Official Title
Tumour Characterisation to Guide Experimental Targeted Therapy - National
Brief Title
Tumour Characterisation to Guide Experimental Targeted Therapy - National
Protocol ID
NCT04723316
Lead Sponsor
The Christie NHS Foundation Trust
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.
Study Period
-
Enrollment Count
6,000 participants
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
Filters
Cancer
RECRUITING
CHILD
ADULT
OLDER_ADULT