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Tumour Characterisation to Guide Experimental Targeted Therapy - National

Sponsor: The Christie NHS Foundation Trust

NCT ID: NCT04723316

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Health checks and monitoring — no treatment given
Type of study
Observational (no treatment given)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Not specified by the sponsor
How long the study runs
Study runs about 79 months (dates as stated)
About the drug or intervention
Not specified by the sponsor
Patient visit burden
Not specified by the sponsor
Type of study
Observing health over time
Ages
16 Years and over
Who
All
Number of participants
6,000
Started
2021-06-30
Last checked
2024-02

Plain English Summary

What is this study?

  • • Testing a new treatment for cancer
  • • Clinical study - 6,000 participants
  • • 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

Who can take part?

  • • Ages 16 Years and over
  • • Diagnosed with cancer

Where?

  • • Belfast - Queen's University Belfast
  • • Birmingham - University Hospitals Birmingham NHS Foundation Trust
  • • Cambridge - Cambridge University Hospitals NHS Foundation Trust
  • • Cardiff - Cardiff University and Velindre Cancer Centre
  • • +16 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This 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.

Cancer

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 16 Years and over
  • Who can join: All genders

Biomarkers mentioned

having a negativeand a positiveanalysis is negativeCOVID19 positive

What the study is looking for

  • ✓Aged 16 years or over.
  • ✓Written agreement to take part according to GCP and national regulations.
  • ✓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 take part

  • ✗Known current COVID19 positive (by PCR) or active symptoms for COVID19. Routine testing for COVID19 is not required....
  • ✗Patients who are unable to provide fully informed written consent.
  • ✗Patients not considered eligible by the investigator for early phase clinical trials.
  • ✗Presence of any medical, psychological, familial or sociological condition that, in the investigator's opinion, will...
  • ✗Bleeding diathesis (patients' on anticoagulation are permitted to enter the trial if anticoagulation can be safely...
See the full criteria
Inclusion Criteria: 1. Aged 16 years or over. 2. Written informed consent according to GCP and national regulations. 3. 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. 4. Availability of archival tumour sample (if tumour profiling is required) 5. Willingness to provide blood samples during the course of the study if allocated to a matched experimental therapy. Exclusion Criteria: 1. 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. 2. 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. 3. Patients who are unable to provide fully informed written consent. 4. Patients not considered eligible by the investigator for early phase clinical trials. 5. 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. 6. 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. 7. 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). 8. Conditions in which research biopsies or blood sampling may increase risk of complications for the patients and/or investigator

Where Is This Study? (20 UK sites)

Queen's University Belfast

Belfast BT7 1NN, United Kingdom

Recruiting

University Hospitals Birmingham NHS Foundation Trust

Birmingham B15 2TH, United Kingdom

Recruiting
Hospital R&D contact (matched)

Sarah Pountain Head of Research Governance

R&D@uhb.nhs.uk0121 371 4185

Cambridge University Hospitals NHS Foundation Trust

Cambridge CB20QQ, United Kingdom

Recruiting
Hospital R&D contact (matched)

Stephen Kelleher

cuh.research@nhs.net01223 348490

Cardiff University and Velindre Cancer Centre

Cardiff CF142TL, United Kingdom

Recruiting
Hospital R&D contact (matched)

Sarah Townsend

Velindre.R&Doffice@wales.nhs.uk02920 196165

Western General Hospital Edinburgh Cancer Centre

Edinburgh EH2 2SP, United Kingdom

Recruiting

Beatson West of Scotland Cancer Centre

Glasgow G12 0YN, United Kingdom

Recruiting
Hospital R&D contact (matched)

Jennifer McLean

jennifer.mclean@health.scot.nhs.uk0131 537 4718

St.James's University Hospital

Leeds LS97TF, United Kingdom

Recruiting
Hospital R&D contact (matched)

R&I Team

leedsth-tr.researchfacilitation@nhs.net0113 2060469

Leicester Cancer Research Centre

Leicester LE27LX, United Kingdom

Recruiting
Hospital R&D contact (matched)

Carolyn Maloney

uhl-tr.researchandinnovationadminmailbox@nhs.net0116 258 8351

Royal Free Hospital

London NW3 2QG, United Kingdom

Recruiting
Hospital R&D contact (matched)

Natasha Ajraam

rf-tr.randd@nhs.net020 375 82150

Kings Health Partners

London SE1 9RT, United Kingdom

Recruiting
Hospital R&D contact (matched)

Craig Macpherson (He/Him)

craig.macpherson@kcl.ac.uk07939 578916

Imperial College London

London W120NN, United Kingdom

NOT_YET_RECRUITING
Hospital R&D contact (matched)

Donna Copeland

donna.copeland@nhs.net---

UCL Cancer Institute

London WC1E6BT, United Kingdom

Recruiting

The Christie NHS Foundation Trust

Manchester M20 4BX, United Kingdom

Recruiting
Site contact (verified)

The Clatterbridge Cancer Centre NHS Foundation Trust

Metropolitan Borough of Wirral CH63 4JY, United Kingdom

Recruiting
Hospital R&D contact (matched)

Dr Maria Maguire

maria.maguire2@nhs.net0151 556 5321

The Newcastle Upon Tyne NHS Foundation Trust

Newcastle NE7 7DN, United Kingdom

Recruiting
Hospital R&D contact (matched)

Research and Development

nuth.genericqueries@nhs.net0191 282 4926

Oxford University Hospitals NHS Foundation Trust

Oxford OX3 7DQ, United Kingdom

Recruiting
Hospital R&D contact (matched)

Shahista Hussain

ouhtma@ouh.nhs.uk---

Royal Preston Hospital

Preston PR2 9HT, United Kingdom

Recruiting
Hospital R&D contact (matched)

Paul Brown

Research.Access@lthtr.nhs.uk01772 522031

Sheffield University Hospitals NHS Foundation Trust

Sheffield S5 7AU, United Kingdom

Recruiting
Hospital R&D contact (matched)

Alessia Dunn

STH.ResearchAdministration@nhs.net0114 2712550

University Hospitals Southampton NHS Foundation Trust

Southampton SO16 6YD, United Kingdom

Recruiting
Hospital R&D contact (matched)

Dr Mikayala King

researchmanagement@uhs.nhs.uk023 81208215

ICR & The Royal Marsden

Sutton SM2 5NG, United Kingdom

Recruiting
Hospital R&D contact (matched)

Mark Brandon-Grove

research.development@rmh.nhs.uk020 3186 5416

How to Get in Touch

Matthew Krebs

Sponsor contact

CONTACT

01619187672 the-christie.target.national@nhs.net
Data sourced from ClinicalTrials.gov · Last verified: 2024-02