ctDNA stands for circulating tumour DNA. As ctDNA is released by tumour cells into the blood stream, taking a blood sample and analysing it for ctDNA, can provide a lot of useful information about a patient's cancer. In certain situations, ctDNA can be used to screen for or detect cancer early, to aid clinical decisions about which treatment to give a patient, to provide information about if a cancer has become resistant to treatment, or provide information about how much cancer may be left after treatment (residual disease).
The aim of this trial is to establish the clinical utility of implementing ctDNA testing in cancer patients with a view to enhance the delivery of personalised care within the National Health Service in the United Kingdom (UK).
One hundred patients will be recruited, with 20 from each of the following cancer types:
* Non-small cell lung cancer * Gastrointestinal stromal tumours * Colorectal cancer * Biliary tract cancer * Ovarian cancer.
Patients must be aged 18 or over, must have had progressive disease whilst receiving anti-cancer treatment, and must be being treated at The Royal Marsden.
Patients will have a blood sample taken and analysed using the Marsden360 ctDNA test. The results of the test will be looked at by The Royal Marsden Genomic Tissue Advisory Board (GTAB), and for each individual patient, the GTAB will determine if having a ctDNA test helped to personalise their care by:
* Aiding the identification of a genomically-matched standard of care therapy * Aiding the identification of a genomically-matched clinical trial (based in the UK) * Offering additional prognostic information not otherwise available through standard of care testing * Negating the need for a tissue biopsy.
Age ≥18 years old
Ability to provide written informed consent
Presence of metastatic or unresectable disease
Being reviewed and treated through medical oncology service at Royal Marsden Hospital
Medically unstable to commit to sampling required for the study
ECOG performance status ≥3
Single group
Marsden360 ctDNA test and GTAB review
Diagnostic testParticipant blood samples will analysed using the Marsden360 ctDNA test. Results will subsequently be reviewed by the Royal Marsden Genomic Tumour Advisory Board (GTAB). The GTAB will use the results of the test to try to identify a genomically-matched standard of care therapy, to identify a genomically-matched clinical trial (based in the UK), to offer additional prognositc information not otherwise available through standard of case, or determine if the need for a tissue biopsy is negated.
The number (%) of patients in whom ctDNA result was deemed to be clinically useful at the time of progression on prior line of therapy
This is a composite outcome measure, where the results of ctDNA testing performed at the time of progressive disease led to at least one of the following (to be determined by the GTAB): * Identification of a genomically-matched SOC therapy, or * Identification of a genomically-matched clinical trial (based in the UK), or * Offered additional prognostic information not otherwise available through SOC, or * Negated the need for a tissue biopsy
Patients in whom ctDNA result identified a genomically-matched SOC therapy
The number (%) of patients in whom ctDNA result identified a genomically-matched SOC therapy
Patients in whom ctDNA result identified a genomically-matched clinical trial (based in the UK)
The number (%) of patients in whom ctDNA result identified a genomically-matched clinical trial (based in the UK)
Patients in whom ctDNA result offered additional prognostic information not otherwise available through SOC testing
The number (%) of patients in whom ctDNA result offered additional prognostic information not otherwise available through SOC testing
Patients in whom ctDNA result negated need for tissue biopsy
The number (%) of patients in whom ctDNA result negated need for tissue biopsy
Number of, and name of, resistance mutations pertinent to each cohort
The number (absolute value) of, and name of, resistance mutations that occur in at least 10% of participants in each cohort
Association of allelic frequency in ctDNA with tumour burden in all cohorts
The correlation of allelic frequency in ctDNA with tumour burden in all cohorts
Number of, and name of, genomic aberrations associated with therapy class in each cohort that are associated with poorer response rates and shorter PFS
The number (absolute value) of, and name of, genomic aberrations associated with therapy class in each cohort that are associated with poorer response rates and shorter PFS
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