Diagnostic Performance of Small RNA Blood Test in Patients Undergoing Follow-up Imaging After Positive Low Dose CT Screening for Cancer of the Lung

January 12, 2024 updated by: Hummingbird Diagnostics

Diagnostic Performance of Small RNA Blood Test in Patients Undergoing Follow-up Imaging After Positive Low Dose CT Screening for Cancer of the Lung "Early Detection of Lung Cancer Based on Small RNA Signatures - Boston II"

2,000 individuals, aged 50-80 who have received a lung-RADS category 3 or 4 result on a LDCT screening study and who are scheduled for follow-up diagnostic imaging study, biopsy, clinical consultation or surgical appointment at one of the participating hospitals.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The study is a prospective, longitudinal, observational study to evaluate the performance of a novel diagnostic test for early-stage lung cancer.

Study duration: Expected patient enrollment to be completed within 12 months after study initiation. Patients will be followed for a minimum of 12 months from the date of enrollment. The study duration is approximately 2 years.

Participant duration: The day of blood collection. Participants will follow their regular standard of care schedule as recommended by existing guidelines; no extra visits are planned. Follow up data will be obtained from the electronic medical record within at least 12 months of follow-up period.

Study Type

Observational

Enrollment (Estimated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Recruiting
        • Northside Hospital
        • Contact:
        • Principal Investigator:
          • Howard Silverboard, MD
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Mass General Brigham
        • Contact:
        • Principal Investigator:
          • Milena Petranovic, MD
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Health
        • Principal Investigator:
          • Michael Simoff, MD
        • Contact:
    • New York
      • Bronx, New York, United States, 10461
        • Recruiting
        • Jacobi Medical Center
        • Contact:
        • Principal Investigator:
          • Malika Pradhan, MD
      • Bronx, New York, United States, 10461
        • Recruiting
        • New York Health + Hospitals
        • Contact:
        • Principal Investigator:
          • Muhammad Perwaiz, MD
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke University Health System
        • Contact:
        • Principal Investigator:
          • Edwards Patz, MD
    • Texas
      • Beaumont, Texas, United States, 77701
        • Recruiting
        • Baptist Hospitals of Southeast Texas
        • Contact:
          • Samantha Blevins
        • Contact:
          • Sarah Morris
        • Principal Investigator:
          • Ernest Hymel, MD
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Recruiting
        • University of Utah Health
        • Contact:
        • Principal Investigator:
          • Chakravarthy Reddy, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Individuals, aged 50-80 who have received a lung-RADS category 3 or 4 result on a LDCT screening study and who are scheduled for follow-up diagnostic imaging study, biopsy, clinical consultation or surgical appointment at one of the participating hospitals.

Description

Inclusion Criteria:

  • Adult male and female patients, aged 50 to 80 years
  • Received a lung RADS category 3 or 4 finding on a LDCT screening exam (first or subsequent) and are referred to undergo further diagnostic procedures for the detection of lung cancer
  • Has undergone LD-CT screening exam within last 90 days and allows for blood sampling within this period
  • Subject may not have undergone any invasive diagnostic procedure in relation to the suspicious nodule
  • Able and willing to provide informed consent

Exclusion Criteria:

  • Prior history of diagnosed lung cancer
  • History of gastrointestinal, hematological, breast, thyroid, and genitourinary cancer within the past 10 years
  • Active infectious diseases, such blood borne viral diseases (e.g. AIDS, hepatitis)
  • Immunosuppressive medication
  • Deemed not able to participate in the study by the investigator

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Objective
Time Frame: 1 year
The study is a prospective, longitudinal, observational study to evaluate the performance of a novel diagnostic test for early-stage lung cancer. The primary endpoint is to detect the presence or absence of lung cancer, as determined by all follow-up imaging, and pathological data obtained throughout the duration of the study.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hummingbird Diagnostics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 18, 2023

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

April 26, 2023

First Submitted That Met QC Criteria

August 9, 2023

First Posted (Actual)

August 14, 2023

Study Record Updates

Last Update Posted (Estimated)

January 15, 2024

Last Update Submitted That Met QC Criteria

January 12, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Boston II

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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