NCT04204499

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
526

participants targeted

Target at P75+ for all trials

Timeline
3mo left

Started Aug 2020

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress97%
Aug 2020Jul 2026

First Submitted

Initial submission to the registry

December 11, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 19, 2019

Completed
8 months until next milestone

Study Start

First participant enrolled

August 10, 2020

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2026

Last Updated

May 14, 2026

Status Verified

May 1, 2026

Enrollment Period

6 years

First QC Date

December 11, 2019

Last Update Submit

May 11, 2026

Conditions

Lung Cancer

Keywords

Genomic signaturesScreen-detected cancerNon-invasive biological and radiological parameters

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age50 Years - 77 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Screen detected lung cancer patients.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

St Bart's Hospital

London, EC1A 7BE, United Kingdom

Location

UCLH

London, NW1 2BU, United Kingdom

Location

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.

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Sam Janes

    UCL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 11, 2019

First Posted

December 19, 2019

Study Start

August 10, 2020

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

July 31, 2026

Last Updated

May 14, 2026

Record last verified: 2026-05

Locations

GB(2)