Analysis of Screen-detected Lung Cancers' Genomic Traits

Recruiting

• Conditions: Lung Cancer

• Registration Number: NCT04204499
• Lead Sponsor: University College, London

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 Timeline

• Study First Submitted: 2019-12-11
• Study First Submitted QC: 2019-12-16
• Study First Posted: 2019-12-19
• Study Start: 2020-08-10
• Status Verified: 2023-11
• Last Update Submitted: 2024-04-11
• Last Update Posted: 2024-04-12
• Primary Completion: 2025-08-30
• Study Completion: 2026-03-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 526

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Genomic exploratory research	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

Trial Locations

Locations (2)

St Bart's Hospital; 🇬🇧 London, United Kingdom

UCLH; 🇬🇧 London, United Kingdom