Clinical Utility of ctDNA in Detecting Resistance Mechanisms and Delivering Precision Medicine to Cancer Patients

NCT07673861 | Recruiting

• 1 other identifier: CCR6022
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Non Small Cell Lung Cancer; Gastrointestinal Stromal Tumor (GIST); Colorectal Cancer; Biliary Tract Cancer; Ovarian Cancer

Outcome Measures

Primary Outcomes (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

  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

  From the date of enrolment plus 6 weeks

Secondary Outcomes (4)

• Patients in whom ctDNA result identified a genomically-matched SOC therapy

  From the date of enrolment plus 6 weeks

• Patients in whom ctDNA result identified a genomically-matched clinical trial (based in the UK)

  From the date of enrolment plus 6 weeks

• Patients in whom ctDNA result offered additional prognostic information not otherwise available through SOC testing

  From the date of enrolment plus 6 weeks

• Patients in whom ctDNA result negated need for tissue biopsy

  From the date of enrolment plus 6 weeks

Other Outcomes (3)

• Number of, and name of, resistance mutations pertinent to each cohort

  From the date of enrolment plus 6 weeks

• Association of allelic frequency in ctDNA with tumour burden in all cohorts

  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

  From the date of enrolment plus 18 weeks

Study Arms (1)

Patients who have had progressive disease on therapy within the 6 weeks prior to consent

OTHER

Diagnostic Test: Marsden360 ctDNA test and GTAB review

Interventions

Marsden360 ctDNA test and GTAB review DIAGNOSTIC_TEST

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.

Patients who have had progressive disease on therapy within the 6 weeks prior to consent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• All cohorts:
• Medically unstable to commit to sampling required for the study
• ECOG performance status ≥3

Sponsors & Collaborators

• Royal Marsden NHS Foundation Trust: lead

Study Sites (1)

Royal Marsden NHS Foundation Trust

London, United Kingdom

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Gastrointestinal Stromal Tumors; Colorectal Neoplasms; Biliary Tract Neoplasms; Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Biliary Tract Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Sanjay Popat, BSc, MBBS, PhD

  Royal Marsden NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rebecca Brooks

CONTACT

+44 208 642 6011; rebecca.brooks@rmh.nhs.uk

Simon Connolly

CONTACT

+44 208 642 6011; simon.connolly@rmh.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: June 29, 2026
• Study Start: May 23, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 29, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)