Recruitment

Recruitment Status
Completed
Estimated Enrollment
400

Inclusion Criterias

Diagnosis of BRAF-V600 mutation-positive unresectable or metastatic melanoma confirmed by a validated test and being treated with vemurafenib
Adult patients of the age of 18 years or older
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
...
Diagnosis of BRAF-V600 mutation-positive unresectable or metastatic melanoma confirmed by a validated test and being treated with vemurafenib
Adult patients of the age of 18 years or older
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
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

Exclusion Criterias

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
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

Summary

Conditions
Malignant Melanoma
Type
Observational
Design
  • Observational Model: Cohort
  • Time Perspective: Prospective

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Inclusion Criterias

Diagnosis of BRAF-V600 mutation-positive unresectable or metastatic melanoma confirmed by a validated test and being treated with vemurafenib
Adult patients of the age of 18 years or older
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
...
Diagnosis of BRAF-V600 mutation-positive unresectable or metastatic melanoma confirmed by a validated test and being treated with vemurafenib
Adult patients of the age of 18 years or older
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
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

Exclusion Criterias

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
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

Locations

Milano, Lombardia, 20133
Dresden, 01307
Lübeck, 23538
Wirral, CH63 4JY
Cheltenham, GL53 7AN
...
Milano, Lombardia, 20133
Dresden, 01307
Lübeck, 23538
Wirral, CH63 4JY
Cheltenham, GL53 7AN
Muenster, 48157
Mainz, 55131
Bristol, BS2 8ED
Recklinghausen, 45657
Sondrio, Lombardia, 23100
Rostock, 18057
Piacenza, Emilia-Romagna, 29121
Minden, 32429
Bruxelles, 1200
Cardiff, CF14 2TL
Erfurt, 99089
Tuebingen, 72076
Brighton, BN2 5BE
Chemnitz, 09117
Würzburg, 97080
Muenster, 48149
London, SW17 0QT
Zlin, 760 01
St Helens, WA9 3DA
Maastricht, 6229 HX
Dorchester, DT1 2JY
Warszawa, 02-781
Praha, 150 06
Bologna, Emilia-Romagna, 40138
Greifswald, 17487
Lodz, 93-513
Siena, Toscana, 53100
Leer, 26789
Nürnberg, 90419
Edegem, 2650
Berlin, 12200
Modena, Emilia-Romagna, 41100
Breda, 4819 EV
Groningen, 9713 GZ
Bonn, 53111
Firenze, Toscana, 50134
Lodz, 93-513
Rimini, Emilia-Romagna, 47922
Essen, 45147
Bochum, 44791
Augsburg, 86179
Wien, 1130
Göttingen, 37075
Stockholm, 17176
Cambridge, CB2 2QQ
Bonn, 53105
London, W6 8RF
Düsseldorf, 40225
Linz, 4020
Milano, Lombardia, 20162
Karlskrona, 371 85
Pavia, Lombardia, 27100
London, SE1 9RT
Jena, 07743
Napoli, Campania, 80131
Galway
Quedlinburg, 06484
Buxtehude, 21614
Mannheim, 68167
Feldkirch, 6800
Ludwigshafen, 67063
Heerlen, 6419 PC
Antwerpen, 2020
Gera, 07548
Ostrava, 708 52
Faenza, Emilia-Romagna, 48018
Kassel, 34125
Heidelberg, 69115
Opole, 45-060
Bydgoszcz, 85-796
Wolverhampton, WV10 0QP
Leeds, LS9 7TF
Bruxelles, 1180
Pisa, Toscana, 56100
Krakow, 31-531

Tracking Information

NCT #
NCT01990248
Collaborators
Not Provided
Investigators
Study Director: Clinical Trials Hoffmann-La Roche