Lung NodulesCLARIFYNCT06728319
A Multicenter, Retrospective, Chart Review Study Evaluating the Impact and Utility of the Blood-Based Proteomic Integrated Classifier and Auto-Antibody Tests in the Real-World
An observational study of Lung Nodules, run by Biodesix, Inc. at 5 sites in United States.
Trial summary
This study is a multicenter retrospective chart review. Sites with at least 100 patients tested with the IC and AAT tests, who have index dates (date of IC and AAT testing) at least one year prior to data collection date will be eligible for participation. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Lung Nodules
- How many people
- 4,000 participants
- Where
- 5 sitesUnited States
- Study dates
- 19 Sep 2024to 31 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Patients that have previously been tested with the AAT and IC tests and have at least 1 year of follow up data.
Who may be able to join
- Patients treated at sites with ≥100 patients who have been evaluated with the IC and AAT tests.
- Patients who are at least 40 years of age on the index date.
- Patients who have index dates (date of IC and AAT testing) at least one year prior to data collection date.
Who cannot join
- Patients with no prior AAT and/or IC testing at the study site.
- Patients less than 40 years of age on the index date.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Pulmonary & Sleep of Tampa Bay
Brandon, Florida, 33511
The Lung Center, PC
DuBois, Pennsylvania, 15801
Southcoast Health System
Fairhaven, Massachusetts, 02720
White-Wilson Medical Center
Fort Walton Beach, Florida, 32548
The Lung and Sleep Disorder Institute
Somerset, Kentucky, 42503
About this study
This study is a multicenter retrospective chart review. Sites with at least 100 patients tested with the IC and AAT tests, who have index dates (date of IC and AAT testing) at least one year prior to data collection date will be eligible for participation.
Read the detailed description
This study is a multicenter retrospective chart review. Sites with at least 100 patients tested with the IC and AAT tests, who have index dates (date of IC and AAT testing) at least one year prior to data collection date will be eligible for participation.
The protocol will require institutional IRB approval and a waiver of patient consent will be obtained. The data to be collected will be de-identified when entered into the study database. The collection of this de-identified data does not pose any risk to the subjects and does not require any further testing of the patient. The chart review will utilize a third-party Clinical Research Associate (CRA) with certified ICH-GCP training for data collection and documentation. Biodesix, Inc. in conjunction with the CRA will develop and maintain the Electronic Data Capture (EDC) system.
- Conditions
- Lung Nodules
- Keywords
- Lung nodule, Pulmonology
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess Test Performance of AAT test
To assess the performance of the AAT test in a real-world patient population:
- Sensitivity of the AAT test at 24 months
- Specificity of the AAT test at 24 months
- Positivity predictive value of the AAT test at 24 months
Measured: Up to 24 months
Assess Test Performance of IC test
To assess the performance of the IC test in a real-world population:
- Sensitivity of the IC test at 24 months
- Specificity of the IC test at 24 months
- Negative predictive value of the IC test at 24 months
Measured: 24 months
Assess serial performance of serial testing with the AAC and IC tests.
Assess the performance of the of serial testing with the AAC and IC tests
Measured: 24 months
Secondary outcomes (2)
Assess ATT Test Accuracy
To assess the accuracy of the AAT post-test risk of malignancy by comparing with the actual patient outcome.
- Compare the AAT test predicted proportion of malignant nodules to the actual proportion of malignant nodules by probability decile.
- Compare the IC test predicted proportion of malignant nodules to the actual proportion of malignant nodules by probability decile.
Measured: Up to 24 months
Determine Health Outcomes
To determine one-year health outcomes of patients stratified by AAT and IC tests result risk categories.
- The number and type of invasive diagnostic procedure performed on newly identified nodules stratified by AAT test results.
- The number of patients routed to CT surveillance following initial nodule evaluation that result in nodule resolution or up to 24-month radiographic stability stratified by the AAT test.
