Solitary Pulmonary NoduleNCT05171491
LungLB in Subjects Presenting With Indeterminate Pulmonary Nodules
An observational study of Solitary Pulmonary Nodule and Multiple Pulmonary Nodules, run by LungLife AI at 12 sites in United States.
Trial summary
Correlate performance of LungLB Test with outcome of a scheduled biopsy. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Solitary Pulmonary Nodule, Multiple Pulmonary Nodules
- How many people
- 425 participants
- Where
- 12 sitesUnited States
- Study dates
- 26 Jan 2022to 2 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with suspicious indeterminate pulmonary nodules identified incidentally or through a lung cancer screening program. up to 15 institutions geographically distributed across the US.
Who may be able to join
- At least 18 years old with a CT identified indeterminate pulmonary nodule and scheduled for biopsy, at the time of consent.
- Planned biopsy nodule of interest:
- is solid ≤3 cm; or
- is nonsolid, ground glass opacity, of any size; or
- is part solid, where the solid component is no larger than 3cm (maximum diameter).
Who cannot join
- Current and or prior diagnosis +/- treatment of non-lung cancer within the past 3 years.
- Current and or prior lung cancer diagnosis within 2 years following intent-to-cure surgery.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Clinical Site 05
Bay Pines, Florida, 33744
Clinical Site 25
Columbia, South Carolina, 29203
Clinical Site 07
Hines, Illinois, 60141
Clinical Site 02
Houston, Texas, 77030
Clinical Site 27
Kansas City, Kansas, 64111
Clinical Site 08
Kansas City, Missouri, 64128
Clinical Site 04
Los Angeles, California, 90095
Clinical Site 03
Miami, Florida, 33136
Clinical Site 32
Milwaukee, Wisconsin, 53295
Clinical Site 01
New York, New York, 10029
Clinical Site 18
Reno, Nevada, 89502
Clinical Site 12
Wichita, Kansas, 67218
About this study
Official title: Clinical Evaluation of LungLB in Subjects Presenting With Indeterminate Pulmonary Nodules
Correlate performance of LungLB Test with outcome of a scheduled biopsy.
- Keywords
- Lung Cancer, Circulating Genetically Abnormal Cells (CGAC), 4-color FISH, Increased/Decreased Risk, Early Lung Cancer Detection, Indeterminate Nodule
- Medical subject headings
- Solitary Pulmonary Nodule, Multiple Pulmonary Nodules, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Indeterminate Lung Nodule | Subjects that present with indeterminate lung nodules at time of biopsy. No intervention outside of standard of care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of LungLB test as compared to results from a tissue/FNA biopsy.
Measured: up to 60 days
Secondary outcomes (1)
Evaluate Clinical Variables With and Without LungLB Test Results
Evaluate the independent and associated contribution of readily available clinical variables including age, race, gender, socioeconomic level, environmental exposure, tobacco use, and radiology data combined with and without the LungLB test results and correlate with biopsy (tissue / FNA) outcome of indeterminate pulmonary nodules.
Measured: up to 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2021
- Study start26 Jan 2022
- Primary completion30 Dec 2023
- Study completion2 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solitary Pulmonary NoduleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 425 participants (actual)
Sponsor and investigators
- Lead sponsor
- LungLife AI
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Donovan, MD, Study director, LungLife AI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05171491
- Sponsor's protocol ID
- LAI-001
- Status last verified
- Jun 2024
- First submitted
- 12 Nov 2021
- Last updated
- 13 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of LungLB in Subjects Presenting With Indeterminate Pulmonary Nodules
- ClinicalTrials.gov ID
- NCT05171491
- Acronym / sponsor ID
- LAI-001
- Keywords
- Lung Cancer, Circulating Genetically Abnormal Cells (CGAC), 4-color FISH, Increased/Decreased Risk, Early Lung Cancer Detection, Indeterminate Nodule
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 425 participants (actual)
- Lead sponsor
- LungLife AIIndustry (pharma, biotech, devices)
- Study start
- 26 Jan 2022 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 2 Sep 2024 (estimated)
- First posted
- 29 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Correlate performance of LungLB Test with outcome of a scheduled biopsy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Indeterminate Lung Nodule | – | –Subjects that present with indeterminate lung nodules at time of biopsy. No intervention outside of standard of care. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with suspicious indeterminate pulmonary nodules identified incidentally or through a lung cancer screening program. up to 15 institutions geographically distributed across the US.
Key inclusion criteria (5 listed)
- At least 18 years old with a CT identified indeterminate pulmonary nodule and scheduled for biopsy, at the time of consent.
- Planned biopsy nodule of interest:
Key exclusion criteria (2 listed)
- Current and or prior diagnosis +/- treatment of non-lung cancer within the past 3 years.
- Current and or prior lung cancer diagnosis within 2 years following intent-to-cure surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sensitivity and specificity of LungLB test as compared to results from a tissue/FNA biopsy.
Time frame: up to 60 days
1 secondary outcome
Evaluate Clinical Variables With and Without LungLB Test Results
Time frame: up to 60 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Donovan, MD study director
LungLife AI
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Solitary Pulmonary Nodule and Multiple Pulmonary Nodules, run by LungLife AI at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity of LungLB test as compared to results from a tissue/FNA biopsy. (time frame: up to 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2024.