Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
 
ClinicalTrials.gov Identifier: NCT01888601
Recruitment Status : Recruiting
First Posted : June 28, 2013
Last Update Posted : January 27, 2020
Sponsor:
Collaborator:
Cancer Research UK
Information provided by (Responsible Party):
University College, London

Tracking Information
First Submitted Date June 17, 2013
First Posted Date June 28, 2013
Last Update Posted Date January 27, 2020
Study Start Date April 2014
Estimated Primary Completion Date November 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 25, 2013)
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).
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title TRAcking Non-small Cell Lung Cancer Evolution Through Therapy (Rx)
Official Title TRAcking Non-small Cell Lung Cancer Evolution Through Therapy (Rx)
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
tissue, blood, plasma and serum
Sampling Method Non-Probability Sample
Study Population Stage I-IIIA NSCLC eligible for primary surgery
Condition Non-small Cell Lung Cancer
Intervention Not Provided
Study Groups/Cohorts NSCLC eligible for primary surgery
NSCLC eligible for primary surgery
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 25, 2013)
842
Original Estimated Enrollment Same as current
Estimated Study Completion Date November 2023
Estimated Primary Completion Date November 2023   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Oliver Pressey 02076799010 ctc.tracerx@ucl.ac.uk
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT01888601
Other Study ID Numbers UCL/12/0279
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University College, London
Study Sponsor University College, London
Collaborators Cancer Research UK
Investigators
Principal Investigator: Charles Swanton Chief Investigator
PRS Account University College, London
Verification Date October 2019