pittsburgh, Pennsylvania, Forenede Stater, 15232
- Rekruttering
- University of Pittsburgh Medical Center - Shadyside Medical Building
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South Carolina
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Myrtle Beach, South Carolina, Forenede Stater, 29572
- Rekruttering
- Carolina Urologic Research Center
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Tennessee
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Germantown, Tennessee, Forenede Stater, 38138
- Rekruttering
- The Conrad Pearson Clinic - Wolf River Office (Urology Center of the South)
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Texas
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Austin, Texas, Forenede Stater, 78759
- Rekruttering
- Urology Austin
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Dallas, Texas, Forenede Stater, 75231
- Rekruttering
- Urology Clinics of North Texas PLLC (Dallas)
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Houston, Texas, Forenede Stater, 77030
- Rekruttering
- Houston Methodist Hospital (Houston)
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Houston, Texas, Forenede Stater, 77027
- Rekruttering
- Houston Metro Urology - Memorial City
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Virginia
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Virginia Beach, Virginia, Forenede Stater, 23462
- Rekruttering
- Urology of Virginia
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Washington
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Spokane, Washington, Forenede Stater, 99202
- Rekruttering
- Spokane Urology PLLC
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Paris, Frankrig, 75013
- Rekruttering
- Hopital La Pitie Salpetriere
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Auvergne-Rhône-Alpes
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Clermont-Ferrand, Auvergne-Rhône-Alpes, Frankrig, 63000
- Rekruttering
- CHU Clermont Ferrand - Hopital Gabriel Montpied
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Haute-Garonne
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Toulouse, Haute-Garonne, Frankrig, 31059
- Rekruttering
- CHU Toulouse - Hopital Rangueil
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Nantes
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Nantes, Nantes, Frankrig, 44093
- Rekruttering
- CHU Nantes - Hotel Dieu
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New Aquitaine
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Bordeaux, New Aquitaine, Frankrig, 33076
- Rekruttering
- CHU de Bordeaux - Hôpital Pellegrin
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Normandy
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Rouen, Normandy, Frankrig, 76031
- Rekruttering
- CHU de Rouen - Hopital Charles-Nicolle
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Occitanie
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Nîmes, Occitanie, Frankrig, 30229
- Rekruttering
- Centre Hospitalier Universitaire De Nimes (Nîmes)
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Rhone-Alpe
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Lyon, Rhone-Alpe, Frankrig, 69310
- Rekruttering
- Centre Hospitaliser Universitaire de Lyon Sud
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Rhône-Alps
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Lyon, Rhône-Alps, Frankrig, 69003
- Rekruttering
- Hospices Civils de Lyon - Edouard Herriot Hosp.
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Île-de-France Region
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Paris, Île-de-France Region, Frankrig, 75018
- Rekruttering
- APHP - Hopital Bichat
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Lazio
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Rome, Lazio, Italien, 00144
- Rekruttering
- Istituti Fisioterapici Ospitalieri (IFO) - Istituto Nazionale Tumori Regina Elena (IRE)
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Lombardy
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Rozzano, Lombardy, Italien, 20089
- Rekruttering
- Gruppo Humanitas - Humanitas Research Hospital (Instituto Clinico Humanitas)
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Aichi-ken
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Nagakute, Aichi-ken, Japan, 480-1195
- Rekruttering
- Aichi Medical University Hospital
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Nagoya, Aichi-ken, Japan, 466-8560
- Rekruttering
- Nagoya University Hospital
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Chiba
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Narita, Chiba, Japan, 286-8523
- Rekruttering
- Japanese Red Cross Narita Hospital
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Ehime
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Matsuyama, Ehime, Japan, 791-0280
- Rekruttering
- National Hospital Organization Shikoku Cancer Center
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Fukuoka
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Fukuoka, Fukuoka, Japan, 812-8582
- Rekruttering
- Kyushu University Hospital
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Hiroshima
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Hiroshima, Hiroshima, Japan, 734-8551
- Rekruttering
- Hiroshima University Hospital
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Hyōgo
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Kobe, Hyōgo, Japan, 650-0017
