Tumour Characterisation to Guide Experimental Targeted Therapy - National

Cancer Clinical Trial

Official title:

Tumour Characterisation to Guide Experimental Targeted Therapy - National

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04723316
• Other study ID #: CFTSp191
• Status: Recruiting
• Start date: June 30, 2021
• Est. completion date: January 30, 2028

Study information

• Verified date: February 2024
• Source: The Christie NHS Foundation Trust
• Contact: Matthew Krebs
• Phone: 01619187672
• Email: the-christie.target.national[@]nhs.net
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6000
• Est. completion date: January 30, 2028
• Est. primary completion date: January 30, 2026
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Locations

Country	Name	City	State
United Kingdom	Queen's University Belfast	Belfast
United Kingdom	University Hospitals Birmingham NHS Foundation Trust	Birmingham
United Kingdom	Cambridge University Hospitals NHS Foundation Trust	Cambridge
United Kingdom	Cardiff University and Velindre Cancer Centre	Cardiff
United Kingdom	Western General Hospital Edinburgh Cancer Centre	Edinburgh
United Kingdom	Beatson West of Scotland Cancer Centre	Glasgow
United Kingdom	St.James's University Hospital	Leeds
United Kingdom	Leicester Cancer Research Centre	Leicester
United Kingdom	Imperial College London	London
United Kingdom	Kings Health Partners	London
United Kingdom	Royal Free Hospital	London
United Kingdom	UCL Cancer Institute	London
United Kingdom	ICR & The Royal Marsden	London Borough of Sutton
United Kingdom	The Christie NHS Foundation Trust	Manchester
United Kingdom	The Newcastle Upon Tyne NHS Foundation Trust	Newcastle
United Kingdom	Oxford University Hospitals NHS Foundation Trust	Oxford
United Kingdom	Royal Preston Hospital	Preston
United Kingdom	Sheffield University Hospitals NHS Foundation Trust	Sheffield
United Kingdom	University Hospitals Southampton NHS Foundation Trust	Southampton
United Kingdom	The Clatterbridge Cancer Centre NHS Foundation Trust	Wirral

Sponsors (1)

Lead Sponsor	Collaborator
The Christie NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of patients and cancer types with successful result obtained from ctDNA.		5 years
Secondary	Turnaround times from date of patient consent to date of genomic tumour profiling report generation.		5 years
Secondary	Number and range of molecular alterations found in blood (and/or tumour) of cancer patients referred to Experimental Cancer Medicine Centres.		5 years
Secondary	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
Secondary	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
Secondary	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