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OpenObservation Study

Tumour Characterisation to Guide Experimental Targeted Therapy - National

For Condition: Cancer

ID: NCT04723316

Horizon Patient Guidance Summary

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How it’s taken
Diet & Lifestyle / Therapy Care
Expected Availability Horizon
General pipeline timeline
StageGeneral evaluation study exploring treatment methods.
EligibleThis study is looking exclusively for patients diagnosed with the condition.
About This Clinical Trial

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.

Study Timeline & Quick Facts
Trial Status
Open — Looking for Participants
Total Target Enrollment
6K patients (Estimated)
Study Start Date
2021-06-30
Est. Primary Completion
2026-01-30
Can I Join This Study?
Suitable For
Everyone welcome
Ages Welcome
16 Years and older
Full Criteria Checklist
Who Can Join
  • 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.
Who Cannot Join
  • 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
What is this Study Measuring?

Primary Outcome Measures

  • To determine the number of patients matched to a trial of an experimental therapeutic agent based on molecular findings from ctDNA or tumour — Time Frame: 5 years
View Secondary Outcome Measures (6)
  • Number of patients and cancer types with successful result obtained from ctDNA. — Time Frame: 5 years
  • Turnaround times from date of patient consent to date of genomic tumour profiling report generation. — Time Frame: 5 years
  • Number and range of molecular alterations found in blood (and/or tumour) of cancer patients referred to Experimental Cancer Medicine Centres. — Time Frame: 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). — Time Frame: 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). — Time Frame: 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). — Time Frame: 5 years
Where to Participate

This trial is recruiting at 20 study facilities worldwide. Click below to see if there is a clinic or hospital in your area:

Show All 20 Facilities & Contact Sites
Queen's University Belfast
Belfast, United Kingdom
Status: Open
University Hospitals Birmingham NHS Foundation Trust
Birmingham, United Kingdom
Status: Open
Cambridge University Hospitals NHS Foundation Trust
Cambridge, United Kingdom
Status: Open
Cardiff University and Velindre Cancer Centre
Cardiff, United Kingdom
Status: Open
Western General Hospital Edinburgh Cancer Centre
Edinburgh, United Kingdom
Status: Open
Beatson West of Scotland Cancer Centre
Glasgow, United Kingdom
Status: Open
St.James's University Hospital
Leeds, United Kingdom
Status: Open
Leicester Cancer Research Centre
Leicester, United Kingdom
Status: Open
Royal Free Hospital
London, United Kingdom
Status: Open
Kings Health Partners
London, United Kingdom
Status: Open
Imperial College London
London, United Kingdom
Status: Opening Soon
UCL Cancer Institute
London, United Kingdom
Status: Open
The Christie NHS Foundation Trust
Manchester, United Kingdom
Status: Open
The Clatterbridge Cancer Centre NHS Foundation Trust
Metropolitan Borough of Wirral, United Kingdom
Status: Open
The Newcastle Upon Tyne NHS Foundation Trust
Newcastle, United Kingdom
Status: Open
Oxford University Hospitals NHS Foundation Trust
Oxford, United Kingdom
Status: Open
Royal Preston Hospital
Preston, United Kingdom
Status: Open
Sheffield University Hospitals NHS Foundation Trust
Sheffield, United Kingdom
Status: Open
University Hospitals Southampton NHS Foundation Trust
Southampton, United Kingdom
Status: Open
ICR & The Royal Marsden
Sutton, United Kingdom
Status: Open
Sponsoring Teams & Contacts
Lead Sponsoring Institution
The Christie NHS Foundation Trust
Primary Research Contact
Matthew Krebs
Tel: 01619187672
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Tumour Characterisation to Guide Experimental Targeted Therapy - National