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

NCT04629079 | Unknown DMC

• 1 other identifier: 261766
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lung Cancer

Keywords

Early detection

Outcome Measures

Primary Outcomes (1)

• 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.

  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 Outcomes (2)

• 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.

  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.

  Through study completion, an average of 2 years.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Synchronous other cancer types.

Sponsors & Collaborators

• King's College London: lead

Study Sites (1)

Borthwick Research Unit, Lister Hospital

Stevenage, SG1 4AB, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples processed for serum, plasma and PBMC extraction

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Thida Win, MD

  Lister Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carina Cruz, MRes

CONTACT

01438 284435; carina.cruz@nhs.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2020
• First Posted: November 16, 2020
• Study Start: October 23, 2020
• Primary Completion: October 23, 2022
• Study Completion: October 23, 2024
• Last Updated: November 16, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)