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:
529
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 529 participants with lung cancer screen-detected through the SUMMIT study or the NHS Targeted Lung Health Check programme will be recruited across two London sites over a five year period. Participants' blood and tissue samples will be collected from 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. All patient have surgery as per standard 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
  • planned for (or previously had) primary surgical resection either for histologically confirmed lung cancer, or for strongly suspected lung cancer 
  • 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 Human Immunodeficiency Virus (HIV), Hepatitis B virus, Hepatitis C Virus or Syphilis.

Duration of recruitment: The study will be open to recruitment for 5 years from August 2020. 
Aim

Whole exome sequencing will be performed on ‘slow’ and ‘fast’ 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
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Telephone:
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