The GENERATE study
Research type
Research Study
Full title
Observational study on Global trEatmeNt pattERns, resource utilization, biomarker testing, and outcomes of metastatic gAsTric cancEr patients. The GENERATE study
IRAS ID
217922
Contact name
Ian Chau
Contact email
Sponsor organisation
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Clinicaltrials.gov Identifier
4525, VEAP; 32106, NIHR
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
This retrospective, observational study will collect data from approximately 100 adult patients per country
who had been diagnosed with metastatic or unresectable gastric or gastroesophageal junction GEJ
adenocarcinoma and initiated second line therapy between January 2013 and July 2015.
There are clear therapeutic guidelines for first line treatment in GEJ adenocarcinoma metastatic patients,
but there is no global clinical standard of care for second-line treatment leading to high unmet need in
terms of mortality and morbidity, especially from a real-world perspective. In addition, there is no global
data on health care resource utilization (HCRU) associated with the disease. The aim will be to
characterise the stage of the disease at the time of the second line therapy, to describe the therapy and
evaluate the disease progression, and to measure as well the HCRU and the impacts for the patients and
the community.REC name
London - Surrey Borders Research Ethics Committee
REC reference
17/LO/0443
Date of REC Opinion
11 Apr 2017
REC opinion
Further Information Favourable Opinion