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

• ClinicalTrials.gov Identifier: NCT05987189
• Recruitment Status: Recruiting
• First Posted: August 14, 2023
• Last Update Posted: January 16, 2024
• Sponsor: Hummingbird Diagnostics
• Information provided by (Responsible Party): Hummingbird Diagnostics

Tracking Information

• First Submitted Date: April 26, 2023
• First Posted Date: August 14, 2023
• Last Update Posted Date: January 16, 2024
• Actual Study Start Date: October 18, 2023
• Estimated Primary Completion Date: October 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 9, 2023)

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.

• Original Primary Outcome Measures: Same as current
• 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: Diagnostic Performance of Small RNA Blood Test in Patients Undergoing Follow-up Imaging After Positive Low Dose CT Screening for Cancer of the Lung
• Official Title: 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"
• Brief Summary: 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.

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
• Study Design: Observational Model: Case-Only; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided

Biospecimen

Retention:   Samples With DNA

Description:

*Blood sample (2x2,5 ml blood in PAXgene® tubes, 1x10 ml Streck® RNA Complete BCT CE blood, 1x10 ml Streck® Cell-free DNA BCT CE blood)

• 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.
• Condition: Lung Cancer

Intervention

Diagnostic Test: miLungDx

At study enrollment a blood sample will be drawn prior to any invasive diagnostic study or treatment. On this blood sample a novel lung cancer test relying on small RNA signatures will be performed and evaluated.

• Study Groups/Cohorts: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: August 9, 2023): 2000
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2025
• Estimated Primary Completion Date: October 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 50 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Kaja Tikk; 4962219143355; ktikk@hb-dx.com

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05987189
• Other Study ID Numbers: Boston II
• 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

• Current Responsible Party: Hummingbird Diagnostics
• Original Responsible Party: Same as current
• Current Study Sponsor: Hummingbird Diagnostics
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Hummingbird Diagnostics
• Verification Date: January 2024