TARGET NATIONAL

Trial Info

Status: Open

Specialty: Multiple

Date Opened: 14/11/2023

Planned Close Date: 01/01/2026

Sponsor: The Christie NHS Foundation Trust

Principal Investigator: Prof. Ruth Board

Study Title: Tumour Characterisation to Guide Experimental Targeted Therapy - National Expansion

Trial Description

The primary aim of TARGET National is to establish a national framework to offer molecular profiling of circulating tumor 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. The protocol has been written flexibly to allow additional samples to be collected (up to 60ml blood & up to 3 fresh biopsies) for further translational research. The TARGET steering board will oversee proposals for the collection and use of these samples to ensure all work remains within scope of the protocol and ethics approval.

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.

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 Hepatits 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.

Contacts

Research Nurse: Samuel Almond (x2031) Samuel.Almond@lthtr.nhs.uk

Link to EDGE

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