Status:
ACTIVE_NOT_RECRUITING
TRAcking Non-small Cell Lung Cancer Evolution Through Therapy (Rx)
Lead Sponsor:
University College, London
Collaborating Sponsors:
Cancer Research UK
Conditions:
Non-small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Brief Summary
To study the NSCLC evolutionary genomic landscape between primary and metastatic sites and the dynamics of intratumour heterogeneity over time combined with detailed clinical, histopathological and ca...
Detailed Description
The importance of intratumour genetic and functional heterogeneity is increasingly recognised as a driver of cancer progression and survival outcome. Understanding how tumour clonal heterogeneity impa...
Eligibility Criteria
Inclusion
- Written Informed consent
- Patients ≥18 years of age, with early stage IIA-IIIB disease (according to TNM 8th edition) who are eligible for primary surgery. Patients with a radiological staging of IB (N0) who could be upstaged to IIA-IIIB following surgery (due to the presence of possible nodal involvement on the pre-operative scan) may also be included, but will be withdrawn if post-surgical staging remains IB.
- Histopathologically confirmed NSCLC, or a strong suspicion of cancer on lung imaging necessitating surgery (e.g. diagnosis determined from frozen section in theatre)
- Primary surgery in keeping with NICE guidelines planned (see section 9.3)
- Agreement to be followed up at a TRACERx site
- Performance status 0 or 1
- Minimum tumour diameter at least 15mm to allow for sampling of at least two tumour regions (if 15mm, a high likelihood of nodal involvement on pre-operative imaging required to meet eligibility according to stage, i.e. T1N1-3)
Exclusion
- Any other\* malignancy diagnosed or relapsed at any time, which is currently being treated (including by hormonal therapy).
- Any other\* current malignancy or malignancy diagnosed or relapsed within the past 3 years\*\*.
- \*Exceptions are: non-melanomatous skin cancer, stage 0 melanoma in situ, and in situ cervical cancer
- \*\*An exception will be made for malignancies diagnosed or relapsed more than 2, but less than 3, years ago only if a pre-operative biopsy of the lung lesion has confirmed a diagnosis of NSCLC.
- Psychological condition that would preclude informed consent
- Treatment with neo-adjuvant therapy for current lung malignancy deemed necessary
- Post-surgery staging is not IIA-IIIB
- Known Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) or syphilis infection.
- Sufficient tissue, i.e. a minimum of two tumour regions, is unlikely to be obtained for the study based on pre-operative imaging
Key Trial Info
Start Date :
April 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2026
Estimated Enrollment :
814 Patients enrolled
Trial Details
Trial ID
NCT01888601
Start Date
April 1 2014
End Date
December 1 2026
Last Update
April 2 2025
Active Locations (18)
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1
The Princess Alexandra Hospital NHS Trust
Harlow, Essex, United Kingdom, CM20 1QX
2
University Hospital Southampton NHS Foundation Trust
Southampton, Hampshire, United Kingdom, SO16 6YD
3
University College London Hospitals NHS Foundation Trust
London, Select Region, United Kingdom, NW1 2PG
4
Ashford and St Peter's Hospitals NHS Foundation Trust
Chertsey, Surrey, United Kingdom, KT16 0PZ