Spots Global Cancer Trial Database for A Retrospective Non Interventional Study on First Line Treatment for Patients With BRAFV600E Mutant Metastatic Colorectal Cancer (mCRC)
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Trial Identification
Brief Title: A Retrospective Non Interventional Study on First Line Treatment for Patients With BRAFV600E Mutant Metastatic Colorectal Cancer (mCRC)
Official Title: A Retrospective Non Interventional Study on First Line Treatment for Patients With BRAFV600E Mutant Metastatic Colorectal Cancer (mCRC)
Study ID: NCT04317599
Interventions
Study Description
Brief Summary: The presence of a BRAFV600E mutation is considered a marker of poor prognosis in patients with mCRC, and findings from clinical trials have largely remained inconclusive regarding the efficacy of first line treatments for BRAF-mutant mCRC patients. In the absence of targeted/specific treatment for BRAF-mutant mCRC, treatment practices can vary based on local practices and guidelines. There is, therefore, an unmet need to document the current practices for first-line treatment of BRAF-mutant mCRC, and their effectiveness and safety in a real-world setting. This real-world, multicenter non-interventional study (NIS) will describe the treatment patterns, effectiveness and safety of current treatment regimens in BRAFV600E mutant mCRC patients in Europe, with the aim to put the clinical study findings of the ongoing Phase 2, single-arm, open label trial (ANCHOR) into context of the current treatment landscape excluding investigational therapies. Additionally, the NIS output may be used to support future health technology assessment submissions and publications.
Detailed Description: This retrospective, multi-center longitudinal study on BRAFV600E mutant mCRC patients will be conducted in Europe to characterize the first-line treatment patterns. All BRAFV600E mutant patients having initiated a first-line treatment for mCRC between January 1st, 2016 and December 31st, 2018 (both days inclusive) with drugs registered for mCRC in respective country will be eligible to participate. The study will not provide or recommend any treatment or procedure; all decisions regarding treatment are made at the sole discretion of the treating physician in accordance with their usual practices and all eligible patients will be considered for enrollment. The target countries for patient enrollment will include Germany, France, Italy, United Kingdom, Spain, Belgium, Austria and the Netherlands. Approximately 300 adult patients (≥18 years) from a mix of academic and non-academic sites (up to 65 sites) will be enrolled.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Barmherzige Brüder Krankenhaus St. Veit/Glan., St. Veit/Glan, , Austria
Medizinische Universität Wien, Vienna, , Austria
Imelda VZW, Bonheiden, , Belgium
AZ Klina, Brasschaat, , Belgium
UZ Leuven, Leuven, , Belgium
CHC MontLégia, Liège, , Belgium
CHRU de Besançon, Besançon, , France
GHPSO (Groupe Hospitalier Sud de l'Oise), Creil, , France
CHU Grenoble Alpes, La Tronche, , France
Hôpital Franco-Britannique, Levallois-Perret, , France
Centre Oscar Lambert, Lille, , France
ICM Val d'Aurelle, Montpellier, , France
CHU de Poitiers, Poitiers, , France
Gustave Roussy, Villejuif, , France
Klinikum Aschaffenburg Medical Klinik IV, Aschaffenburg, , Germany
Studienzentrale Gokos, Dresden, , Germany
Universitätsklinikum Essen, Essen, , Germany
Facharztzentrum Eppendorf, Hamburg, , Germany
Oncoresearch Lerchenfeld, Hamburg, , Germany
MVZ Mitte Leipzig, Leipzig, , Germany
MZ Onkologie Velbert/Ratingen/Mettmann, Velbert, , Germany
Clinica Oncologica Ospedali Riuniti di Ancona, Ancona, , Italy
Santa Maria Goretti Hospital, Latina, , Italy
Instituto Nazionale Tumori, IRCCS, Fondazione G. Pascale, Napoli, , Italy
Azienda Ospedaliero-Universitaria Pisana, Pisa, , Italy
AUSL-IRCCS of Reggio Emilia-Clinical Cancer Center, Reggio Emilia, , Italy
Asst Valle Olona, Saronno, , Italy
Hospital del Mar, Barcelona, , Spain
La Paz University Hospital, Madrid, , Spain
Hospital General Universitario de Valencia, Valence, , Spain
University Hospitals Birmingham NHS Foundation Trust, Birmingham, , United Kingdom
Harrogate & District NHS Foundation Trust, Harrogate, , United Kingdom
Imperial College Healthcare NHS Trust, London, , United Kingdom
University College London Hospitals NHS Foundation Trust, London, , United Kingdom
Contact Details
Name: Bernard Asselain, MD, PhD
Affiliation:
Role: STUDY_CHAIR
Name: Dirk Arnold, MD, PhD
Affiliation:
Role: STUDY_CHAIR
Name: Erika Martinelli, MD, PhD
Affiliation:
Role: STUDY_CHAIR
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