Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07673861

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Non Small Cell Lung Cancer Adnexal Diseases Biliary Tract Cancer Biliary Tract Diseases Biliary Tract Neoplasms Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Colonic Diseases Colorectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Gastrointestinal Stromal Tumor (GIST) Gastrointestinal Stromal Tumors Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Intestinal Diseases Intestinal Neoplasms Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Ovarian Cancer Ovarian Diseases Ovarian Neoplasms Rectal Diseases Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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

    Time frame: From the date of enrolment plus 6 weeks

    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

Secondary outcomes

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

    Time frame: From the date of enrolment plus 6 weeks

    The number (%) of patients in whom ctDNA result identified a genomically-matched SOC therapy

  2. 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

    The number (%) of patients in whom ctDNA result identified a genomically-matched clinical trial (based in the UK)

  3. 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

    The number (%) of patients in whom ctDNA result offered additional prognostic information not otherwise available through SOC testing

  4. Patients in whom ctDNA result negated need for tissue biopsy

    Time frame: From the date of enrolment plus 6 weeks

    The number (%) of patients in whom ctDNA result negated need for tissue biopsy

Other outcomes

  1. Number of, and name of, resistance mutations pertinent to each cohort

    Time frame: From the date of enrolment plus 6 weeks

    The number (absolute value) of, and name of, resistance mutations that occur in at least 10% of participants in each cohort

  2. Association of allelic frequency in ctDNA with tumour burden in all cohorts

    Time frame: From the date of enrolment plus 6 weeks

    The correlation of allelic frequency in ctDNA with tumour burden in all cohorts

  3. Number 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

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Rebecca Brooks

CONTACT

[email protected]

+44 208 642 6011

Simon Connolly

CONTACT

[email protected]

+44 208 642 6011

Sponsors and collaborators

Lead sponsor

Royal Marsden NHS Foundation Trust

Other

Registry information

Official study title

Clinical Utility of ctDNA in Detecting Resistance Mechanisms and Delivering Precision Medicine: A Tumour Agnostic Study

Acronym: CURTAIN

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 29, 2026
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.