An observational study in Cancer, sponsored by University of Leicester. Active, not recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-10.
Sponsored by University of Leicester · Observational
The NHS' Genomic Medicine Service offers whole genome sequencing as part of the drive to improve cancer outcomes. It is recognised that actionable mutations (current and emerging), will ultimately improve outcomes across multiple disease sites by identifying which treatments may benefit individual patients the most, and by providing earlier and more accurate diagnoses. However, testing in the cancer setting is currently limited to haematological malignancies and sarcoma. The majority of patients with solid tumours do not yet have access to this platform and the benefits that it may bring. Therefore, expanding genomic testing capacity within a research setting has potential to benefit those patients that would otherwise not be able to access testing. In this study we will be using tissue derived from patients undergoing surgery for cancer to validate an in-house genomic testing platform against Roche's Foundation Medicine genomic profile service, which is an FDA- approved commercial platform.
In addition, two blood samples will be taken in order that we can test whether markers present in the tissue may also be seen in blood. We hope that this will help us monitor minimal residual disease in patients, allowing earlier detection of relapse/recurrence than radiology currently allows.
Patients may also agree to donate optional excess fresh tissue from their surgery. This will be integrated with other laboratory platforms which may offer information on prospective drug response based on genotypic profiles (e.g., patient-derived explants).
263 studies on the registry are indexed under Neoplasm, Residual; 120 are open to participants now.
This study's planned enrollment of 20 is below the median of 100 across 86 observational studies indexed under Neoplasm, Residual.
Browse Neoplasm, Residual studies →University of Leicester is the lead sponsor of 166 studies on the registry; 51 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Trial participants will consist of patients with solid tumours that have a high likelihood of rapid post-surgical relapse. Such tumours types typically include gastroesophageal, gastrointestinal cancers and colorectal liver metastases, but other malignancies will also be considered.
Exclusion Criteria:
Cross-validate the in-house genetic testing platform against the FDA approved Foundation Medicine
To cross-validate the Thermofisher Oncomine tissue and cfTNA assays (in house) against the FDA approved Foundation Medicine platform by comparison of the spectrum and variant frequency of cancer-specific alterations detected in matched tissue and blood.
Time frame: 12-24 months
Assess Utility in detecting minimal residual disease
To compare ctDNA mutations and variant frequency in blood samples pre- and post-surgery to assess utility in detection of minimal residual disease
Time frame: 12-24 months
Data integration
Ability to integrate data from clinical risk factors, and up-front genotyping.
Time frame: 12-24 months
Feasibility of testing platform in clinical setting
Feasibility of returning laboratory analysis in a clinically meaningful timeframe.
Time frame: 12-24 months
This study is active, not recruiting, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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University of Leicester