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Active, Not Recruiting

NCT Number: NCT04968548

Determination and Validation of a Multi-analyte Assay for Lung Cancer Screening

This study is part of the development and validation of a non-invasive lung screening test which aim to identify early stage lung cancer in patients at high risk for lung cancer.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

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

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Calgary, Calgary, Alberta, Canada

Loading trial locations.

About this study

This is a prospective, case-control, multi-center, observational nonsignificant risk study. The study aims to collect blood and clinical data from subjects undergoing Low Dose CT (LDCT) for lung cancer screening and subjects with confirmed lung cancer.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

- Cases:

  • Current or past smokers, with at least 20 pack-years
  • Subjects with either A high suspicion for lung cancer, with planned surgery to establish a definitive diagnosis within 60 days after date of blood collection OR treatment naive lung cancer patients

Exclusion criteria

- Cases:

  • Known diagnosis or treatment of any previous cancer, including lung cancer, in the past 5 years, except for fully resected non-melanoma skin cancer or fully-resected carcinoma in situ of the cervix
  • Current lung cancer is known to be stage III or IV by pathology.

Inclusion criteria

- Screening:

  • Current or past smokers, with at least 20 pack-years, undergoing LDCT for lung cancer screening

Exclusion criteria

- Screening:

  • Known diagnosis or treatment of any cancer, including lung cancer, in the past 5 years, except for fully resected non-melanoma skin cancer or fully-resected carcinoma in situ of the cervix
  • Subjects whose purpose of performing LDCT is for surveillance of a lung nodule

Treatment and study plan

Blood Collection

Procedure

Peripheral blood will be collected via routine venipuncture procedure

Primary outcomes

  1. Collection of blood samples

    Time frame: 24 Months

    Collect blood to support the development and validation of a multi analyte test for lung cancer screening

  2. Clinical data collection

    Time frame: 24 Months

    Collect clinical data to support the development and validation of a multi analyte test for lung cancer screening

Secondary outcomes

  1. Performance

    Time frame: 36 Months

    Performance of the assay in terms of (1) Sensitivity (2) Specificity (3) NPV (negative predictive value) and (4) PPV (positive predictive value)

  2. Sensitivity

    Time frame: 36 Months

    Performance of the assay in terms of Sensitivity

  3. Specificity

    Time frame: 36 Months

    Performance of the assay in terms of Specificity

  4. Negative Predictive Value

    Time frame: 36 Months

    Performance of the assay in terms of NPV (negative predictive value)

  5. Positive Predictive Value

    Time frame: 36 Months

    Performance of the assay in terms of PPV (positive predictive value)

Sponsors and collaborators

Lead sponsor

Nucleix Ltd.

Industry

Registry information

Official study title

Determination and Validation of Lung EpiCheck®: A Multianalyte Assay for Lung Cancer Prediction. A Case-Control Study

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Jul 20, 2021
Registry last updated
Nov 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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