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Analysis of Screen-detected Lung Cancers' Genomic Traits (ASCENT)

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: NCT04204499
Recruitment Status : Recruiting
First Posted : December 19, 2019
Last Update Posted : April 12, 2024
Sponsor:
Information provided by (Responsible Party):
University College, London

Study Description
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Brief Summary:
Prospective, observational cohort study of patients undergoing surgical resection for low dose CT (LDCT) screen-detected lung cancer (detected through the SUMMIT study- ClinicalTrials.gov Identifier: NCT03934866/ lung screening programmes), in which translational research is a fundamental aspect.

Condition or disease
Lung Cancer

Detailed Description:
The ASCENT study seeks to examine the genomic signatures of screen-detected cancers, in order to categorise the biological behaviour of such lesions and correlate this against non-invasive biological and radiological parameters. From these data, the plan is to explore strategies to characterise LDCT-detected cancers through non-invasive means, which the researchers believe may prove key in mitigating potential screening-associated harms.
Study Design
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Study Type : Observational
Estimated Enrollment : 526 participants
Observational Model: Other
Time Perspective: Other
Official Title: Analysis of Screen-detected Lung Cancers' Genomic Traits
Actual Study Start Date : August 10, 2020
Estimated Primary Completion Date : August 30, 2025
Estimated Study Completion Date : March 30, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Genomic exploratory research [ Time Frame: 4 years ]
    Measuring the differences in chromosomal instability between fast- and slow-growing screen detected cancers, quantified by weighted genome integrity index (WGII) derived from whole exome sequencing (WES) data


Biospecimen Retention:   Samples With DNA

Blood collection will take place from consented patients at the time of anaesthetic induction pre-surgery, to include:

  • 4 x 10ml EDTA-Streck tubes for germline DNA/RNA and exploratory biomarker analyses
  • Tumour surplus to diagnostic and pathological requirements will be collected for whole exome sequencing and RNA profiling.
  • Archival Diagnostic FFPE blocks and slides.

Eligibility Criteria
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Ages Eligible for Study:   50 Years to 77 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Screen detected lung cancer patients.
Criteria

Inclusion Criteria:

  1. Diagnosed with confirmed lung cancer or probable lung cancer via LDCT screening.
  2. Planned for, or completed primary surgical resection either for histologically confirmed lung cancer, or strongly suspected lung cancer.
  3. Able to provide written informed consent (or verbal informed consent for participants consenting to retrospective diagnostic samples and data collection only).

Exclusion Criteria:

  1. Treatment with neoadjuvant therapy for current lung malignancy as per local MDT treatment decision.
  2. Known Active Human Immunodeficiency Virus (HIV), Hepatitis B virus, Hepatitis C Virus or Syphilis.
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): NCT04204499


Contacts
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Contact: Laura Hughes 0207 679 9284 ctc.ascent@ucl.ac.uk

Locations
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United Kingdom
St Bart's Hospital Recruiting
London, United Kingdom, EC1A 7BE
Contact: Will Dr Ricketts       william.ricketts@nhs.net   
Contact: Chuen Ryan Dr Khaw       c.khaw@ucl.ac.uk   
Principal Investigator: Will Dr Ricketts         
UCLH Recruiting
London, United Kingdom, NW1 2BU
Contact: Chuen Ryan Dr Khaw       c.khaw@ucl.ac.uk   
Principal Investigator: Sam Prof Janes         
Sponsors and Collaborators
University College, London
Investigators
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Principal Investigator: Sam Janes UCL
More Information
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Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT04204499    
Other Study ID Numbers: 21919
First Posted: December 19, 2019    Key Record Dates
Last Update Posted: April 12, 2024
Last Verified: November 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University College, London:
Genomic signatures
Screen-detected cancer
Non-invasive biological and radiological parameters
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases