ctDNA-guided precision care for lung, GIST, colorectal, biliary, and ovarian cancers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study uses the Marsden360 ctDNA test to detect resistance mechanisms and inform treatment choices in adults with metastatic or unresectable cancers. Patients with five cancer types are enrolled across five cohorts and receive ctDNA analysis alongside GTAB review to tailor systemic therapy. The trial aims to demonstrate the clinical utility of ctDNA testing within the UK's NHS to enhance precision oncology delivery. Participants must have incurable disease, be treated at Royal Marsden, and provide informed consent. The study is centered at a single UK institution with no listed external collaborators.

Why it matters

Who can join: the full rules

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 advanced/metastatic high-grade ovarian cancer, AND
* Known BRCA status, AND
* Progressive disease on a PARP-inhibitor (with or without bevacizumab) following platinum-based therapy in the 1st line maintenance setting, within the 6 weeks prior to consent

Exclusion Criteria

All cohorts:

* Medically unstable to commit to sampling required for the study
* ECOG performance status ≥3

Where it's running

• Royal Marsden NHS Foundation Trust
  London, United Kingdom Recruiting

Study contacts

• Principal investigator: Sanjay Popat, BSc, MBBS, PhD — Royal Marsden NHS Foundation Trust
• Study coordinator: Rebecca Brooks
• Email: rebecca.brooks@rmh.nhs.uk
• Phone: +44 208 642 6011

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.