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Following registration and surgery, patients will become ineligible (and must be withdrawn) if: there is insufficient tissue collected; the patient is unable to comply with protocol requirements; NSCLC is not confirmed; there is a change in staging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.