An Observational Safety Study in Zelboraf (Vemurafenib)-Treated Patients With BRAF-V600 Mutation-Positive Unresectable or Metastatic Melanoma (ZeSS)
ZeSS: A Prospective Observational Safety Study of Patients With BRAF-V600 Mutation-positive Unresectable or Metastatic Melanoma Treated With Vemurafenib (Zelboraf®)
1 other identifier
observational
339
10 countries
80
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2013
Typical duration for all trials
80 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 23, 2013
CompletedFirst Submitted
Initial submission to the registry
November 15, 2013
CompletedFirst Posted
Study publicly available on registry
November 21, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 26, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 26, 2016
CompletedJune 19, 2018
June 1, 2018
3.3 years
November 15, 2013
June 18, 2018
Conditions
Outcome Measures
Primary Outcomes (4)
Incidence of non-cutaneous squamous cell carcinoma
2 years
Incidence of cutaneous squamous cell carcinoma
2 years
Incidence of QT prolongation (defined as QTc >500 ms or an increase in QTc >60 ms)
2 years
Incidence of abnormal liver function
2 years
Secondary Outcomes (3)
Incidence of a second (or subsequent) primary melanoma
2 years
Incidence of gastrointestinal polyps
2 years
Incidence of adverse events
2 years
Study Arms (1)
Cohort
Eligibility Criteria
Patients with unresectable or metastatic melanoma treated with vemurafenib
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (80)
LKH Feldkirch; Onkologie
Feldkirch, 6800, Austria
Ordensklinikum Linz Elisabethinen ; Dermatologie
Linz, 4020, Austria
Krankenhaus Hietzing Wien
Vienna, 1130, Austria
ZNA Middelheim
Antwerp, 2020, Belgium
CHIREC Edith Cavell
Brussels, 1180, Belgium
Cliniques Universitaires St-Luc
Brussels, 1200, Belgium
UZ Antwerpen
Edegem, 2650, Belgium
FN Ostrava; Dermatology dep
Ostrava, 708 52, Czechia
University Hospital Prague
Prague, 150 06, Czechia
Komplexni onkologicke centrum Krajske nemocnice T. Bati, a.s. Zlin
Zlín, 760 01, Czechia
Klinikum Augsburg; Hauttumorzentrum
Augsburg, 86179, Germany
Charite- universitatsmedizin Berlin; Med. Klinik mit Schwerpunkt Hamatologie und Onkologie
Berlin, 12200, Germany
Ruhr-Universität Bochum; Klinik für Dermatologie und Allergologie
Bochum, 44791, Germany
Universitatsklinikum Bonn; Klinisches Studienzentrum Klinik fur Dermatologie
Bonn, 53105, Germany
Medizinisches Zentrum
Bonn, 53111, Germany
Dermatologisches Zentrum am Elbe Klinikum Buxtehude
Buxtehude, 21614, Germany
DRK Krankenhaus Chemnitz-Rabenstein; Hautkrebszentrum Chemnitz
Chemnitz, 09117, Germany
Universitätsklinikum "Carl Gustav Carus"; Klinik und Poliklinik fur Dermatologie
Dresden, 01307, Germany
Universitätsklinikum Düsseldorf; Hautklinik
Düsseldorf, 40225, Germany
Dermatologie und Allergologie HELIOS Hauttumorzentrum Erfurt
Erfurt, 99089, Germany
Universitatsklinikum Essen; Klinik für Dermatologie
Essen, 45147, Germany
SRH Wald-Klinikum Gera; Zentrum fur klinische Studien (ZKS)
Gera, 07548, Germany
Universitaetsmedizin Goettingen; Abteilung Dermato-Onkologie
Göttingen, 37075, Germany
Universitätsmedizin Greifswald; Klinik und Poliklinik für Hautkrankheiten
Greifswald, 17487, Germany
Univ.- Hautklinik Heidelberg
Heidelberg, 69115, Germany
Friedrich-Schiller-Universitaet Jena; Klinik fuer Dermatologie und dermatologische Allergologie
Jena, 07743, Germany
Klinikum Kassel GmbH; Hauttumorzentrum HTZ
Kassel, 34125, Germany
Studienzentrum UnterEms; Onkologische Schwerpunktpraxis Leer; Dr. med. Lothar Müller
Leer, 26789, Germany
Klinikum der Stadt Ludwigshafen am Rhein gGmbH; Hauttumorzentrum Rheinpfalz
Ludwigshafen, 67063, Germany
UKSH Universitatsklinikum Schleswig-Holstein; Studienzentrum Dermatologie 10d
Lübeck, 23538, Germany
Klinik und Poliklinik fur Dermatologie; Universitatsklinikum Mainz
Mainz, 55131, Germany
Med. Fakultat Mannheim der Universitat Heidelberg; Klinik fur Dermatologie
Mannheim, 68167, Germany
Johannes Wesling Klinikum Minden;Haut Tumor Centrum Minden
Minden, 32429, Germany
Universitätsklinikum Münster; Klinik für Hautkrankheiten; Allgemeine Dermatologie und Venerologie
Münster, 48149, Germany
Fachklinik Hornheide; Abteilung für Dermatologie
