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

NCT03452514 | Completed

• 1 other identifier: HMBDx USA-0001
• Study Type: observational
• Target: 479
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Cohort 1 - Low Dose CT (LDCT) Scan

Individuals undergoing their first or subsequent annual LDCT screening study

Cohort 2 - Diagnostic CT Scan

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

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Eligible for Lung Cancer Screening as per the National Lung Screening Trial (NLST) Guidelines

You may qualify if:

• Subject is undergoing LDCT screening for lung cancer.
• Subject is 55 to 80 years of age.
• Subject has a minimum 30 pack-year smoking history.
• Subject has not quit smoking more than 15 years ago.
• Subject is without symptoms attributable to lung cancer.
• Subject is able and willing to provide informed consent.

You may not qualify if:

• Subject has a history of lung, gastrointestinal, hematological, breast, thyroid, or genitourinary cancers within the past ten years.
• Subject is known to be infected with HIV, HBV, HCV, or tuberculosis or any other Biosafety Level 3 (BSL III) pathogen infections.

Sponsors & Collaborators

• Hummingbird Diagnostics: lead

Study Sites (4)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Lahey Hospital & Medical Center

Burlington, Massachusetts, 01805, United States

Location

Related Publications (1)

• Zyla J, Dziadziuszko R, Marczyk M, Sitkiewicz M, Szczepanowska M, Bottoni E, Veronesi G, Rzyman W, Polanska J, Widlak P. miR-122 and miR-21 are Stable Components of miRNA Signatures of Early Lung Cancer after Validation in Three Independent Cohorts. J Mol Diagn. 2024 Jan;26(1):37-48. doi: 10.1016/j.jmoldx.2023.09.010. Epub 2023 Oct 20.

  PMID: 37865291 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood will be drawn from all patients at the time of study enrollment prior to LDCT scanning (10cc blood divided into 2 PAXgene tubes)

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Amita Sharma, MD

  Massachusetts General Hospital

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: February 26, 2018
• First Posted: March 2, 2018
• Study Start: November 1, 2017
• Primary Completion: September 14, 2020
• Study Completion: September 15, 2020
• Last Updated: February 25, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)