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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03452514
Recruitment Status : Completed
First Posted : March 2, 2018
Last Update Posted : February 25, 2021
Sponsor:
Information provided by (Responsible Party):
Hummingbird Diagnostics

Study Description
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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.

Condition or disease
Lung Cancer

Detailed 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).

Study Design
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Study Type : Observational
Actual Enrollment : 479 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Longitudinal Blinded Observational Diagnostic Study - Addition of microRNA Blood Test to Lung Cancer Screening Low Dose CT
Actual Study Start Date : November 1, 2017
Actual Primary Completion Date : September 14, 2020
Actual Study Completion Date : September 15, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Groups and Cohorts
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Group/Cohort
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


Outcome Measures
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Primary Outcome Measures :
  1. Specificity of HMBDx microRNA Test for Lung Cancer [ Time Frame: 12 months ]
    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.


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)

Eligibility Criteria
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Ages Eligible for Study:   55 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Eligible for Lung Cancer Screening as per the National Lung Screening Trial (NLST) Guidelines
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03452514


Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Lahey Hospital & Medical Center
Burlington, Massachusetts, United States, 01805
Sponsors and Collaborators
Hummingbird Diagnostics
Investigators
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Study Director: Amita Sharma, MD Massachusetts General Hospital
More Information
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Responsible Party: Hummingbird Diagnostics
ClinicalTrials.gov Identifier: NCT03452514    
Other Study ID Numbers: HMBDx USA-0001
First Posted: March 2, 2018    Key Record Dates
Last Update Posted: February 25, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases