An interventional study of Marsden360 ctDNA test and GTAB review in Non Small Cell Lung Cancer, Gastrointestinal Stromal Tumor (GIST) and Colorectal Cancer, sponsored by Royal Marsden NHS Foundation Trust. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-29.
Sponsored by Royal Marsden NHS Foundation Trust · Not applicable, Interventional, and Treatment
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:
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:
7,620 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,838 are open to participants now.
This study's planned enrollment of 100 is above the median of 62 across 6,019 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →Royal Marsden NHS Foundation Trust is the lead sponsor of 273 studies on the registry; 53 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
All cohorts:
Cohort 1: Locally Advanced/Metastatic NSCLC
Cohort 2: Locally Advanced/Metastatic GIST
Cohort 3: Metastatic Colorectal Cancer
Cohort 4: Locally Advanced/Metastatic BTC
Cohort 5: Advanced/Metastatic ovarian cancer
Exclusion Criteria
All cohorts:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HER2
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Diagnostic Test: Marsden360 ctDNA test and GTAB review
Participant 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
Time frame: From the date of enrolment plus 6 weeks
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
Time frame: From the date of enrolment plus 6 weeks
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)
Time frame: From the date of enrolment plus 6 weeks
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
Time frame: From the date of enrolment plus 6 weeks
Patients in whom ctDNA result negated need for tissue biopsy
The number (%) of patients in whom ctDNA result negated need for tissue biopsy
Time frame: From the date of enrolment plus 6 weeks
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
Time frame: From the date of enrolment plus 6 weeks
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
Time frame: From the date of enrolment plus 6 weeks
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
Time frame: From the date of enrolment plus 18 weeks
Plan to share: No — Currently there are no plans to share individual participant data. This will be considered by the trial team, and updated in future if required.
No publications or documents are linked to this record.
Started May 2025 (actual). Primary completion is estimated for Dec 2026, 19 months after the start.
Of 343 non-industry interventional studies with no phase under Carcinoma, Non-Small-Cell Lung, half reached primary completion within 52 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 98. This study's planned 19 months is below that.
Counting every sponsor, half of 359 studies reached it within 51 months; a quarter within 26 and three quarters within 97.
How these figures are worked out, and which studies are left out of them.
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