Assessment of Tumour Tissue with Advanced or Metastatic Malignancies
Research type
Research Study
Full title
A Non interventional Biomarker Study on the Molecular Evaluation of Archival Tumor Tissue in Subjects with Advanced or Metastatic Malignancies
IRAS ID
346122
Contact name
Anna Minchom
Contact email
Sponsor organisation
Amgen Ltd
Duration of Study in the UK
1 years, 4 months, 29 days
Research summary
Cancer is a major public health problem worldwide and it is predicted there will be 28 million new cancer cases worldwide each year by 2040. Delays in diagnosis and treatment may lead to an increase in severe cancer cases and deaths. Therefore, this study is being done to find out more about advanced or metastatic malignancies (cancer that has spread from where it started to another part of the body). This study aims to characterize the changes to the genetic make-up that may be medically significant within tumors in subjects over the age of 18 with advanced or metastatic cancer. In particular, this study will look for the presence of a gene called MTAP in patients, which holds the instructions for making a protein called methylthioadenosine phosphorylase. Tumors that have the MTAP gene deleted are a promising target for anti-cancer drugs. Therefore, the information from this study might help find more treatments in the future for advanced or metastatic cancers. No study drug is being tested in this study, meaning patients will not directly benefit from taking part. Tumor tissue samples, taken from patients within the last five years, will be analysed using a diagnostic test called FoundationOne Companion Diagnostic (F1CDx). F1CDx is a laboratory test known as next generation sequencing that can detect genetic changes within tumours. About 1500 people will take part in this study, out of which about 36 will be from the UK. This study will take place in up to 150 hospitals in Australia, Belgium, Brazil, Canada, Czech Republic, France, Germany, Greece, Hong Kong, Hungary, Italy, Japan, Latvia, Netherlands, Poland, Portugal, Singapore, South Korea, Spain, Switzerland, Taiwan, Turkey, United Kingdom and United States. The study will enrol patients until approximately February 2026 and the results will help doctors understand more about cancer and its treatments.
REC name
West Midlands - Solihull Research Ethics Committee
REC reference
24/WM/0153
Date of REC Opinion
13 Sep 2024
REC opinion
Further Information Favourable Opinion