Lung Cancer Clinical Trial

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

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.

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Full 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.

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Eligibility Criteria

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

Study is for people with:

Lung Cancer

Estimated Enrollment:

5000

Study ID:

NCT04968548

Recruitment Status:

Recruiting

Sponsor:

Nucleix Ltd.

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There are 22 Locations for this study

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VA Connecticut Healthcare System
West Haven Connecticut, 06516, United States
Orlando Health, Inc.
Orlando Florida, 32806, United States
Sarasota Memorial Hospital
Sarasota Florida, 34239, United States
St. Elizabeth Edgewood Hospital
Edgewood Kentucky, 41017, United States
Norton Cancer Institute
Louisville Kentucky, 40202, United States
Johns Hopkins Medical Center
Baltimore Maryland, 21287, United States
Lahey Hospital and Medical Center
Burlington Massachusetts, 01805, United States
Harry S. Truman Memorial Veterans' Hospital
Columbia Missouri, 65201, United States
Washington University in St. Louis
Saint Louis Missouri, 63110, United States
University of Rochester
Rochester New York, 14627, United States
The University of North Carolina
Chapel Hill North Carolina, 27599, United States
Duke University
Durham North Carolina, 27705, United States
Durham VA Health Care System
Durham North Carolina, 27710, United States
W.G. (Bill) Hefner VA Medical Center
Salisbury North Carolina, 28144, United States
Novant Health Cancer Research
Winston-Salem North Carolina, 27103, United States
Summa Health
Akron Ohio, 44304, United States
Cleveland Clinic Foundation
Cleveland Ohio, 44106, United States
Ralph H. Johnson VA Medical Center
Charleston South Carolina, 29401, United States
Medical University of South Carolina (MUSC)
Charleston South Carolina, 29425, United States
Michael E. DeBakey VA Medical Center
Houston Texas, 77030, United States
Vancouver General Hospital/The University of British Columbia
Vancouver British Columbia, V5Z 1, Canada
University Health Network
Toronto Ontario, M5G 2, Canada

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Estimated Enrollment:

5000

Study ID:

NCT04968548

Recruitment Status:

Recruiting

Sponsor:


Nucleix Ltd.

How clear is this clinincal trial information?

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