An Observational Study of BRAF Inhibitors Effectiveness in Patients With Newly Diagnosed Metastatic Melanoma

NCT ID: NCT02143999

Last Updated: 2017-06-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

403 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-06-27

Study Completion Date

2016-12-30

Brief Summary

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This observational study will evaluate the effectiveness of BRAF inhibitors and current therapies in patients with newly diagnosed metastatic melanoma with or without BRAF V600 mutation. Patients will be treated per the locally approved therapeutic options in clinical practice. The observation period for each patient will be up to 24 months.

Detailed Description

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Conditions

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Malignant Melanoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Adult patients, \>/= 18 years of age at diagnosis
* Histologically confirmed new diagnosis of unresectable or metastatic melanoma
* Patients with tumor samples available for assessment of BRAF V600 mutation

Exclusion Criteria

* Prior systemic therapy for metastatic disease
* Participation in interventional clinical trials
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Policlinico Ospedaliero Ss Annunziata; U.O. Di Clinica Oncologica

Chieti, Abruzzo, Italy

Site Status

Istituto Tumori Giovanni Paolo II IRCCS Ospedale Oncologico Bari

Bari, Apulia, Italy

Site Status

IRCCS IST. Tumori Fondaz. Pascale; S.C. Oncologia Medica,Melanoma,Immunoterapia E Terapie Innovative

Napoli, Campania, Italy

Site Status

Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica

Bologna, Emilia-Romagna, Italy

Site Status

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST);U.O. di Immunoterapia

Meldola, Emilia-Romagna, Italy

Site Status

Arcispedale Santa Maria Nuova; Oncologia

Reggio Emilia, Emilia-Romagna, Italy

Site Status

Policlinico Universitario Campus Biomedico; Uoc Oncologia Medica

Rome, Lazio, Italy

Site Status

Policlinico Umberto i di Roma; dip. Scienze Radiologiche, Oncologiche, Anatomopatologiche

Rome, Lazio, Italy

Site Status

IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST); Oncologia Medica A

Genoa, Liguria, Italy

Site Status

Asst Papa Giovanni XXIII; Oncologia Medica

Bergamo, Lombardy, Italy

Site Status

Az. Osp. Spedali Civili; Divisione Di Oncologia - Iii Medicina

Brescia, Lombardy, Italy

Site Status

Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2

Milan, Lombardy, Italy

Site Status

Irccs Istituto Europeo Di Oncologia (Ieo); Unita' Di Ricerca Traslazionale Del Melanoma

Milan, Lombardy, Italy

Site Status

Fondazione Del Piemonte Per L'oncologia IRCC Di Candiolo

Candiolo, Piedmont, Italy

Site Status

Azienda Sanitaria Ospedaliera s. Croce e Carle; Oncologia Medica

Cuneo, Piedmont, Italy

Site Status

Ospedale Maggiore Della Carita; Oncologia Medica

Novara, Piedmont, Italy

Site Status

Azienda Ospedaliera Città della Salute e della Scienza di Torino

Turin, Piedmont, Italy

Site Status

Policlinico P. Giaccone; Istituto Di Oncologia, Clinica Medica 1

Palermo, Sicily, Italy

Site Status

Ospedale S. Vincenzo; Oncologia Medica

Taormina, Sicily, Italy

Site Status

Azienda Sanitaria di Firenze Presidio Palagi - SC Dermatologia II e Fisioterapia Dermatologica

Florence, Tuscany, Italy

Site Status

Azlenda Ospendaliero-Universitaria Pisana; C.O. Oncologia 2

Pisa, Tuscany, Italy

Site Status

Azienda Ospedaliera Universitaria Senese, U.O.C. Immunoterapia Oncologica

Siena, Tuscany, Italy

Site Status

Azienda Ospedaliero Universitaria di Ferrara - U.O. Di Oncologia

Cona (FE), Veneto, Italy

Site Status

Azienda Ospedaliera di Verona-Policlinico G.B. Rossi; Oncologia Medica

Verona, Veneto, Italy

Site Status

Countries

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Italy

Other Identifiers

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ML29031

Identifier Type: -

Identifier Source: org_study_id

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