- Rekruttering
- Kobe University Hospital
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Ibaraki
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Hitachi, Ibaraki, Japan, 317-0077
- Rekruttering
- Hitachi General Hospital
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Tsukuba, Ibaraki, Japan, 305-8576
- Rekruttering
- University of Tsukuba Hospital
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Kanagawa
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Kawasaki, Kanagawa, Japan, 216-8511
- Rekruttering
- St. Marianna University Hospital
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Yokohama, Kanagawa, Japan, 236-0004
- Rekruttering
- Yokohama City University Hospital
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Kanto
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Tokyo, Kanto, Japan, 113-8655
- Rekruttering
- The University of Tokyo Hospital
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Kochi
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Nankoku, Kochi, Japan, 783-8505
- Rekruttering
- Kochi Medical School Hospital
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Mie-ken
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Tsu, Mie-ken, Japan, 514-8507
- Rekruttering
- Mie University Hospital
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Nara
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Kashihara, Nara, Japan, 634-8522
- Rekruttering
- Nara Medical University Hospital
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Tokyo
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Bunkyō-Ku, Tokyo, Japan, 113-8519
- Rekruttering
- Institute of Science Tokyo Hospital
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Wakayama
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Wakayama, Wakayama, Japan, 641-8510
- Rekruttering
- Wakayama Medical University Hospital
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Kuyavian-Pomeranian Voivodeship
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Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Polen, 85-048
- Rekruttering
- IN-VIVO Bydgoszcz
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Wielkopolska
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Poznan, Wielkopolska, Polen, 61-731
- Rekruttering
- Clinical Research Center Spółka z ograniczoną odpowiedzialnością Medic-R Sp.k.
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Woj. Mazowieckie
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Warsaw, Woj. Mazowieckie, Polen, 02-798
- Rekruttering
- Medical Concierge Centrum Medyczne
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Madrid, Spanien, 28033
- Rekruttering
- MD Anderson Cancer Center
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Madrid, Spanien, 28041
- Rekruttering
- Hospital Universitario 12 De Octubre (Madrid)
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Málaga, Spanien, 29010
- Rekruttering
- Servicio Andaluz de Salud (SAS) - Hospital Universitario Virgen de la Victoria (HUVV)
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Cantabria
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Santander, Cantabria, Spanien, 39008
- Rekruttering
- Instituto de Investigacion Valdecilla (IDIVAL) / Hospital universitario Marques de Valdecilla
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Catalonia
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Barcelona, Catalonia, Spanien, 08003
- Rekruttering
- Hospital del Mar
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Córdoba
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Córdoba, Córdoba, Spanien, 14004
- Rekruttering
- Hospital Universitario Reina Sofia
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Galicia
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A Coruña, Galicia, Spanien, 15006
- Rekruttering
- Hospital Universitario de A Coruna
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Granada
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Granada, Granada, Spanien, 18014
- Rekruttering
- Hospital Universitario Virgen De Las Nieves
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Madrid
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Alcorcón, Madrid, Spanien, 28922
- Rekruttering
- Hospital Universitario Fundacion Alcorcon
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Madrid, Madrid, Spanien, 28046
- Rekruttering
- Universidad Autonoma de Madrid. Hospital Universitario La Paz
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Vizcaya
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Bilbao, Vizcaya, Spanien, 48013
- Rekruttering
- Hospital Universitario Basurto
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Gyeonggi-do
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Goyang-si, Gyeonggi-do, Sydkorea, 10408
- Rekruttering
- National Cancer Center
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Gyeongsangnam-do
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Yangsan, Gyeongsangnam-do, Sydkorea, 50612
- Rekruttering
- Pusan National University Yangsan Hospital
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Jeollanam-do
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Hwasun, Jeollanam-do, Sydkorea, 58128
- Rekruttering
- Chonnam National University Hwasun Hospital (CNUHH)
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Seoul
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Seoul, Seoul, Sydkorea, 02841
