Tumour Characterisation to Guide Experimental Targeted Therapy - National

NCT04723316 | Recruiting

• 1 other identifier: CFTSp191
• Study Type: observational
• Target: 6,000
• Locations: 1 country
• Sites: 20

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.

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The Christie NHS Foundation Trust: lead

Study Sites (20)

Queen's University Belfast

Belfast, BT7 1NN, United Kingdom

RECRUITING

University Hospitals Birmingham NHS Foundation Trust

Birmingham, B15 2TH, United Kingdom

RECRUITING

Cambridge University Hospitals NHS Foundation Trust

Cambridge, CB20QQ, United Kingdom

RECRUITING

Cardiff University and Velindre Cancer Centre

Cardiff, CF142TL, United Kingdom

RECRUITING

Western General Hospital Edinburgh Cancer Centre

Edinburgh, EH2 2SP, United Kingdom

RECRUITING

Beatson West of Scotland Cancer Centre

Glasgow, G12 0YN, United Kingdom

RECRUITING

St.James's University Hospital

Leeds, LS97TF, United Kingdom

RECRUITING

Leicester Cancer Research Centre

Leicester, LE27LX, United Kingdom

RECRUITING

Royal Free Hospital

London, NW3 2QG, United Kingdom

RECRUITING

Kings Health Partners

London, SE1 9RT, United Kingdom

RECRUITING

Imperial College London

London, W120NN, United Kingdom

NOT YET RECRUITING

UCL Cancer Institute

London, WC1E6BT, United Kingdom

RECRUITING

The Christie NHS Foundation Trust

Manchester, M20 4BX, United Kingdom

RECRUITING

The Clatterbridge Cancer Centre NHS Foundation Trust

Metropolitan Borough of Wirral, CH63 4JY, United Kingdom

RECRUITING

The Newcastle Upon Tyne NHS Foundation Trust

Newcastle, NE7 7DN, United Kingdom

RECRUITING

Oxford University Hospitals NHS Foundation Trust

Oxford, OX3 7DQ, United Kingdom

RECRUITING

Royal Preston Hospital

Preston, PR2 9HT, United Kingdom

RECRUITING

Sheffield University Hospitals NHS Foundation Trust

Sheffield, S5 7AU, United Kingdom

RECRUITING

University Hospitals Southampton NHS Foundation Trust

Southampton, SO16 6YD, United Kingdom

RECRUITING

ICR & The Royal Marsden

Sutton, SM2 5NG, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples will be collected for ctDNA analysis and germline DNA analysis Tissue samples will be collected for next generation sequencing. Whilst the focus of the study is on next generation sequencing of circulating tumour DNA, the study is not restricted to these analyses. Other tests may be performed, including, but not restricted to: immunohistochemistry, FISH, PCR if such analyses complement the panel of aberrations that may help select a relevant trial of an experimental therapeutic for participating patients. Fresh tumour may also be used for in vitro (i.e. organoids) and/or in vivo experiments (mouse models) (optional) if patients provide their consent. These crucial experiments will improve our understanding of the biology of cancer and will lead to identification of new potential targets for cancer patients, facilitate drug screening and will inform of mechanisms of drug resistance. In summary, analyses may be varied and alter over time as technologies evolve.

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Matthew Krebs

CONTACT

01619187672; the-christie.target.national@nhs.net

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2021
• First Posted: January 25, 2021
• Study Start: June 30, 2021
• Primary Completion: January 30, 2026
• Study Completion (Estimated): January 30, 2028
• Last Updated: February 7, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (20)