Disease Registry on Patients with Advanced NSCLC
Research type
Research Database
IRAS ID
311885
Contact name
Shobhit Baijal
Contact email
Research summary
Disease Registry on Patients with Advanced Non-small Cell Lung Cancer (NSCLC) Harboring METex14 Skipping Alterations / MOMENT ((Met nOn sMall cEll caNcer regisTry))
REC name
West of Scotland REC 5
REC reference
22/WS/0135
Date of REC Opinion
27 Oct 2022
REC opinion
Further Information Favourable Opinion
Data collection arrangements
People will be invited to participate in the registry and will be asked to sign an informed consent form. If they agree to participate, the following information will be collected: personal information, complete medical history, results of tests performed as part of routine care for management of NSCLC, and therapies received during the registry. Additionally, tumour images will be collected and available samples from previous tissue or liquid biopsies will be sent to a central laboratory for re-testing. There will be no change to the routine medical care for people that participate in the registry.
Data will be collected from medical records of people from the start of data collection (date of the first person inclusion) until the end of a 5-year period. Hence, the total duration of data collection will be at least 5 years. People will be enrolled in the registry up to 4.5 years, allowing them to be enrolled until 6 months prior to the end of the data collection, which will therefore allow at least 6-month follow-up time for the last person enrolled.
Research programme
The purpose of this disease registry is to collect data on people who have advanced non-small cell lung cancer (NSCLC) with the genetic defect called ‘METex14 skipping alterations’ and are being treated with currently approved anti-cancer therapies. This registry aims to collect data on current treatment options, how effective these treatments are, and their overall safety outcomes. Data will be stored in the registry database and used for future research studies to better understand rare diseases like this specific type of advanced NSCLC. This study is sponsored by Merck Healthcare KGaA. Approximately 700 people with advanced NSCLC having METex14 skipping alterations will participate in this registry from more than 50 sites across Europe and North America.
Research database title
Disease Registry on Patients with Advanced Non-small Cell Lung Cancer (NSCLC) Harboring METex14 Skipping Alterations / MOMENT ((Met nOn sMall cEll caNcer regisTry))
Establishment organisation
cisiv
Establishment organisation address
12th Floor CI Tower
St George's Square
New Malden
KT3 4HG