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

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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

Tracking Information
First Submitted Date February 26, 2018
First Posted Date March 2, 2018
Last Update Posted Date February 25, 2021
Actual Study Start Date November 1, 2017
Actual Primary Completion Date September 14, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 26, 2018)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Addition of microRNA Blood Test to Lung Cancer Screening Low Dose CT
Official Title Prospective Longitudinal Blinded Observational Diagnostic Study - Addition of microRNA Blood Test to Lung Cancer Screening Low Dose CT
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.
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Blood will be drawn from all patients at the time of study enrollment prior to LDCT scanning (10cc blood divided into 2 PAXgene tubes)
Sampling Method Non-Probability Sample
Study Population Eligible for Lung Cancer Screening as per the National Lung Screening Trial (NLST) Guidelines
Condition Lung Cancer
Intervention Not Provided
Study Groups/Cohorts
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 27, 2020)
479
Original Estimated Enrollment
 (submitted: February 26, 2018)
400
Actual Study Completion Date September 15, 2020
Actual Primary Completion Date September 14, 2020   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 55 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03452514
Other Study ID Numbers HMBDx USA-0001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Hummingbird Diagnostics
Study Sponsor Hummingbird Diagnostics
Collaborators Not Provided
Investigators
Study Director: Amita Sharma, MD Massachusetts General Hospital
PRS Account Hummingbird Diagnostics
Verification Date February 2021