Addition of microRNA Blood Test to Lung Cancer Screening Low Dose CT

Lung Cancer Clinical Trial

Official title:

Prospective Longitudinal Blinded Observational Diagnostic Study - Addition of microRNA Blood Test to Lung Cancer Screening Low Dose CT

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03452514
• Other study ID #: HMBDx USA-0001
• Status: Completed
• Start date: November 1, 2017
• Est. completion date: September 15, 2020

Study information

• Verified date: February 2021
• Source: Hummingbird Diagnostics
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To demonstrate that the specificity of the Hummingbird microRNA profile for the diagnosis of lung cancer in a cohort of patients who meet current eligibility criteria for lung cancer screening in the U.S. is superior to the specificity of LDCT.

Description:

This is a prospective, longitudinal, blinded, observational diagnostic study on 400 individuals undergoing lung cancer screening with low-dose computed tomography (LDCT).

There will be two patient cohorts: Cohort 1: individuals undergoing their first or subsequent annual LDCT screening study; and Cohort 2: individuals referred for a follow-up diagnostic chest CT scan due to a lung-RADS category 3 or 4 result on a previous LDCT scan.

At study enrollment a blood sample will be drawn prior to the LDCT scan. On this blood sample a novel lung cancer test relying on microRNA signatures will be evaluated. The results will be compared with the CT scan results and follow-up tests including pathology. Histologic results and follow-up data will be collected on all patients for a minimum of 12 months post-enrollment. During the follow-up period, the results of all diagnostic chest CT scans, lung biopsies or lung resections will be captured from the Partners electronic medical record and entered into the case report form (CRF).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 479
• Est. completion date: September 15, 2020
• Est. primary completion date: September 14, 2020
• Gender: All
• Age group: 55 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Subject is undergoing LDCT screening for lung cancer.

2. Subject is 55 to 80 years of age.

3. Subject has a minimum 30 pack-year smoking history.

4. Subject has not quit smoking more than 15 years ago.

5. Subject is without symptoms attributable to lung cancer.

6. Subject is able and willing to provide informed consent.

Exclusion Criteria:

1. Subject has a history of lung, gastrointestinal, hematological, breast, thyroid, or genitourinary cancers within the past ten years.

2. Subject is known to be infected with HIV, HBV, HCV, or tuberculosis or any other Biosafety Level 3 (BSL III) pathogen infections.

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Lahey Hospital & Medical Center	Burlington	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Hummingbird Diagnostics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Specificity of HMBDx microRNA Test for Lung Cancer	The reference standard will be the combination of all available diagnostic information (LDCT, subsequent diagnostic imaging studies, biopsy results and surgical pathology results) obtained during at least 12 months of follow-up.	12 months