Tumour Characterisation to Guide Experimental Targeted Therapy - National

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 Overview

• Status: Recruiting
• Conditions: Cancer

• Study Type: Observational
• Enrollment (Estimated): 6000

Contacts and Locations

• Study Contact: Name: Matthew Krebs; Phone Number: 01619187672; Email: the-christie.target.national@nhs.net

Study Locations

• United Kingdom
  • Belfast, United Kingdom, BT7 1NN
    • Recruiting
    • Queen's University Belfast
    • Contact: Vicky Coyle
  • Birmingham, United Kingdom, B15 2TH
    • Recruiting
    • University Hospitals Birmingham NHS Foundation Trust
    • Contact: Mark Openshaw
  • Cambridge, United Kingdom, CB20QQ
    • Recruiting
    • Cambridge University Hospitals NHS Foundation Trust
    • Contact: Bristi Basu
  • Cardiff, United Kingdom, CF142TL
    • Recruiting
    • Cardiff University and Velindre Cancer Centre
    • Contact: Robert Jones
  • Edinburgh, United Kingdom, EH2 2SP
    • Recruiting
    • Western General Hospital Edinburgh Cancer Centre
    • Contact: Stefan Symeonides
  • Glasgow, United Kingdom, G12 0YN
    • Recruiting
    • Beatson West of Scotland Cancer Centre
    • Contact: Patricia Roxburgh
  • Leeds, United Kingdom, LS97TF
    • Recruiting
    • St.James's University Hospital
    • Contact: Fiona Collinson
  • Leicester, United Kingdom, LE27LX
    • Recruiting
    • Leicester Cancer Research Centre
    • Contact: Olubukola Ayodele
  • London, United Kingdom, NW3 2QG
    • Recruiting
    • Royal Free Hospital
    • Contact: Robert Goldstein
  • London, United Kingdom, W120NN
    • Not yet recruiting
    • Imperial College London
    • Contact: Nicola Valeri
  • London, United Kingdom, SE1 9RT
    • Recruiting
    • Kings Health Partners
    • Contact: James Spicer
  • London, United Kingdom, WC1E6BT
    • Recruiting
    • UCL Cancer Institute
    • Contact: Martin Forster
  • London Borough of Sutton, United Kingdom, SM2 5NG
    • Recruiting
    • ICR & The Royal Marsden
    • Contact: Anna Minchom
  • Manchester, United Kingdom, M20 4BX
    • Recruiting
    • The Christie NHS Foundation Trust
    • Contact: Matthew Krebs; Email: matthew.krebs@nhs.net
  • Newcastle, United Kingdom, NE7 7DN
    • Recruiting
    • The Newcastle Upon Tyne NHS Foundation Trust
    • Contact: Alastair Greystoke
  • Oxford, United Kingdom, OX3 7DQ
    • Recruiting
    • Oxford University Hospitals NHS Foundation Trust
    • Contact: Eileen Parkes
  • Preston, United Kingdom, PR2 9HT
    • Recruiting
    • Royal Preston Hospital
    • Contact: Ruth Board
  • Sheffield, United Kingdom, S5 7AU
    • Recruiting
    • Sheffield University Hospitals NHS Foundation Trust
    • Contact: Robin Young
  • Southampton, United Kingdom, SO16 6YD
    • Recruiting
    • University Hospitals Southampton NHS Foundation Trust
    • Contact: Ellen Copson
  • Wirral, United Kingdom, CH63 4JY
    • Recruiting
    • The Clatterbridge Cancer Centre NHS Foundation Trust
    • Contact: Daniel Palmer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Potential study participants will be identified from patients with advanced solid cancer who have been referred for consideration of early phase clinical trials in ECMCs across the UK. Patients who meet the eligibility criteria and provide fully informed written consent will be enrolled into the study

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
Number of patients and cancer types with successful result obtained from ctDNA.	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 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
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

Collaborators and Investigators

• Sponsor: The Christie NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2021
• Primary Completion (Estimated): January 30, 2026
• Study Completion (Estimated): January 30, 2028

Study Registration Dates

• First Submitted: January 7, 2021
• First Submitted That Met QC Criteria: January 22, 2021
• First Posted (Actual): January 25, 2021

Study Record Updates

• Last Update Posted (Actual): February 7, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: CFTSp191

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No