MX39897: Registry in patients profiled with NGS
Research type
Research Database
IRAS ID
279177
Contact name
Olga Skatkova
Contact email
Research summary
A REGISTRY TO COLLECT CHARACTERISTICS AND OUTCOMES FROM PATIENTS WITH SOLID TUMORS PROFILED WITH A NEXT GENERATION SEQUENCING TEST (WAYFIND-R)
REC name
South West - Central Bristol Research Ethics Committee
REC reference
21/SW/0168
Date of REC Opinion
5 Jan 2022
REC opinion
Further Information Favourable Opinion
Data collection arrangements
This study is a global, prospective, non-interventional patient registry, which will collect data on patients with solid tumour cancers who are currently undergoing a variety of treatments in routine clinical care, without any intent to investigate or assess specific therapeutic products or diagnostic tests.
The aim is to create a platform to collect data on the natural history of solid tumour cancer patients, who have undergone Next-Generation Sequencing (NGS) based molecular profiling.
A wide range of data elements will be collected, including but not limited to information on patients’ socio-demographic characteristics, prior and current cancer details (e.g. type, histology, stage, date of diagnosis, remission status, family history, major diagnostic procedures, treatment and therapies).
Data from existing patient medical records will be collected at enrolment and updated prospectively at least every 6 months. Information on any visit that occurred within the 6-month intervals will be recorded at the 6-month data collection time point.
Investigational site characteristics (e.g.type of hospital and population demographics) and treating physician characteristics (e.g.physician medical specialty) will be collected at the time of the first patient enrolment.
The safety variables that will be collected include serious adverse events, adverse events that lead to treatment discontinuation and occurrence of pregnancies.Research programme
The field of precision medicine is constantly evolving with the introduction of new targeted therapies. This invokes a future call for capturing the most up-to-date data from patients who are receiving molecularly-guided treatment options (MGTO), thus making prospective and dynamic data collection crucial. MGTO is an approach that uses molecular information to guide treatment decisions based on available clinical evidence, with the aim being to tailor therapies and improve outcomes for the individual patient, taking additional patient characteristics into account. The evidence generated from high-quality real world data (RWD) would provide benefits for various stakeholders, including patients, treating physicians, regulatory authorities, researchers and the pharmaceutical industry. High-quality RW evidence could simultaneously enhance understanding of the effect of MGT on outcomes in clinical practice; help to define sub-populations that may benefit most from MG therapies; aid in the improvement of patient care by providing a better view of treatment decisions following molecular profiling, including drivers and barriers to treatment access; and support the development of treatment options for patients. The aim of this registry is to create a platform to collect data on the natural history of cancer patients who have undergone Next-Generation Sequencing (NGS) based molecular-tumour profiling. A wide range of data elements will be collected with the intention to address different types of research questions through secondary data use (SDU) studies and ancillary studies.
Research database title
A REGISTRY TO COLLECT CHARACTERISTICS AND OUTCOMES FROM PATIENTS WITH SOLID TUMORS PROFILED WITH A NEXT GENERATION SEQUENCING TEST (WAYFIND-R)
Establishment organisation
F. Hoffmann-La Roche Ltd
Establishment organisation address
Grenzacherstrasse 124,
CH-4070 Basel
Switzerland.
D-79639