Tumour Characterisation to Guide Experimental Targeted Therapy - National

Launched by THE CHRISTIE NHS FOUNDATION TRUST · Jan 22, 2021

Keywords

ClinConnect Summary

The TARGET National trial is studying how to better treat patients with advanced solid cancers by looking at their unique genetic information. The goal is to collect samples of blood and tumor tissue from up to 6,000 patients across the UK. This information will help doctors understand which experimental treatments might work best for each patient. A special team, called the Molecular Tumour Board, will review the results and make recommendations on targeted therapies based on the individual’s molecular profile.

To participate in this trial, you need to be at least 16 years old and have a confirmed diagnosis of advanced solid cancer. You'll need to provide written consent and may need to give blood samples during the study. If you decide to join, you can expect to have your genetic information analyzed, which could help improve not only your treatment options but also future cancer therapies for others. It's important to note that certain health conditions may disqualify you from participating, so be sure to discuss your situation with your healthcare provider.

Gender

ALL

Eligibility criteria

• 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