NCT04723316 Tumour Characterisation to Guide Experimental Targeted Therapy - National
| NCT ID | NCT04723316 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Christie NHS Foundation Trust |
| Condition | Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 6,000 participants |
| Start Date | 2021-06-30 |
| Primary Completion | 2026-01-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 6,000 participants in total. It began in 2021-06-30 with a primary completion date of 2026-01-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04723316 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, studying Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04723316 currently recruiting?
Yes, NCT04723316 is actively recruiting participants. Contact the research team at the-christie.target.national@nhs.net for enrollment information.
Where is the NCT04723316 trial being conducted?
This trial is being conducted at Belfast, United Kingdom, Birmingham, United Kingdom, Cambridge, United Kingdom, Cardiff, United Kingdom and 11 additional locations.
Who is sponsoring the NCT04723316 clinical trial?
NCT04723316 is sponsored by The Christie NHS Foundation Trust. The trial plans to enroll 6,000 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.