This is the classic website, which will be retired eventually. Please visit the modernized ClinicalTrials.gov instead.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05987189
Recruitment Status : Recruiting
First Posted : August 14, 2023
Last Update Posted : January 16, 2024
Sponsor:
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
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 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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
Removed Location Countries  
 
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