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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01888601
Recruitment Status : Active, not recruiting
First Posted : June 28, 2013
Last Update Posted : February 10, 2023
Sponsor:
Collaborator:
Cancer Research UK
Information provided by (Responsible Party):
University College, London

Study Description
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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.
Study Design
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Study Type : Observational
Actual Enrollment : 814 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 : December 2026
Estimated Study Completion Date : December 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Groups and Cohorts
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Group/Cohort
NSCLC eligible for primary surgery
NSCLC eligible for primary surgery


Outcome Measures
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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

Eligibility Criteria
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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
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
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT01888601


Locations
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Sponsors and Collaborators
University College, London
Cancer Research UK
Investigators
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Principal Investigator: Charles Swanton Chief Investigator
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Jamal-Hanjani M, Wilson GA, McGranahan N, Birkbak NJ, Watkins TBK, Veeriah S, Shafi S, Johnson DH, Mitter R, Rosenthal R, Salm M, Horswell S, Escudero M, Matthews N, Rowan A, Chambers T, Moore DA, Turajlic S, Xu H, Lee SM, Forster MD, Ahmad T, Hiley CT, Abbosh C, Falzon M, Borg E, Marafioti T, Lawrence D, Hayward M, Kolvekar S, Panagiotopoulos N, Janes SM, Thakrar R, Ahmed A, Blackhall F, Summers Y, Shah R, Joseph L, Quinn AM, Crosbie PA, Naidu B, Middleton G, Langman G, Trotter S, Nicolson M, Remmen H, Kerr K, Chetty M, Gomersall L, Fennell DA, Nakas A, Rathinam S, Anand G, Khan S, Russell P, Ezhil V, Ismail B, Irvin-Sellers M, Prakash V, Lester JF, Kornaszewska M, Attanoos R, Adams H, Davies H, Dentro S, Taniere P, O'Sullivan B, Lowe HL, Hartley JA, Iles N, Bell H, Ngai Y, Shaw JA, Herrero J, Szallasi Z, Schwarz RF, Stewart A, Quezada SA, Le Quesne J, Van Loo P, Dive C, Hackshaw A, Swanton C; TRACERx Consortium. Tracking the Evolution of Non-Small-Cell Lung Cancer. N Engl J Med. 2017 Jun 1;376(22):2109-2121. doi: 10.1056/NEJMoa1616288. Epub 2017 Apr 26.

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Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT01888601    
Other Study ID Numbers: UCL/12/0279
First Posted: June 28, 2013    Key Record Dates
Last Update Posted: February 10, 2023
Last Verified: February 2023
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms