Improving the Early Detection of Lung Cancer by Combining Exosomal Analysis of Hypoxia With Standard of Care Imaging (LungExoDETECT)

November 13, 2020 updated by: King's College London

Lung Cancer Detection Using Blood Exosomes and HRCT- Improving the Early Detection of Lung Cancer by Combining Exosomal Analysis of Hypoxia With Standard of Care Imaging

This project aims to validate exosomal assays that are based on hypoxia detection as potential biomarkers of early detection. The study analysis will determine whether the assay can detect clinical lung cancer at the time of imaging and interval cancers during subsequent follow up. The study aims to establish preliminary sensitivity/specificity data for the "combined CT/exosomal risk stratification marker" and provide initial data on the potential association of the "combined CT/exosomal risk score" with the subsequent cancer progression and treatment response.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Lung cancer is the leading cause of cancer deaths. Screening for early detection of cancer at an early stage reduces cancer deaths and therefore improves prognosis. The National Lung Screening Trial (NLST), for instance, showed that CT screening increases the early detection rate, and reduces mortality. However, drawbacks include over-diagnosis, false-positive results, psychological distress and cost. Therefore, lung cancer screening is not recommended or available within the NHS.

Diagnosis of lung cancer is currently based on a combination of scans and tissue biopsy. The invasive nature of current diagnostic procedures limits their application. To improve the efficacy and cost effectiveness of screening in early detection of lung cancer, additional, complementary and non-invasive methods, such as circulating biomarkers, should be evaluated. Our novel exosomal assay (taken from a blood sample) when combined with CT, may improve the current accuracy of lung cancer detection, especially that of a worse clinical prognosis. Improvement in the accuracy of detection and/or prediction of future disease by performing the combined imaging exosome test will cause a paradigm shift. Moving towards the identification of blood tests can help increase confidence about follow-up decisions and shorten the interval before biopsy.

This prospective cohort study will recruit patients referred to secondary care for the investigation of clinical symptoms or signs suspicious of lung cancer.

The study will run between 2020 and 2024 (two-year active recruitment and two-year follow up).

Participants will have a single assay of blood taken on one occasion in the lung clinic by trained staff.

Participants will have normal standard of care chest CT scans and this data will be used.

All participants will be actively followed for 3 months and then those with nodules, revealed by CT Scan, at 3 monthly intervals. Longitudinal clinical data will be collected on the investigations, diagnoses and outcomes of all study patients.

Data will be collected on date, type and results of imaging and biopsy investigations including nodule size and progression.

For those diagnosed with lung cancer, data on tumour size, stage, type and other markers) will be recorded together with treatment response and date of death, where this occurs within the study.

Study Type

Observational

Enrollment (Anticipated)

800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United Kingdom
      • Stevenage, United Kingdom, SG1 4AB
        • Recruiting
        • Borthwick Research Unit, Lister Hospital
        • Contact:
          • Carina Cruz, MRes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study will include patients who have been referred to the Lung Cancer Clinic and Multi- Disciplinary Team (MDT) at The Lister, Hertford County and New QEII Hospitals for investigation of suspected lung cancer.

Description

Inclusion Criteria:

  • Over 18 years of age
  • Suspected clinical diagnosis of lung cancer
  • Able to provide informed consent

Exclusion Criteria:

-Synchronous other cancer types.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Describe the range of exosomal expression of P4HA1 in participants being clinically assessed for a suspected lung cancer diagnosis and compare the range of expression between the cancer and non-cancer participant population.
Time Frame: Through study completion, an average of 2 years.
Describe the expression of hypoxia- response element (HRE) responsible protein P4HA1 utilising a hypoxia-reporting cancer exosomal assay in participants being clinically assessed for suspected lung cancer.
Through study completion, an average of 2 years.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Describe the range of expression of precursor microRNA in exosomes derived from participants being clinically assessed for suspected lung cancer and compare the range of expression between the cancer and non-cancer participant population.
Time Frame: Through study completion, an average of 2 years.
Utilise exosome-based assessment of pre-microRNA processing to inform the development of a hypoxia gene signature for the early detection of lung cancer.
Through study completion, an average of 2 years.
Develop a combined risk score combining multi-dimensional parameters to discriminate between cancer cases and non-cancer cases.
Time Frame: Through study completion, an average of 2 years.
To develop a combined risk prediction model to support the early diagnosis of lung cancer.
Through study completion, an average of 2 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King's College London

Investigators

  • Principal Investigator: Thida Win, MD, Lister Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 23, 2020

Primary Completion (Anticipated)

October 23, 2022

Study Completion (Anticipated)

October 23, 2024

Study Registration Dates

First Submitted

October 30, 2020

First Submitted That Met QC Criteria

November 13, 2020

First Posted (Actual)

November 16, 2020

Study Record Updates

Last Update Posted (Actual)

November 16, 2020

Last Update Submitted That Met QC Criteria

November 13, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 261766

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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