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Trial Details
Trial status:
Active (recruiting)
Recruitment start date:
01/04/2014
Funder:
Cancer Research UK, Academy for Medical Sciences, Rosetrees Trust & UCL Biomedical Research Centre
Sponsor:
UCL
Chief Investigator:
Prof. Charles Swanton
Recruitment target:
minimum of 750 eligible patients with an upper limit of 842 eligible patients
EudraCT number:
N/A
Contact details:
ctc.tracerx@ucl.ac.uk
Lay summary:
TRACERx
TRAcking non small cell lung Cancer Evolution through therapy (Rx)
Description
Design: TRACERx is a prospective observational cohort study of patients with non-small cell lung cancer (NSCLC), in which translational research is the fundamental aspect of the study.
Treatment: All recruited patients will be suitable for primary surgery, in accordance with NICE guidelines. Further treatments (e.g. chemotherapy) would be given according to standard of care. No treatments are specified as part of this observational study.
Key inclusion/exclusion criteria: Patients must be over 18, have early stage IIA-IIIB suspected or confirmed NSCLC and be eligible for primary surgery in accordance with NICE guidelines. The suspected lesion must be at least 15mm in diameter on pre-operative imaging, and it must be likely that at least two regions can be obtained from the lesion once excised. Patients cannot have any other current  malignancy or malignancy diagnosed or relapsed at any time, which is currently being treated (including hormonal therapy). Patients cannot have any other current malignancy or malignancy diagnosed or relapsed within the past 3 years (other than non-melanomatous skin cancer, stage 0 melanoma in situ, and in situ cervical cancer). Patients cannot have neo-adjuvant therapy. 

Following registration and surgery, patients will become ineligible (and must be withdrawn) if: there is insufficient tissue collected; the patient is unable to comply with protocol requirements; NSCLC is not confirmed; there is a change in staging to IIIC or IV following surgery; the operative criteria are not met (e.g. incomplete resection with macroscopic residual tumours)
Duration of recruitment: Recruitment is expected to take 7.5 years.
Aim
Through DNA and RNA sequencing of longitudinal multi-region tissue samples, the study aims to define the relationship between intratumour heterogeneity and clinical outcome (disease-free survival and overall survival) following surgery and adjuvant therapy, as well as relationships between intratumour heterogeneity and clinical disease stage and histological subtypes of NSCLC. 
The study also aims to establish the impact of adjuvant platinum-containing regimens upon intratumour heterogeneity in relapsed disease compared to primary resected tumour.

Trial protocols
Trial protocols must not be applied to patients treated outside trials. UCL CTC can only ensure that approved trial investigators are provided with amendments to protocols.
No protocols have been currently made available for download
Trial documents
No documents have been currently made available for download
Contact Us
Cancer Research UK & UCL Cancer Trials Centre
University College London
90 Tottenham Court Road
London
W1T 4TJ

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Email:
ctc.enquiries@ucl.ac.uk
Telephone:
+44 (0)20 7679 9898 (General CTC Enquiries)
Fax:
020 7679 9899
University College London, Gower Street, London, WC1E 6BT +44 (0)20 7679 2000

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