Clinical trial NCT01990248: An Observational Safety Study in Zelboraf (Vemurafenib)-Treated Patients With BRAF-V600 Mutation-Positive Unresectable or Metastatic Melanoma (ZeSS)
Official title: ZeSS: A Prospective Observational Safety Study of Patients With BRAF-V600 Mutation-positive Unresectable or Metastatic Melanoma Treated With Vemurafenib (Zelboraf®)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malignant Melanoma
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2013-11-21
Enrollment: 339
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with unresectable or metastatic melanoma treated with vemurafenib

Brief summary: This multi-center, prospective, observational safety study will evaluate the safety and effectiveness of Zelboraf (vemurafenib) in a real world setting. Data from Zelboraf-treated patients with BRAF-V600 mutation-positive unresectable or metastatic melanoma will be collected for 2 years.


Eligibility criteria: Inclusion Criteria:

* Adult patients of the age of 18 years or older
* Diagnosis of BRAF-V600 mutation-positive unresectable or metastatic melanoma confirmed by a validated test and being treated with vemurafenib
* Vemurafenib treatment must have been initiated at the time of enrollment or no more than one month prior to enrollment
* Patient (or legally acceptable representative) has personally signed and dated the informed consent document indicating that he or she has been informed of all pertinent aspects of the study, if applicable
* Patient is willing to provide information on at least one alternate contact person for study staff to contact regarding the patient's whereabouts, should the patient become lost to follow-up during the course of the study

Exclusion Criteria:

* Patient was treated with vemurafenib as part of a clinical trial or expanded access program
* Patient has participated in any studies involving any investigational study drug within one month prior to initiating vemurafenib treatment
* Patient has any significant history of disease of medical condition (except metastatic melanoma) which in the judgment of the investigator has the potential to impact participation on the study

