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

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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

Tracking Information
First Submitted Date December 11, 2019
First Posted Date December 19, 2019
Last Update Posted Date April 12, 2024
Actual Study Start Date August 10, 2020
Estimated Primary Completion Date August 30, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 11, 2024)		 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
Original Primary Outcome Measures
 (submitted: December 16, 2019)		 Genomic exploratory research [ Time Frame: 3 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
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 Analysis of Screen-detected Lung Cancers' Genomic Traits
Official Title Analysis of Screen-detected Lung Cancers' Genomic Traits
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.
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 Type Observational
Study Design Observational Model: Other
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:

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.
Sampling Method Non-Probability Sample
Study Population Screen detected lung cancer patients.
Condition Lung Cancer
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   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: April 11, 2024)		 526
Original Estimated Enrollment
 (submitted: December 16, 2019)		 427
Estimated Study Completion Date March 30, 2026
Estimated Primary Completion Date August 30, 2025   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 50 Years to 77 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Laura Hughes 0207 679 9284 ctc.ascent@ucl.ac.uk
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT04204499
Other Study ID Numbers 21919
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Current Responsible Party University College, London
Original Responsible Party Same as current
Current Study Sponsor University College, London
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Sam Janes UCL
PRS Account University College, London
Verification Date November 2023