TRAcking Non-small Cell Lung Cancer Evolution Through Therapy (Rx)

NCT ID: NCT01888601

Last Updated: 2025-04-02

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 814 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2026-12-31

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 cancer phenotypic annotation for each patient, in order to significantly improve the outcomes of NSCLC patients (e.g. reduce their chance of recurrence and improve survival).

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 impacts upon therapeutic outcome, however, is still an area of unmet clinical and scientific need. TRACERx (TRAcking non-small cell lung Cancer Evolution through therapy [Rx]), a prospective study of patients with primary non-small cell lung cancer (NSCLC), aims to define the evolutionary trajectories of lung cancer in both space and time through multiregion and longitudinal tumour sampling and genetic analysis. By following cancers from diagnosis to relapse, tracking the evolutionary trajectories of tumours in relation to therapeutic interventions, and determining the impact of clonal heterogeneity on clinical outcomes, TRACERx may help to identify novel therapeutic targets for NSCLC and may also serve as a model applicable to other cancer types.

Conditions

Non-small Cell Lung Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

NSCLC eligible for primary surgery

NSCLC eligible for primary surgery

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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surgery (due to the presence of possible nodal involvement on the pre-operative scan) may also be included, but will be withdrawn if post-surgical staging remains IB.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 Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cancer Research UK

OTHER

Sponsor Role: collaborator

University College, London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Charles Swanton

Role: PRINCIPAL_INVESTIGATOR

Chief Investigator

Locations

The Princess Alexandra Hospital NHS Trust

Harlow, Essex, United Kingdom

University Hospital Southampton NHS Foundation Trust

Southampton, Hampshire, United Kingdom

University College London Hospitals NHS Foundation Trust

London, Select Region, United Kingdom

Ashford and St Peter's Hospitals NHS Foundation Trust

Chertsey, Surrey, United Kingdom

Grampian Health Board

Aberdeen, , United Kingdom

Heart of England NHS Foundation Trust

Birmingham, , United Kingdom

Cardiff and Vale University Health Board

Cardiff, , United Kingdom

NHS Greater Glasgow & Clyde

Glasgow, , United Kingdom

University Hospitals of Leicester NHS Trust

Leicester, , United Kingdom

Liverpool Heart and Chest Hospital

Liverpool, , United Kingdom

Barts Health NHS Trust

London, , United Kingdom

North Middlesex University Hospital NHS Trust

London, , United Kingdom

The Whittington Hospital NHS Trust, trading as Whittington Health

London, , United Kingdom

Royal Free Hospital

London, , United Kingdom

Royal Free London NHS Foundation Trust - Barnet Hospital

London, , United Kingdom

Royal Brompton & Harefield NHS Foundation Trust

London, , United Kingdom

University Hospital of South Manchester NHS Foundation Trust

Manchester, , United Kingdom

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, , United Kingdom

Countries

United Kingdom

References

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Other Identifiers

UCL/12/0279

Identifier Type: -

Identifier Source: org_study_id