History of Changes for Study: NCT05987189

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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Study Record Versions

Version	Submitted Date	Changes
1	August 9, 2023	None (earliest Version on record)
2	October 23, 2023	Recruitment Status, Study Status, Oversight and Contacts/Locations
3	January 12, 2024	Contacts/Locations and Study Status

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Merged
Side-by-Side

Study Identification


Unique Protocol ID:	Boston II
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"
Secondary IDs:

Study Status


Record Verification:	August 2023
Overall Status:	Not yet recruiting
Study Start:	September 2023
Primary Completion:	October 2024 [Anticipated]
Study Completion:	December 2025 [Anticipated]

First Submitted:	April 26, 2023
First Submitted that Met QC Criteria:	August 9, 2023
First Posted:	August 14, 2023 [Actual]

Last Update Submitted that Met QC Criteria:	August 9, 2023
Last Update Posted:	August 14, 2023 [Actual]

Sponsor/Collaborators


Sponsor:	Hummingbird Diagnostics
Responsible Party:	Sponsor
Collaborators:

Oversight


U.S. FDA-regulated Drug:	No
U.S. FDA-regulated Device:	No
Data Monitoring:	Yes

Study Description

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.

Conditions


Conditions:	Lung Cancer
Keywords:

Study Design


Study Type:	Observational
Observational Study Model:	Case-Only
Time Perspective:	Prospective
Biospecimen Retention:	Samples With DNA
Biospecimen 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)
Enrollment:	2000 [Anticipated]
Number of Groups/Cohorts	0

Groups and Interventions


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.

Outcome Measures


Primary Outcome Measures:
1.	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.

Eligibility


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.
Sampling Method:	Non-Probability Sample
Minimum Age:	50 Years
Maximum Age:	80 Years
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
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

Contacts/Locations


Central Contact Person:	Jose Ramirez, BS Telephone: 06022910792 Email: jose.ramirez@allucent.com
Locations:

IPDSharing


Plan to Share IPD:	No

References


Citations:
Links:
Available IPD/Information: