Study Description
Non-interventional (observational) cohort prospective real life study with primary and
secondary data collection from patients on adjuvant treatment with dabrafenib +
trametinib in patients with completely resected high-risk stage III (stage IIIA [lymph
node > 1mm], IIIB, IIIC and IIID according to AJCC 8th edition) melanoma in Turkey. The prospective registration of completely resected high-risk stage III melanoma patients
treated with dabrafenib and trametinib in the adjuvant setting will be based on
collaboration with centers of excellence on melanoma patients treatment. Pre-identified
centers (up to 12) considered as the most advanced according to their knowledge and
experience, will take part in the patients recruitment.
Interventions
dabrafenib
trametinib
Eligibility Criteria
Inclusion Criteria:
- Patients with complete surgical resection of histologically confirmed AJCC (8th
edition) clinical stage III (stage IIIA [lymph node > 1mm],, IIIB, IIIC, IIID)
melanoma, in whom a decision for adjuvant treatment with dabrafenib and trametinib
has been made before entering the study;
- V600E mutation-positive cutaneous melanoma;
- ≥ 18 years of age;
- Written informed consent signed.
Exclusion Criteria:
- Lack of basic demographic and staging data.
- Current active participation in an interventional clinical trial for treatment of
melanoma.
- Pregnancy or breastfeeding women.
- Current primary diagnosis of a cancer other than melanoma, that requires systemic or
other treatment.
Novartis Investigative Site
Recruiting
Izmir,35040,Turkey
Novartis Investigative Site
Recruiting
Ankara,06680,Turkey
Novartis Investigative Site
Recruiting
Kecioren Ankara,06010,Turkey
Novartis Investigative Site
Recruiting
Antalya,07059,Turkey
Novartis Investigative Site
Recruiting
Diyarbakir,21000,Turkey
Novartis Investigative Site
Recruiting
Edirne,22030,Turkey
Novartis Investigative Site
Recruiting
Istanbul,34668,Turkey
Novartis Investigative Site
Recruiting
Bursa,Gorukle,16059,Turkey
Novartis Investigative Site
Recruiting
Istanbul,Turkey
Novartis Investigative Site
Recruiting
Ankara,06520,Turkey
Worldwide Contacts
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