- The number and type of invasive diagnostic procedures performed on newly identified nodules stratified by IC test results.
- The number of patients routed to CT surveillance following initial nodule evaluation that result in nodule resolution or up to 24-month radiographic stability stratified by the IC test.
- The number of malignant nodules identified following a diagnostic procedure stratified by histology and stage.
- The number of specific benign nodules identified following a diagnostic procedure, stratified by pathological findings.
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2024
- Study start19 Sep 2024
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung NodulesStudies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biodesix, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- James Jett, MD, Principal investigator, Biodesix, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06728319
- Sponsor's protocol ID
- BDSX-CD-011
- Acronym
- CLARIFY
- Status last verified
- Feb 2025
- First submitted
- 4 Oct 2024
- Last updated
- 7 Feb 2025
- 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 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Retrospective, Chart Review Study Evaluating the Impact and Utility of the Blood-Based Proteomic Integrated Classifier and Auto-Antibody Tests in the Real-World
- ClinicalTrials.gov ID
- NCT06728319
- Acronym / sponsor ID
- CLARIFY / BDSX-CD-011
- Conditions
- Lung Nodules
- Keywords
- Lung nodule, Pulmonology
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Biodesix, Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Sep 2024 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 11 Dec 2024 (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.
This study is a multicenter retrospective chart review. Sites with at least 100 patients tested with the IC and AAT tests, who have index dates (date of IC and AAT testing) at least one year prior to data collection date will be eligible for participation.
Detailed description
This study is a multicenter retrospective chart review. Sites with at least 100 patients tested with the IC and AAT tests, who have index dates (date of IC and AAT testing) at least one year prior to data collection date will be eligible for participation.
The protocol will require institutional IRB approval and a waiver of patient consent will be obtained. The data to be collected will be de-identified when entered into the study database. The collection of this de-identified data does not pose any risk to the subjects and does not require any further testing of the patient. The chart review will utilize a third-party Clinical Research Associate (CRA) with certified ICH-GCP training for data collection and documentation. Biodesix, Inc. in conjunction with the CRA will develop and maintain the Electronic Data Capture (EDC) system.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients that have previously been tested with the AAT and IC tests and have at least 1 year of follow up data.
Key inclusion criteria (3 listed)
- Patients treated at sites with ≥100 patients who have been evaluated with the IC and AAT tests.
- Patients who are at least 40 years of age on the index date.
- Patients who have index dates (date of IC and AAT testing) at least one year prior to data collection date.
Key exclusion criteria (2 listed)
- Patients with no prior AAT and/or IC testing at the study site.
- Patients less than 40 years of age on the index date.
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
Assess Test Performance of AAT test
Time frame: Up to 24 months
To assess the performance of the AAT test in a real-world patient population: 1. Sensitivity of the AAT test at 24 months 2. Specificity of the AAT test at 24 months 3. Positivity predictive value of the AAT test at 24 months
Assess Test Performance of IC test
Time frame: 24 months
To assess the performance of the IC test in a real-world population: 1. Sensitivity of the IC test at 24 months 2. Specificity of the IC test at 24 months 3. Negative predictive value of the IC test at 24 months
Assess serial performance of serial testing with the AAC and IC tests.
Time frame: 24 months
Assess the performance of the of serial testing with the AAC and IC tests
2 secondary outcomes
Assess ATT Test Accuracy
Time frame: Up to 24 months
Determine Health Outcomes
Time frame: Up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2025.
- Sponsor websiteLink provided by the sponsor.
- 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.
James Jett, MD principal investigator
Biodesix, Inc.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Nodules, run by Biodesix, Inc. at 5 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 3 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: under way, not looking for participants, as of the sponsor's last update on 7 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
This study is still under way. Results are not available in the source record yet.
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?
Assess Test Performance of AAT test (time frame: Up to 24 months). The study lists 3 primary outcomes in all. 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 7 Feb 2025.