Diagnostic Performance of Small RNA Blood Test in Patients Undergoing Follow-up Imaging After Positive Low Dose CT Screening for Cancer of the Lung
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| ClinicalTrials.gov Identifier: NCT05987189 |
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Recruitment Status :
Recruiting
First Posted : August 14, 2023
Last Update Posted : January 16, 2024
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Sponsor:
Hummingbird Diagnostics
Information provided by (Responsible Party):
Hummingbird Diagnostics
- Study Details
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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.
| Condition or disease | Intervention/treatment |
|---|---|
| Lung Cancer | Diagnostic Test: miLungDx |
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 |
| Estimated Enrollment : | 2000 participants |
| Observational Model: | Case-Only |
| Time Perspective: | Prospective |
| 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" |
| Actual Study Start Date : | October 18, 2023 |
| Estimated Primary Completion Date : | October 2024 |
| Estimated Study Completion Date : | December 2025 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Lung cancer
Drug Information
available for:
Ribonucleic acid
Intervention Details:
- 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.
Primary Outcome Measures :
- 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.
Biospecimen Retention: Samples With DNA
*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)
Information from the National Library of Medicine
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| Ages Eligible for Study: | 50 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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.
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
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): NCT05987189
Contacts
| Contact: Kaja Tikk | 4962219143355 | ktikk@hb-dx.com |
Locations
| United States, Georgia | |
| Northside Hospital | Recruiting |
| Atlanta, Georgia, United States, 30342 | |
| Contact: Lia Adderley 404-236-8336 lia.adderley@northside.com | |
| Principal Investigator: Howard Silverboard, MD | |
| United States, Massachusetts | |
| Mass General Brigham | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Contact: Alexandra Kunen 617-643-5886 akunen@mgh.harvard.edu | |
| Principal Investigator: Milena Petranovic, MD | |
| United States, Michigan | |
| Henry Ford Health | Recruiting |
| Detroit, Michigan, United States, 48202 | |
| Contact: Marie Tombrillo msauve1@hfhs.org | |
| Principal Investigator: Michael Simoff, MD | |
| United States, New York | |
| Jacobi Medical Center | Recruiting |
| Bronx, New York, United States, 10461 | |
| Contact: Raven Dwyer dwyerr1@nychh.org | |
| Principal Investigator: Malika Pradhan, MD | |
| New York Health + Hospitals | Recruiting |
| Bronx, New York, United States, 10461 | |
| Contact: Kanwal Latif 347-210-4279 latifk@nychhc.org | |
| Principal Investigator: Muhammad Perwaiz, MD | |
| United States, North Carolina | |
| Duke University Health System | Recruiting |
| Durham, North Carolina, United States, 27710 | |
| Contact: Elizabeth Mary Luck 919-684-7752 mary.luck@duke.edu | |
| Principal Investigator: Edwards Patz, MD | |
| United States, Texas | |
| Baptist Hospitals of Southeast Texas | Recruiting |
| Beaumont, Texas, United States, 77701 | |
| Contact: Samantha Blevins | |
| Contact: Sarah Morris | |
| Principal Investigator: Ernest Hymel, MD | |
| United States, Utah | |
| University Of Utah Health | Recruiting |
| Salt Lake City, Utah, United States, 84112 | |
| Contact: Robyn Barrus 801-581-5811 Robyn.Barrus@hsc.utah.edu | |
| Principal Investigator: Chakravarthy Reddy, MD | |
Sponsors and Collaborators
Hummingbird Diagnostics
| Responsible Party: | Hummingbird Diagnostics |
| ClinicalTrials.gov Identifier: | NCT05987189 |
| Other Study ID Numbers: |
Boston II |
| First Posted: | August 14, 2023 Key Record Dates |
| Last Update Posted: | January 16, 2024 |
| Last Verified: | January 2024 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| 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 |