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

Sponsor
Nucleix Ltd. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04968548
Collaborator
(none)
5,000
20
30.5
250
8.2

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Blood collection

Detailed Description

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
5000 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Determination and Validation of Lung EpiCheck®: A Multianalyte Assay for Lung Cancer Prediction. A Case-Control Study
Actual Study Start Date :
Sep 17, 2021
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Apr 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Cases Series

Subjects with confirmed lung cancer diagnosis

Procedure: Blood collection
Peripheral blood will be collected via routine venipuncture procedure

Screening Series

Subjects undergoing LDCT for lung cancer screening

Procedure: Blood collection
Peripheral blood will be collected via routine venipuncture procedure

Outcome Measures

Primary Outcome Measures

  1. Collection of blood samples [24 Months]

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

  2. Clinical data collection [24 Months]

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

Secondary Outcome Measures

  1. Performance [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 [36 Months]

    Performance of the assay in terms of Sensitivity

  3. Specificity [36 Months]

    Performance of the assay in terms of Specificity

  4. Negative Predictive Value [36 Months]

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

  5. Positive Predictive Value [36 Months]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 80 Years
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 VA Connecticut Healthcare System West Haven Connecticut United States 06516
2 Orlando Health, Inc. Orlando Florida United States 32806
3 Sarasota Memorial Hospital Sarasota Florida United States 34239
4 St. Elizabeth Edgewood Hospital Edgewood Kentucky United States 41017
5 Norton Cancer Institute Louisville Kentucky United States 40202
6 Johns Hopkins Medical Center Baltimore Maryland United States 21287
7 Lahey Hospital and Medical Center Burlington Massachusetts United States 01805
8 Harry S. Truman Memorial Veterans' Hospital Columbia Missouri United States 65201
9 Washington University in St. Louis Saint Louis Missouri United States 63110
10 The University of North Carolina Chapel Hill North Carolina United States 27599
11 Duke University Durham North Carolina United States 27705
12 Durham VA Health Care System Durham North Carolina United States 27710
13 Novant Health Cancer Research Winston-Salem North Carolina United States 27103
14 Summa Health Akron Ohio United States 44304
15 Cleveland Clinic Foundation Cleveland Ohio United States 44106
16 Ralph H. Johnson VA Medical Center Charleston South Carolina United States 29401
17 Medical University of South Carolina (MUSC) Charleston South Carolina United States 29425
18 Michael E. DeBakey VA Medical Center Houston Texas United States 77030
19 Vancouver General Hospital/The University of British Columbia Vancouver British Columbia Canada V5Z 1M9
20 University Health Network Toronto Ontario Canada M5G 2C4

Sponsors and Collaborators

  • Nucleix Ltd.

Investigators

  • Study Director: Aharona Shuali, MD, Nucleix Ltd.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Nucleix Ltd.
ClinicalTrials.gov Identifier:
NCT04968548
Other Study ID Numbers:
  • Lung-RND-003
First Posted:
Jul 20, 2021
Last Update Posted:
Jul 6, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Nucleix Ltd.
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 6, 2022