An observational study in Metastatic Colorectal Cancer, sponsored by Royal Marsden NHS Foundation Trust. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-12-19.
Sponsored by Royal Marsden NHS Foundation Trust · Observational
PROSPECT-C is a phase II study investigating the molecular markers of response or resistance to anti-epidermal growth factor receptor (EGFR) antibodies.
Cetuximab or panitumumab are two monoclonal antibodies that are routinely offered to patients with metastatic colorectal cancer when they have no mutation in RAS genes. In Royal Marsden Hospital patients, who are refractory to all standard therapies and have metastatic colorectal cancer are offered one of these agents in third line metastatic setting. Whilst the mechanisms of response/resistance to these therapies are well studies, they are still incompletely understood. The main hypothesis of this study is that finding mechanisms of response and/or resistance by using novel techniques such as next generation sequencing (NGS) and/or digital droplet polymerase chain reaction (ddPCR) to these therapies will allow better patient selection and application of precision medicine in such patients.
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's enrollment of 47 is below the median of 250 across 1,226 observational studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Royal Marsden NHS Foundation Trust is the lead sponsor of 262 studies on the registry; 49 are open to participants now.
Counted across the registry records on this site, refreshed daily.
patients with a histologically confirmed diagnosis of metastatic colorectal adenocarcinoma
Exclusion Criteria:
All patients will be treated with cetuximab 500mg/m2 every 2 weeks until the time of progression
Drug: Cetuximab
All patients will be offered cetuximab 500mg/m2 every 2 weeks, until the time of progression
Track and validate specific known mechanisms of resistance/response to anti-EGFR therapies through
digital droplet polymerase chain reaction (ddPCR) and ultra deep next generation sequencing (NGS) analyses of circulating tumour deoxyribonucleic acid (ct-DNA) obtained every 4 weeks during the course of treatment. Mutations found in ctDNA will also be analysed in the archival and fresh tissue specimens, used for diagnostic testing and obtained during the study respectively
Time frame: 3-4 years
Identify novel biomarkers of resistance to anti-EGFR therapies through whole exome sequencing
DNA extracted from pre- and post-treatment metastatic colorectal cancer (mCRC) biopsies; Ultra deep targeted sequencing of tumour samples and of ctDNA will be used to assess whether the identified resistance biomarkers are detectable in some patients before treatment initiation and whether this correlates with short progression free survival (PFS) and poor radiological response
Time frame: 3-4 years
This study is completed, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.
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Royal Marsden NHS Foundation Trust