Tumour Characterisation to Guide Experimental Targeted Therapy - National
ConditionCancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age16+
SponsorThe Christie NHS Foundation Trust
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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.
Trial 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
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
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
Time frame
5 yearsSecondary outcomes
1
Number of patients and cancer types with successful result obtained from ctDNA.
Time frame
5 years2
Turnaround times from date of patient consent to date of genomic tumour profiling report generation.
Time frame
5 years3
Number and range of molecular alterations found in blood (and/or tumour) of cancer patients referred to Experimental Cancer Medicine Centres.
Time frame
5 years4
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).
Time frame
5 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov