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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01888601
Recruitment Status : Recruiting
First Posted : June 28, 2013
Last Update Posted : May 25, 2018
Cancer Research UK
Information provided by (Responsible Party):
University College, London

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).

Condition or disease
Non-small Cell Lung Cancer

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.

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Study Type : Observational
Estimated Enrollment : 842 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: TRAcking Non-small Cell Lung Cancer Evolution Through Therapy (Rx)
Study Start Date : April 2014
Estimated Primary Completion Date : November 2023
Estimated Study Completion Date : November 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

NSCLC eligible for primary surgery
NSCLC eligible for primary surgery

Primary Outcome Measures :
  1. Intratumour heterogeneity [ Time Frame: Year 5 ]
    • Define the relationship between intratumour heterogeneity and clinical outcome following surgery and adjuvant therapy (including relationships between intratumour heterogeneity and clinical disease stage and histological subtypes of NSCLC).

Biospecimen Retention:   Samples With DNA
tissue, blood, plasma and serum

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Stage I-IIIA NSCLC eligible for primary surgery

Inclusion Criteria:

  • Written Informed consent
  • Patients ≥18 years of age, with early stage I-IIIA disease who are eligible for primary surgery
  • 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 in a specialist centre
  • Performance status 0 or 1
  • Suspected tumour at least 15mm in diameter on pre-operative imaging

Exclusion Criteria:

  • Any other current malignancy or malignancy diagnosed or relapsed within the past 5 years (other than non-melanomatous skin cancer, stage 0 melanoma in situ, and in situ cervical cancer)
  • Psychological condition that would preclude informed consent
  • Treatment with neo-adjuvant therapy for current lung malignancy deemed necessary
  • Adjuvant therapy other than platinum-based chemotherapy and/or radiotherapy
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01888601

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Contact: Harriet Bell 02076799265

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United Kingdom
The Princess Alexandra Hospital NHS Trust Recruiting
Harlow, Essex, United Kingdom, CM20 1QX
Principal Investigator: Dionysis Papadatos-Pastos         
University Hospital Southampton NHS Foundation Trust Recruiting
Southampton, Hampshire, United Kingdom, SO16 6YD
Principal Investigator: Christian Ottensmeier         
University College London Hospitals NHS Foundation Trust Recruiting
London, Select Region, United Kingdom, NW1 2PG
Principal Investigator: Charles Swanton         
Ashford and St Peter's Hospitals NHS Foundation Trust Recruiting
Chertsey, Surrey, United Kingdom, KT16 0PZ
Principal Investigator: Muthuveni Ezhil         
Grampian Health Board Recruiting
Aberdeen, United Kingdom, AB15 6RE
Principal Investigator: Gillian Price         
Heart of England NHS Foundation Trust Recruiting
Birmingham, United Kingdom, B9 5SS
Principal Investigator: Babu Naidu         
Cardiff and Vale University Health Board Recruiting
Cardiff, United Kingdom, CF14 4XW
Principal Investigator: Jason Lester         
NHS Greater Glasgow & Clyde Recruiting
Glasgow, United Kingdom
Principal Investigator: Kevin Blyth         
University Hospitals of Leicester NHS Trust Recruiting
Leicester, United Kingdom, LE1 5WW
Principal Investigator: Dean Fennell         
Liverpool Heart and Chest Hospital Recruiting
Liverpool, United Kingdom
Principal Investigator: Michael Shackcloth         
Royal Free Hospital Recruiting
London Borough Of Camden, United Kingdom, NW3 2QG
Principal Investigator: Ekaterini Boleti         
Barts Health NHS Trust Recruiting
London, United Kingdom, E1 1RD
Principal Investigator: John Conibear         
North Middlesex University Hospital NHS Trust Terminated
London, United Kingdom, N18 1QX
The Whittington Hospital NHS Trust, trading as Whittington Health Recruiting
London, United Kingdom, N19 5NF
Principal Investigator: Sara Lock         
Royal Free London NHS Foundation Trust - Barnet Hospital Recruiting
London, United Kingdom, NW3 2QG
Principal Investigator: Girija Anand         
Royal Brompton & Harefield NHS Foundation Trust Recruiting
London, United Kingdom, SW3 6NP
Principal Investigator: Eric Lim         
University Hospital of South Manchester NHS Foundation Trust Recruiting
Manchester, United Kingdom, M23 9LT
Principal Investigator: Yvonne Summers         
Sheffield Teaching Hospitals NHS Foundation Trust Recruiting
Sheffield, United Kingdom, S5 7AU
Principal Investigator: Sarah Danson         
Sponsors and Collaborators
University College, London
Cancer Research UK
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Principal Investigator: Charles Swanton Chief Investigator

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: University College, London Identifier: NCT01888601     History of Changes
Other Study ID Numbers: UCL/12/0279
First Posted: June 28, 2013    Key Record Dates
Last Update Posted: May 25, 2018
Last Verified: May 2018

Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms