Clinical Utility of ctDNA in Detecting Resistance Mechanisms and Delivering Precision Medicine to… (NCT07673861) | Clinical Trial Compass
RecruitingNot Applicable
Clinical Utility of ctDNA in Detecting Resistance Mechanisms and Delivering Precision Medicine to Cancer Patients
United Kingdom100 participantsStarted 2025-05-23
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria
All cohorts:
* 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
Cohort 1: Locally Advanced/Metastatic NSCLC
* Oncogene-addicted NSCLC (i.e. ESCAT Tier 1 oncogenic drivers: EGFR/ALK/ROS1/RET/MET/BRAF/NTRK/HER2/KRAS), AND
* Progressive disease on targeted therapy (any line) within the 6 weeks prior to consent
Cohort 2: Locally Advanced/Metastatic GIST
* Locally advanced/metastatic gastrointestinal stromal tumour (GIST), AND
* Progressive disease on targeted therapy (any line) within the 6 weeks prior to consent
Cohort 3: Metastatic Colorectal Cancer
• Metastatic colorectal cancer, left sided, RAS wild type, HER2 any status, AND
* If HER2 negative or unknown: progressive disease on systemic anti-cancer therapy (SACT) with an anti-EGFR agent (e.g. cetuximab) within the 6 weeks prior to consent
* If HER2 positive: progressive disease on first line systemic anti-cancer therapy (SACT) +/- an anti-EGFR agent within the 6 weeks prior to consent
Cohort 4: Locally Advanced/Metastatic BTC
* Identified targetable mutation (IDH1 mutation/HER2 amplification/FGFR2 fusion or rearrangement/NTRK fusion/BRAF V600E mutation/MMR deficiency \[dMMR\]), AND
* Progressive disease on targeted therapy (any line) demonstrated within the 6 weeks prior to consent
Cohort 5: Advanced/Metastatic ovarian cancer
* Diagnosis of adv…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The number (%) of patients in whom ctDNA result was deemed to be clinically useful at the time of progression on prior line of therapy
Timeframe: From the date of enrolment plus 6 weeks