Primary outcomes:
measure: Incidence of non-cutaneous squamous cell carcinoma
timeFrame: 2 years
measure: Incidence of cutaneous squamous cell carcinoma
timeFrame: 2 years
measure: Incidence of QT prolongation (defined as QTc >500 ms or an increase in QTc >60 ms)
timeFrame: 2 years
measure: Incidence of abnormal liver function
timeFrame: 2 years
Secondary outcomes:
measure: Incidence of a second (or subsequent) primary melanoma
timeFrame: 2 years
measure: Incidence of gastrointestinal polyps
timeFrame: 2 years
measure: Incidence of adverse events
timeFrame: 2 years
Other outcomes:
Locations:
city: Feldkirch
country: Austria
facility: LKH Feldkirch; Onkologie
city: Linz
country: Austria
facility: Ordensklinikum Linz Elisabethinen ; Dermatologie
city: Wien
country: Austria
facility: Krankenhaus Hietzing Wien
city: Antwerpen
country: Belgium
facility: ZNA Middelheim
city: Bruxelles
country: Belgium
facility: CHIREC Edith Cavell
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires St-Luc
city: Edegem
country: Belgium
facility: UZ Antwerpen
city: Ostrava
country: Czechia
facility: FN Ostrava; Dermatology dep
city: Praha
country: Czechia
facility: University Hospital Prague
city: Zlin
country: Czechia
facility: Komplexni onkologicke centrum Krajske nemocnice T. Bati, a.s. Zlin
city: Augsburg
country: Germany
facility: Klinikum Augsburg; Hauttumorzentrum
city: Berlin
country: Germany
facility: Charite- universitatsmedizin Berlin; Med. Klinik mit Schwerpunkt Hamatologie und Onkologie
city: Bochum
country: Germany
facility: Ruhr-Universität Bochum; Klinik für Dermatologie und Allergologie
city: Bonn
country: Germany
facility: Universitatsklinikum Bonn; Klinisches Studienzentrum Klinik fur Dermatologie
city: Bonn
country: Germany
facility: Medizinisches Zentrum
city: Buxtehude
country: Germany
facility: Dermatologisches Zentrum am Elbe Klinikum Buxtehude
city: Chemnitz
country: Germany
facility: DRK Krankenhaus Chemnitz-Rabenstein; Hautkrebszentrum Chemnitz
city: Dresden
country: Germany
facility: Universitätsklinikum "Carl Gustav Carus"; Klinik und Poliklinik fur Dermatologie
city: Düsseldorf
country: Germany
facility: Universitätsklinikum Düsseldorf; Hautklinik
city: Erfurt
country: Germany
facility: Dermatologie und Allergologie HELIOS Hauttumorzentrum Erfurt
city: Essen
country: Germany
facility: Universitatsklinikum Essen; Klinik für Dermatologie
city: Gera
country: Germany
facility: SRH Wald-Klinikum Gera; Zentrum fur klinische Studien (ZKS)
city: Greifswald
country: Germany
facility: Universitätsmedizin Greifswald; Klinik und Poliklinik für Hautkrankheiten
city: Göttingen
country: Germany
facility: Universitaetsmedizin Goettingen; Abteilung Dermato-Onkologie
city: Heidelberg
country: Germany
facility: Univ.- Hautklinik Heidelberg
city: Jena
country: Germany
facility: Friedrich-Schiller-Universitaet Jena; Klinik fuer Dermatologie und dermatologische Allergologie
city: Kassel
country: Germany
facility: Klinikum Kassel GmbH; Hauttumorzentrum HTZ
city: Leer
country: Germany
facility: Studienzentrum UnterEms; Onkologische Schwerpunktpraxis Leer; Dr. med. Lothar Müller
city: Ludwigshafen
country: Germany
facility: Klinikum der Stadt Ludwigshafen am Rhein gGmbH; Hauttumorzentrum Rheinpfalz
city: Lübeck
country: Germany
facility: UKSH Universitatsklinikum Schleswig-Holstein; Studienzentrum Dermatologie 10d
city: Mainz
country: Germany
facility: Klinik und Poliklinik fur Dermatologie; Universitatsklinikum Mainz
city: Mannheim
country: Germany
facility: Med. Fakultat Mannheim der Universitat Heidelberg; Klinik fur Dermatologie
city: Minden
country: Germany
facility: Johannes Wesling Klinikum Minden;Haut Tumor Centrum Minden
city: Muenster
country: Germany
facility: Universitätsklinikum Münster; Klinik für Hautkrankheiten; Allgemeine Dermatologie und Venerologie
city: Muenster
country: Germany
facility: Fachklinik Hornheide; Abteilung für Dermatologie
city: Nürnberg
country: Germany
facility: Klinikum Nürnberg Nord; Hautklinik; Klinik für Dermatologie
city: Quedlinburg
country: Germany
facility: Harzklinikum Dorothea Christiane Erxleben GmbH, Standort Quedlinburg; Hautkrebszentrum Harz
city: Recklinghausen
country: Germany
facility: Klinikum Vest; Behandlungszentrum Kanppschaftskrankenhaus Recklinghausen
city: Rostock
country: Germany
facility: Universitätsmedizin Rostock; Klinik und Poliklinik für Dermatologie und Venerologie
city: Tuebingen
country: Germany
facility: Eberhard-Karls-Universitat Tubingen; Sektion Dermatologische Onkologie
city: Würzburg
country: Germany
facility: Universitätsklinikum Würzburg; Klinik und Poliklinik für Dermatologie Venerologie u. Allergologie
city: Galway
country: Ireland
facility: Galway University Hospital; Clinical Trials Department
city: Napoli
country: Italy
facility: Istituto Nazionale Tumori Fondazione G. Pascale
state: Campania
city: Bologna
country: Italy
facility: Policlinico S. Orsola Malpighi;Dip. Ematologia, Oncologia e Medicina di Laboratorio
state: Emilia-Romagna
city: Faenza
country: Italy
facility: Ausl Ravenna-Osp.Infermi; Day Hospital Oncologia Medica
state: Emilia-Romagna
city: Modena
country: Italy
facility: Universita di Modena e Reggio Emilia;Dipartimento di Oncologia ed Ematologia
state: Emilia-Romagna
city: Piacenza
country: Italy
facility: Ospedale "Guglielmo da Saliceto";U.O. Medicina Oncologica
state: Emilia-Romagna
city: Rimini
country: Italy
facility: Azienda ASL di Rimini (Presidi di Rimini - Cattolica)) - Ospedale degli Infermi;U.O. Oncologia
state: Emilia-Romagna
city: Milano
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori
state: Lombardia
city: Milano
country: Italy
facility: Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia
state: Lombardia
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo, Oncologia
state: Lombardia
city: Sondrio
country: Italy
facility: A.O.V.V. - P.O. di Sondrio; S.O.C. Oncologia Medica
state: Lombardia
city: Firenze
country: Italy
facility: A.U Careggi di Firenze;Oncologia
state: Toscana
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana
state: Toscana
city: Siena
country: Italy
facility: Azienda Ospedaliera Universitaria Senese, U.O.C. Immunoterapia Oncologica
state: Toscana
city: Breda
country: Netherlands
facility: Amphia Ziekenhuis, locatie Langendijk;Oncology
city: Groningen
country: Netherlands
facility: Academ Ziekenhuis Groningen; Medical Oncology
city: Heerlen
country: Netherlands
facility: Atrium MC, Parkstad Heerlen; Poli Interne
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center,Division of Medical Oncology; Dept. Internal Medicine
city: Bydgoszcz
country: Poland
facility: Centrum Onkologii w Bydgoszczy; Oddzial Kliniczny Onkologii
city: Krakow
country: Poland
facility: Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki Onkologii
city: Lodz
country: Poland
facility: RegioNAlny Osrodek Onkologiczny Pododdział Diagnostyki i Terapii Onkologicznej
city: Lodz
country: Poland
facility: Regionalny Osrodek Onkologiczny; Oddzial Chorob Rozrostowych
city: Opole
country: Poland
facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej; Opolskie Centrum Onkologii
city: Warszawa
country: Poland
facility: Centrum Onkologii - Instytut, Klinika Nowotworow Tkanek Miekkich, Kosci i Czerniakow
city: Karlskrona
country: Sweden
facility: Blekingesjukhuset; Kirurgkliniken
city: Stockholm
country: Sweden
facility: Karolinska University Hospital;Department of Oncology-Pathology
city: Brighton
country: United Kingdom
facility: Royal Sussex County Hospital
city: Bristol
country: United Kingdom
facility: Bristol Haematology and Oncology Centre
city: Cambridge
country: United Kingdom
facility: Addenbrookes Hospital; Dept of Oncology
city: Cardiff
country: United Kingdom
facility: Velindre Cancer Centre
city: Cheltenham
country: United Kingdom
facility: Cheltenham General Hospital; Gloucestershire Oncology Centre
city: Dorchester
country: United Kingdom
facility: Dorset County Hospital NHS Foundation Trust;Research and Development/ Oncology
city: Leeds
country: United Kingdom
facility: St James University Hospital
city: London
country: United Kingdom
facility: Guys and St Thomas NHS Foundation Trust, Guys Hospital
city: London
country: United Kingdom
facility: St George's Hospital; Oncology
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust;Medical Oncology
city: St Helens
country: United Kingdom
facility: St Helens & Knowsley Trust
city: Wirral
country: United Kingdom
facility: The Clatterbridge Cancer Ctr For Oncolgy
city: Wolverhampton
country: United Kingdom
facility: New Cross Hospital; Deansley Centre
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: