Molecular profiling to guide targeted cancer treatments
Tumour Characterisation to Guide Experimental Targeted Therapy - National
This study is testing whether analyzing the DNA from blood and tumors can help doctors choose better treatments for people with advanced solid cancers.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 6000 (estimated) |
| Ages | 16 Years and up |
| Sex | All |
| Sponsor | The Christie NHS Foundation Trust Academic / other |
| Locations | 20 sites (Belfast and 19 other locations) |
| Trial ID | NCT04723316 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are patients aged 16 and over with confirmed advanced solid cancers who are fit for experimental therapies.
Not a fit: Patients with known HIV, Hepatitis B, or Hepatitis C may not benefit from this study due to the handling of high-risk specimens.
Why it matters
Potential benefit: If successful, this approach could lead to more personalized and effective cancer treatments for patients with advanced solid tumors.
How similar studies have performed: Other studies utilizing molecular profiling for targeted cancer therapies have shown promise, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Belfast and 19 other locations
- 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)
- St.James's University Hospital — Leeds, United Kingdom (Recruiting)
- Leicester Cancer Research Centre — Leicester, United Kingdom (Recruiting)
- Royal Free Hospital — London, United Kingdom (Recruiting)
- Kings Health Partners — London, United Kingdom (Recruiting)
- Imperial College London — London, United Kingdom (Not_yet_recruiting)
- UCL Cancer Institute — London, United Kingdom (Recruiting)
- The Christie NHS Foundation Trust — Manchester, United Kingdom (Recruiting)
- The Clatterbridge Cancer Centre NHS Foundation Trust — Metropolitan Borough of Wirral, United Kingdom (Recruiting)
- The Newcastle Upon Tyne NHS Foundation Trust — Newcastle, United Kingdom (Recruiting)
- Oxford University Hospitals NHS Foundation Trust — Oxford, United Kingdom (Recruiting)
- Royal Preston Hospital — Preston, United Kingdom (Recruiting)
- Sheffield University Hospitals NHS Foundation Trust — Sheffield, United Kingdom (Recruiting)
- University Hospitals Southampton NHS Foundation Trust — Southampton, United Kingdom (Recruiting)
- ICR & The Royal Marsden — Sutton, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Matthew Krebs
- Email: the-christie.target.national@nhs.net
- Phone: 01619187672
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.