Met Non Small Cell Cancer Registry (MOMENT)

Официальное название

Disease Registry on Patients With Advanced NSCLC Harboring METex14 Skipping Alterations (MOMENT)

Обзор

The purpose of this multi-national disease registry is to collect prospectively (with longitudinal follow-up) high-quality, standardized, and contemporaneous data to capture changes in the non-small cell lung cancer (NSCLC) treatment landscape and outcomes over time. The registry will capture data on participants; demographic, clinical characteristics (including biomarker data), treatment patterns, and effectiveness and safety outcomes for advanced NSCLC with mesenchymal-epithelial transition exon 14(METex14) participants treated with systemic therapy.

Подробное описание

This is a disease registry, which is an organized system using non-interventional methods to collect data on a patient population defined by a particular disease, exposure, or condition, and which is followed over time. Non-interventional means that after participants enrollment, participants will be treated according to the routine clinical treatment decision by the physician. The registry will not impose any treatment or procedure for participants.

Первичные конечные точки

• Best Overall Response (BOR) [Срок оценки: Through study completion, up to approximately 4.9 years]
• Tumor Response According to Response Evaluation Criteria in Solid Tumors Version (RECIST) 1.1 [Срок оценки: Up to approximately 4.9 years]
• Overall Survival (OS) [Срок оценки: Through study completion, up to approximately 4.9 years]
• Number of Participants with Adverse Events (AEs) [Срок оценки: Up to approximately 4.9 years]
• Number of Participants with Adverse Reactions (ARs) [Срок оценки: Up to approximately 4.9 years]

Критерии участия

Критерии включения

• Participants who signed ICF
• Participants with advanced stage (stages IIIB-IV) NSCLC (all histologies) and Confirmed METex14 skipping alterations (by valid assay)
• Participants who are starting or are already being treated with systemic therapy

Критерии исключения

• Participants who are enrolled in a clinical trial

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

Великобритания · 10 центров

• Huddersfield Royal Infirmary — Huddersfield
• Bedford General Hospital — Bedford
• Birmingham Heartlands Hospital — Birmingham
• Royal Bournemouth Hospital — Bournemouth
• The Royal Marsden Hospital — Chelsea
• Northwick Park Hospital — Harrow
• Clatterbridge Cancer Centre - Liverpool — Liverpool
• Guy's Cancer Centre — London
• … и ещё 2 центра

Испания · 9 центров

• Clinica Tres Torres — Barcelona
• Institut Universitari Dexeus-Quiron - Servei d oncologia medica - Institut Oncologic Dr. R — Barcelona
• Complejo Hospitalario Universitario Insular-Materno Infantil — Las Palmas de Gran Canaria
• Centro Integral Oncologico Clara Campa — Madrid
• Centro Oncologico MD Anderson — Madrid
• Hospital Regional Universitario de Malaga - Hospital General — Málaga
• Hospidal Universitario Ntra. Sra. De Valme — Seville
• Hospital Universitario Virgen Macarena — Seville
• … и ещё 1 центр

Франция · 8 центров

• Centre Hospitalier de Cholet — Cholet
• CHRU Lille — Lille
• Hôpital du Scorff — Lorient
• Centre Leon Berard — Lyon
• Hospital Tenon & University Paris 6 — Paris
• Institut Curie - Centre de Lutte Contre le Cancer (CLCC) — Paris
• CHU de Pontchaillou — Rennes
• CHU de Toulouse Hopital Larrey — Toulouse

Израиль · 8 центров

• Haemek Medical Center — Afula
• Bnei-Zion Medical Center — Haifa
• Carmel Medical Center — Haifa
• Rambam Medical Center - PPDS — Haifa
• Shaare Zedek Medical Center — Jerusalem
• Rabin Medical Center Oncology Beilinson Campus — Petah Tikva
• Chaim Sheba Medical Center — Ramat Gan
• Tel Aviv Sourasky Medical Center — Tel Aviv

Италия · 8 центров

• Istituto Europeo di Oncologia — Milan
• Istituto Nazionale Dei Tumori — Milan
• Azienda Ospedaliero Universitaria di Modena — Modena
• Azienda Ospedaliera Dei Colli - Ospedale Monaldi — Naples
• AOU dell'Università degli Studi della Campania Luigi Vanvitelli — Naples
• I.F.O. Istituto Nazionale Tumori Regina Elena IRCCS — Rome
• Azienda Sanitaria Ospedaliera S Luigi Gonzaga — Torino
• Ospedale di Circolo — Varese

Германия · 4 центра

• Klinikum Chemnitz GmbH — Chemnitz
• KKH Grosshansdorf GmbH — Großhansdorf
• Thoraxklinik-Heidelberg gGmbH — Heidelberg
• Klinik Löwenstein GmbH — Löwenstein

США · 3 центра

• Holy Cross Health — Fort Lauderdale
• The Ohio State University Wexner Medical Center — Columbus
• Vanderbilt University Medical Center — Nashville

Канада · 3 центра

• Ottawa Hospital General Campus — Ottawa
• Princess Margaret Cancer Centre — Toronto
• British Columbia Cancer Agency (6864) — Vancouver

Нидерланды · 3 центра

• VU Medisch Centrum — Amsterdam
• Universitair Medisch Centrum Groningen - Department of Medical Oncology — Groningen
• Leiden University Medical Center — Leiden

Португалия · 3 центра

• Centro Hospitalar de Lisboa Norte, EPE - Hospital de Santa Maria — Lisbon
• Centro Hospitalar do Porto E.P.E. Hospital de Santo António — Porto
• Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe - PPDS — Porto Covo

Австрия · 2 центра

• Klinikum Klagenfurt Am Woerthersee — Klagenfurt
• Klinik Floridsdorf — Vienna

Бельгия · 2 центра

• AZ Delta — Roeselare
• AZ Nikolaas — Sint-Niklaas

Чехия · 2 центра

• FN Olomouc — Olomouc
• University Hospital Na Bulovce — Prague

Швеция · 1 центр

• Universitetssjukhuset i Linköping — Linköping

Публикации

• Thomas M, Christopoulos P, Iams WT, Mazieres J, Cortot AB, Peled N, Minuti G, Smit EF, Audhuy F, Berghoff K, Eggleton SP, Fries F, Hildenbrand M, Liu P, Mahmoudpour SH, Menzel C, Oksen D. MOMENT registry: Patients with advanced non-small-cell lung cancer harboring MET exon 14 skipping treated with systemic therapy. J Comp Eff Res. 2025 Feb;14(2):e240127. doi: 10.57264/cer-2024-0127. Epub 2025 Jan PMID 39836056

Идентификаторы

NCT: NCT05376891 · MS200095_0050

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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