Tumour Characterisation to Guide Experimental Targeted Therapy - National
- Conditions
- Cancer
- Registration Number
- NCT04723316
- Lead Sponsor
- The Christie NHS Foundation Trust
- Brief Summary
The primary aim of TARGET National is to establish a national framework to offer molecular profiling of circulating tumour DNA and/or tumour tissue (optional) to patients with advanced solid cancers referred to any of the Experimental Cancer Medicine Centres (ECMCs) across the UK, in order to help decision making for allocation to molecularly targeted experimental cancer treatments. Patients will be allocated treatment using a national Molecular Tumour Board to find the most suited therapies based on their molecular profiling results.
This study aims to recruit up to 6,000 patients with advanced solid tumours across 5 years and proposes to collect blood samples, archival tumour tissue and fresh tissue (optional)
The data may also be used for future development of predictive cancer biological markers, the design of clinical trials involving new or existing drugs, discovery of new genetic targets and exploring how resistance to specific anticancer agents arises in patients to help improve future cancer treatment management.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 6000
- Aged 16 years or over.
- Written informed consent according to GCP and national regulations.
- Patients with confirmed histological or cytological diagnosis of advanced solid cancer who have been referred to any of the ECMCs in the UK AND considered fit enough to receive an experimental therapeutic agent.
- Availability of archival tumour sample (if tumour profiling is required)
- Willingness to provide blood samples during the course of the study if allocated to a matched experimental therapy.
- Known HIV, Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or Hepatitis C virus (defined as HCV RNA detected), due to the difficulties in handling high-risk specimens. Routine testing for hepatitis is not required. Note: Patients with past/resolved Hepatitis B infection (defined as having a negative HBsAg test and a positive antibody to hepatitis B core antigen [anti-HBc] antibody test) are eligible. Patients with a history of Hepatitis C infection are eligible only if polymerase chain reaction (PCR) analysis is negative for HCV RNA at least 6 months after completing treatment for Hepatitis C infection.
- Known current COVID19 positive (by PCR) or active symptoms for COVID19. Routine testing for COVID19 is not required. Patients with past infection who have fully recovered may be included.
- Patients who are unable to provide fully informed written consent.
- Patients not considered eligible by the investigator for early phase clinical trials.
- Patients currently receiving systemic anti-cancer therapy (due to potential impact on ctDNA analysis), unless patient has clear evidence of progression on hormone-based therapies or tyrosine kinase inhibitors. A minimum of 3 weeks is required post completion of other systemic anti-cancer therapies.
- Presence of any medical, psychological, familial or sociological condition that, in the investigator's opinion, will hamper compliance with the study protocol and follow-up schedule.
- Bleeding diathesis (patients' on anticoagulation are permitted to enter the trial if anticoagulation can be safely managed to enable fresh tumour biopsies and blood sampling).
- Conditions in which research biopsies or blood sampling may increase risk of complications for the patients and/or investigator
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine the number of patients matched to a trial of an experimental therapeutic agent based on molecular findings from ctDNA or tumour 5 years
- Secondary Outcome Measures
Name Time Method Number of patients and cancer types with successful result obtained from ctDNA. 5 years Overall response rates of patients who commence on a trial of an experimental therapeutic agent (matched or unmatched) on the basis of molecular findings in this study). 5 years Progression-free survival of patients who commence on a trial of an experimental therapeutic agent (matched or unmatched on the basis of molecular findings in this study). 5 years Turnaround times from date of patient consent to date of genomic tumour profiling report generation. 5 years Number and range of molecular alterations found in blood (and/or tumour) of cancer patients referred to Experimental Cancer Medicine Centres. 5 years Overall survival of patients who commence on a trial of an experimental therapeutic agent (matched or unmatched on the basis of molecular findings in this study). 5 years
Trial Locations
- Locations (20)
Queen's University Belfast
🇬🇧Belfast, United Kingdom
University Hospitals Birmingham NHS Foundation Trust
🇬🇧Birmingham, United Kingdom
Cambridge University Hospitals NHS Foundation Trust
🇬🇧Cambridge, United Kingdom
Cardiff University and Velindre Cancer Centre
🇬🇧Cardiff, United Kingdom
Western General Hospital Edinburgh Cancer Centre
🇬🇧Edinburgh, United Kingdom
Beatson West of Scotland Cancer Centre
🇬🇧Glasgow, United Kingdom
St.James's University Hospital
🇬🇧Leeds, United Kingdom
Leicester Cancer Research Centre
🇬🇧Leicester, United Kingdom
ICR & The Royal Marsden
🇬🇧London Borough of Sutton, United Kingdom
The Newcastle Upon Tyne NHS Foundation Trust
🇬🇧Newcastle, United Kingdom
Oxford University Hospitals NHS Foundation Trust
🇬🇧Oxford, United Kingdom
Royal Preston Hospital
🇬🇧Preston, United Kingdom
Sheffield University Hospitals NHS Foundation Trust
🇬🇧Sheffield, United Kingdom
University Hospitals Southampton NHS Foundation Trust
🇬🇧Southampton, United Kingdom
The Clatterbridge Cancer Centre NHS Foundation Trust
🇬🇧Wirral, United Kingdom
Royal Free Hospital
🇬🇧London, United Kingdom
Kings Health Partners
🇬🇧London, United Kingdom
Imperial College London
🇬🇧London, United Kingdom
UCL Cancer Institute
🇬🇧London, United Kingdom
The Christie NHS Foundation Trust
🇬🇧Manchester, United Kingdom