Status:
RECRUITING
Tumour Characterisation to Guide Experimental Targeted Therapy - National
Lead Sponsor:
The Christie NHS Foundation Trust
Conditions:
Cancer
Eligibility:
All Genders
16+ years
Brief 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 r...
Eligibility Criteria
Inclusion
- 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)
- Willingness to provide blood samples during the course of the study if allocated to a matched experimental therapy.
Exclusion
- 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.
- 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.
- 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.
- 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).
- Conditions in which research biopsies or blood sampling may increase risk of complications for the patients and/or investigator
Key Trial Info
Start Date :
June 30 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 30 2028
Estimated Enrollment :
6000 Patients enrolled
Trial Details
Trial ID
NCT04723316
Start Date
June 30 2021
End Date
January 30 2028
Last Update
February 7 2024
Active Locations (20)
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1
Queen's University Belfast
Belfast, United Kingdom, BT7 1NN
2
University Hospitals Birmingham NHS Foundation Trust
Birmingham, United Kingdom, B15 2TH
3
Cambridge University Hospitals NHS Foundation Trust
Cambridge, United Kingdom, CB20QQ
4
Cardiff University and Velindre Cancer Centre
Cardiff, United Kingdom, CF142TL