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NCT04204499 Clinical Trial

Analysis of Screen-detected Lung Cancers' Genomic Traits

Lung Cancer Clinical Trial

— ASCENT  

Official title:
Analysis of Screen-detected Lung Cancers' Genomic Traits

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04204499
Other study ID # 21919
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 10, 2020
Est. completion date March 30, 2026

Study information
Verified date November 2023
Source University College, London
Contact Laura Hughes
Phone 0207 679 9284
Email ctc.ascent@ucl.ac.uk
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 526
Est. completion date March 30, 2026
Est. primary completion date August 30, 2025
Accepts healthy volunteers No
Gender All
Age group 50 Years to 77 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United Kingdom St Bart's Hospital London
United Kingdom UCLH London

Sponsors (1)
Lead Sponsor Collaborator
University College, London

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Genomic exploratory research 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 4 years
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