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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients who have had progressive disease on therapy within the 6 weeks prior to consent | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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):
| From the date of enrolment plus 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From the date of enrolment plus 6 weeks |
| Patients in whom ctDNA result identified a genomically-matched clinical trial (based in the UK) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From the date of enrolment plus 6 weeks |
| Association of allelic frequency in ctDNA with tumour burden in all cohorts |
Inclusion Criteria
All cohorts:
Cohort 1: Locally Advanced/Metastatic NSCLC
Cohort 2: Locally Advanced/Metastatic GIST
Cohort 3: Metastatic Colorectal Cancer
• Metastatic colorectal cancer, left sided, RAS wild type, HER2 any status, AND
Cohort 4: Locally Advanced/Metastatic BTC
Cohort 5: Advanced/Metastatic ovarian cancer
Exclusion Criteria
All cohorts:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rebecca Brooks | Contact | +44 208 642 6011 | rebecca.brooks@rmh.nhs.uk | |
| Simon Connolly | Contact | +44 208 642 6011 | simon.connolly@rmh.nhs.uk |
| Name | Affiliation | Role |
|---|---|---|
| Sanjay Popat, BSc, MBBS, PhD | Royal Marsden NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Marsden NHS Foundation Trust | Recruiting | London | United Kingdom |
Currently there are no plans to share individual participant data. This will be considered by the trial team, and updated in future if required.
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|
The number (%) of 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 | The number (%) of 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 | The number (%) of patients in whom ctDNA result negated need for tissue biopsy | From the date of enrolment plus 6 weeks |
The correlation 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 | 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 | From the date of enrolment plus 18 weeks |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D046152 | Gastrointestinal Stromal Tumors |
| D015179 | Colorectal Neoplasms |
| D001661 | Biliary Tract Neoplasms |
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007414 | Intestinal Neoplasms |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D001660 | Biliary Tract Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
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