Molecular profiling to guide targeted cancer treatments

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to create a national framework for molecular profiling of circulating tumor DNA and tumor tissue in patients with advanced solid cancers across the UK. Patients will be referred to Experimental Cancer Medicine Centres (ECMCs) and their treatment will be guided by a national Molecular Tumor Board based on their molecular profiling results. The study plans to recruit up to 6,000 patients over five years, collecting blood samples and optional tumor tissue to aid in treatment decision-making and future cancer research.

Why it matters

Who can join: the full rules

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

Where it's running

• Queen's University Belfast
  Belfast, United Kingdom Recruiting
• University Hospitals Birmingham NHS Foundation Trust
  Birmingham, United Kingdom Recruiting
• Cambridge University Hospitals NHS Foundation Trust
  Cambridge, United Kingdom Recruiting
• Cardiff University and Velindre Cancer Centre
  Cardiff, United Kingdom Recruiting
• Western General Hospital Edinburgh Cancer Centre
  Edinburgh, United Kingdom Recruiting
• Beatson West of Scotland Cancer Centre
  Glasgow, United Kingdom Recruiting

Study contacts

• Study coordinator: Matthew Krebs
• Email: the-christie.target.national@nhs.net
• Phone: 01619187672

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.