NEOlung
Research type
Research Study
Full title
NEOlung—A non-randomized performance evaluation study assessing the molecular diagnostic tests NEOliquid and NEOplus \nin lung-cancer patients\nA post-marketing clinical evaluation\n
IRAS ID
210692
Contact name
Martin Foster
Contact email
Sponsor organisation
NEO New Oncology GmbH
Duration of Study in the UK
1 years, 0 months, 31 days
Research summary
The present study is a post-marketing study, i.e., a study which is conducted to collect more information on a medicinal product after its approval and release on the market. The study is designed to evaluate the in-vitro diagnostic devices “NEOliquid onsite” and “NEOplus onsite” (below shortly NEOliquid/NEOplus). \nIn-vitro diagnostic devices are used to analyse samples originating from the human body. The NEO assays detect therapy-relevant gene alterations within blood and tissue tumour samples. In the present study these assays will be evaluated in the detection of somatic mutations, i.e. acquired alterations in DNA that occur after conception, in the samples of patients suffering from a special form of lung cancer (non-squamous, non-small cell lung cancer; NSCLC).\nPatients are directly involved in study procedures only once (Visit 1: blood collection and documentation of baseline data).\n
REC name
London - South East Research Ethics Committee
REC reference
17/LO/1861
Date of REC Opinion
4 Jan 2018
REC opinion
Further Information Favourable Opinion