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Trial Details
Trial status:
Active (recruiting)
Recruitment start date:
10/08/2020
Funder:
Cancer Research UK
Sponsor:
UCL
Chief Investigator:
Professor Sam Janes
Recruitment target:
427
EudraCT number:
N/A
Contact details:
ctc.ascent@ucl.ac.uk
Lay summary:
ASCENT
Analysis of screen-detected lung cancers’ genomic traits
Description
Design: ASCENT is an observational study. An estimated 427 participants with lung cancer screen-detected through the SUMMIT study will be recruited across two London sites over a three year period. Blood and tissue samples will be collected from participants at the time of surgery. A series of sequencing and biomarker analyses on the samples will be correlated against diagnostic and LDCT scans. The main objectives are as follows:

Primary objective:

To evaluate the genomic characteristics of screen-detected lung cancers, determining features predictive of radiological appearance and growth rates.

 Secondary objectives:

  • to fully characterise the genomic character of screen-detected cancers as compared to clinically-diagnosed disease
  • correlate genomic signatures against preceding radiological growth rates on LDCT and pre-operative FDG-CT PET imaging characteristics
  • develop non-invasive strategies for distinguishing screen-detected lesions at highest risk of aggressive growth versus those that are non-aggressive 
  • assess the DNA/RNA/protein and cellular changes and their association to disease occurrence.

Treatment: There is no treatment within the ASCENT Study. At the time of study entry, all participants will undergo surgery for lung cancer removal in accordance with NICE guidelines.
Key inclusion/exclusion criteria: Participants will not be required to have a physical examination during screening. 

Medical data will be checked to ensure the participant is:
  • diagnosed with confirmed lung cancer or probable lung cancer via LDCT-screening as part of the SUMMIT study
  • planned for primary surgical resection either for histologically confirmed lung cancer, or for strongly suspected lung cancer to be diagnosed via frozen section
  • able to provide written informed consent.
Participants are ineligible if any of the following apply:
  • local MDT decision for treatment with neoadjuvant therapy for current lung malignancy
  • the patient has active HumanImmunodeficiency Virus (HIV), Hepatitis B virus, Hepatitis C Virus or Syphilis.

Duration of recruitment: The study will be open to recruitment for 3 years from August 2020. 
Aim

Whole exome sequencing will be performed on ‘fast’  and ‘slow’ growing tumour samples to characterise indolent versus aggressive features. Guided by these initial analyses, exploratory biomarker and radiomic analyses will be carried out with the aim of identifying future prognostic features through non-invasive means which may prove key in mitigating potential screening-associated harms, such as over diagnosis, delayed diagnosis and benign resection.

Trial protocols
Trial protocols must not be applied to patients treated outside trials. UCL CTC can only ensure that approved trial investigators are provided with amendments to protocols.
No protocols have been currently made available for download
Trial documents
No documents have been currently made available for download
Contact Us
Cancer Research UK & UCL Cancer Trials Centre
University College London
90 Tottenham Court Road
London
W1T 4TJ

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Email:
ctc.enquiries@ucl.ac.uk
Telephone:
+44 (0)20 7679 9898 (General CTC Enquiries)
Fax:
020 7679 9899
University College London, Gower Street, London, WC1E 6BT +44 (0)20 7679 2000

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