Münster, 48157, Germany
Klinikum Nürnberg Nord; Hautklinik; Klinik für Dermatologie
Nuremberg, 90419, Germany
Harzklinikum Dorothea Christiane Erxleben GmbH, Standort Quedlinburg; Hautkrebszentrum Harz
Quedlinburg, 06484, Germany
Klinikum Vest; Behandlungszentrum Kanppschaftskrankenhaus Recklinghausen
Recklinghausen, 45657, Germany
Universitätsmedizin Rostock; Klinik und Poliklinik für Dermatologie und Venerologie
Rostock, 18057, Germany
Eberhard-Karls-Universitat Tubingen; Sektion Dermatologische Onkologie
Tübingen, 72076, Germany
Universitätsklinikum Würzburg; Klinik und Poliklinik für Dermatologie Venerologie u. Allergologie
Würzburg, 97080, Germany
Galway University Hospital; Clinical Trials Department
Galway, Ireland
Istituto Nazionale Tumori Fondazione G. Pascale
Napoli, Campania, 80131, Italy
Policlinico S. Orsola Malpighi;Dip. Ematologia, Oncologia e Medicina di Laboratorio
Bologna, Emilia-Romagna, 40138, Italy
Ausl Ravenna-Osp.Infermi; Day Hospital Oncologia Medica
Faenza, Emilia-Romagna, 48018, Italy
Universita di Modena e Reggio Emilia;Dipartimento di Oncologia ed Ematologia
Modena, Emilia-Romagna, 41100, Italy
Ospedale "Guglielmo da Saliceto";U.O. Medicina Oncologica
Piacenza, Emilia-Romagna, 29121, Italy
Azienda ASL di Rimini (Presidi di Rimini - Cattolica)) - Ospedale degli Infermi;U.O. Oncologia
Rimini, Emilia-Romagna, 47922, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Lombardy, 20133, Italy
Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia
Milan, Lombardy, 20162, Italy
Fondazione IRCCS Policlinico San Matteo, Oncologia
Pavia, Lombardy, 27100, Italy
A.O.V.V. - P.O. di Sondrio; S.O.C. Oncologia Medica
Sondrio, Lombardy, 23100, Italy
A.U Careggi di Firenze;Oncologia
Florence, Tuscany, 50134, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, Tuscany, 56100, Italy
Azienda Ospedaliera Universitaria Senese, U.O.C. Immunoterapia Oncologica
Siena, Tuscany, 53100, Italy
Amphia Ziekenhuis, locatie Langendijk;Oncology
Breda, 4819 EV, Netherlands
Academ Ziekenhuis Groningen; Medical Oncology
Groningen, 9713 GZ, Netherlands
Atrium MC, Parkstad Heerlen; Poli Interne
Heerlen, 6419 PC, Netherlands
Maastricht University Medical Center,Division of Medical Oncology; Dept. Internal Medicine
Maastricht, 6229 HX, Netherlands
Centrum Onkologii w Bydgoszczy; Oddzial Kliniczny Onkologii
Bydgoszcz, 85-796, Poland
Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki Onkologii
Krakow, 31-531, Poland
RegioNAlny Osrodek Onkologiczny Pododdział Diagnostyki i Terapii Onkologicznej
Lodz, 93-513, Poland
Regionalny Osrodek Onkologiczny; Oddzial Chorob Rozrostowych
Lodz, 93-513, Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej; Opolskie Centrum Onkologii
Opole, 45-060, Poland
Centrum Onkologii - Instytut, Klinika Nowotworow Tkanek Miekkich, Kosci i Czerniakow
Warsaw, 02-781, Poland
Blekingesjukhuset; Kirurgkliniken
Karlskrona, 371 85, Sweden
Karolinska University Hospital;Department of Oncology-Pathology
Stockholm, 17176, Sweden
Royal Sussex County Hospital
Brighton, BN2 5BE, United Kingdom
Bristol Haematology and Oncology Centre
Bristol, BS2 8ED, United Kingdom
Addenbrookes Hospital; Dept of Oncology
Cambridge, CB2 2QQ, United Kingdom
Velindre Cancer Centre
Cardiff, CF14 2TL, United Kingdom
Cheltenham General Hospital; Gloucestershire Oncology Centre
Cheltenham, GL53 7AN, United Kingdom
Dorset County Hospital NHS Foundation Trust;Research and Development/ Oncology
Dorchester, DT1 2JY, United Kingdom
St James University Hospital
Leeds, LS9 7TF, United Kingdom
Guys and St Thomas NHS Foundation Trust, Guys Hospital
London, SE1 9RT, United Kingdom
St George's Hospital; Oncology
London, SW17 0QT, United Kingdom
Imperial College Healthcare NHS Trust;Medical Oncology
London, W6 8RF, United Kingdom
The Clatterbridge Cancer Ctr For Oncolgy
Metropolitan Borough of Wirral, CH63 4JY, United Kingdom
St Helens & Knowsley Trust
St Helens, WA9 3DA, United Kingdom
New Cross Hospital; Deansley Centre
Wolverhampton, WV10 0QP, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 15, 2013
First Posted
November 21, 2013
Study Start
March 23, 2013
Primary Completion
July 26, 2016
Study Completion
July 26, 2016
Last Updated
June 19, 2018
Record last verified: 2018-06