- Rekruttering
- Korea University Anam Hospital
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Seoul, Seoul, Sydkorea, 06351
- Rekruttering
- Samsung Medical Center
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Seoul, Seoul, Sydkorea, 03722
- Rekruttering
- Severance Hospital, Yonsei University Health System
-
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Songpa-gu
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Seoul, Songpa-gu, Sydkorea, 05505
- Rekruttering
- Asan Medical Center
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Seoul, Songpa-gu, Sydkorea, 03080
- Rekruttering
- Seoul National University Hospital
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-
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-
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Kroměříž, Tjekkiet, 76701
- Rekruttering
- Kromerizska Nemocnice A S
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Liberec, Tjekkiet, 46300
- Rekruttering
- Krajska Nemocnice Liberec
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Prague, Tjekkiet, 140 59
- Rekruttering
- Fakultní Thomayerova Nemocnice
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Prague
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Prague, Prague, Tjekkiet, 160 00
- Rekruttering
- Androgeos, spol. s r.o. Location
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Prague, Prague, Tjekkiet, 140 59
- Rekruttering
- Fakultní Thomayerova Nemocnice
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
-
Diagnosed with intermediate risk non-muscle invasive bladder cancer (IR NMIBC) as defined by American Urological Association (AUA)/Society of Urologic Oncology [SUO] Guideline (2020)
-
Has undergone adequate transurethral resection of bladder tumor (TURBT; with or without peri-operative chemotherapy) within 60 days prior to randomization:
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Recurrence within 1 year, low-grade Ta
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Solitary low-grade Ta >3 cm
-
Low-grade Ta, multifocal
-
Solitary high-grade Ta, ≤3 cm
-
Low-grade T1
- Patients with T1 disease should undergo resection at the base of the lesion and biopsies should contain muscle fibres.
- Restage TURBT may be done at the discretion of the investigator
-
Exclusion Criteria:
- Current or previous evidence of muscle invasive (muscularis propria) or metastatic disease presented at the screening visit
High risk NMIBC defined as:
- High-grade T1
- Any recurrent, high-grade Ta
- High-grade Ta >3 cm (or multifocal)
- Any carcinoma in situ (CIS)
- Any Bacillus Calmette-Guérin (BCG) failure in high-grade subject
- Any variant histology
- Any prostatic urethral involvement
Low risk NMIBC defined as:
- First occurrence of low-grade solitary Ta ≤3 cm
- Recurrence of low-grade solitary Ta ≤3 cm >12 months from previous occurrence
- Papillary urothelial neoplasm of low malignant potential
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Arm 1 Nadofaragene Firadenovec
Participants in the nadofaragene firadenovec arm will receive quarterly instillations with nadofaragene firadenovec for 24 months. For these subjects, the disease evaluation visits will occur within 2 weeks prior to the investigation medicinal products instillation visits. |
Vector-based gene therapy for NMIBC treatment to potentiate durable therapeutic responses by interferon (IFN) alfa-2b (IFN-α2b) amplification.
Andre navne:
|
|
Ingen indgriben: Arm 2 - Observation
Subjects will be followed based on the surveillance schedule of the AUA/SUO guideline (quarterly) over the 24 months treatment period. . |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Recurrence Free survival
Tidsramme: 24 months
|
Recurrence-free survival, defined as the time from the date of randomization to the date of first documented recurrence, progression or death (due to any cause), whichever occurs first during the treatment period. |
24 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Adverse Events
Tidsramme: up to 24 months
|
Frequency and intensity of adverse events will be recorded from the signed informed consent for participation in the trial up to month 24 |
up to 24 months
|
|
Recurrence Free Survival at 12 Months
Tidsramme: 12 months
|
Recurrence free survival at 12 months defined as whether a subject is alive and is documented recurrence and progression-free for up to 12 months |
12 months
|
|
Recurrence Free Survival at 24 Months
Tidsramme: 24 Months
|
Recurrence free survival at 24 months defined as whether a subject is alive and is documented recurrence and progression-free for up to 24 months |
24 Months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Global Clinical Compliance, Ferring Pharmaceutical
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. oktober 2024
Primær færdiggørelse (Anslået)
30. september 2028
Studieafslutning (Anslået)
30. september 2032
Datoer for studieregistrering
Først indsendt
15. juli 2024
Først indsendt, der opfyldte QC-kriterier
15. juli 2024
Først opslået (Faktiske)
19. juli 2024
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
30. oktober 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
28. oktober 2026
Sidst verificeret
1. oktober 2026
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 000423
- U1111-1284-0685 (Anden identifikator: World Health Organization (UTN))
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .