LungLB in Subjects Presenting With Indeterminate Pulmonar... | NCT05171491

Studies
LungLB in Subjects Presenting With Indeterminate Pulmonary Nodules

NCT05171491

Sponsor

LungLife AI

Status

Unknown status

Last Update Posted

Jun 13, 2024Actual

Enrollment

425Actual

Phase

Not provided

Conditions

Solitary Pulmonary Nodule
Multiple Pulmonary Nodules

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 26, 2022Actual

Primary Completion Date

Dec 30, 2023Actual

Completion Date

Sep 2, 2024Estimated

First Submitted Date

Nov 12, 2021

First Submission Date that Met QC Criteria

Dec 10, 2021

First Posted Date

Dec 29, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 11, 2024

Last Update Posted Date

Jun 13, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

425Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Indeterminate Lung Nodule		Subjects that present with indeterminate lung nodules at time of biopsy. No intervention outside of standard of care.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Sensitivity and specificity of LungLB test as compared to results from a tissue/FNA biopsy.		up to 60 days

Secondary Outcomes

Measure	Description	Time Frame
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.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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:
1. is solid ≤3 cm; or
2. is nonsolid, ground glass opacity, of any size; or
3. is part solid, where the solid component is no larger than 3cm (maximum diameter).

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

Not provided

Standard Ages

AdultOlder 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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michael Donovan, MD	LungLife AI	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clinical Site 04		Los Angeles	California	90095	United States
Clinical Site 05

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003074	Solitary Pulmonary Nodule
D055613	Multiple Pulmonary Nodules
D008175	Lung Neoplasms

Ancestor Terms

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided