Biomarkers for Diagnosis of Lung Nodules | NCT01085864

Studies
Biomarkers for Diagnosis of Lung Nodules

NCT01085864

Sponsor

University of Colorado, Denver

Status

Active, not recruiting

Last Update Posted

Apr 9, 2026Actual

Enrollment

550Estimated

Phase

Not provided

Conditions

Lung Abscess

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

Apr 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 17, 2010Actual

Primary Completion Date

Nov 1, 2026Estimated

Completion Date

Oct 1, 2027Estimated

First Submitted Date

Mar 10, 2010

First Submission Date that Met QC Criteria

Mar 11, 2010

First Posted Date

Mar 12, 2010Estimated

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

Apr 3, 2026

Last Update Posted Date

Apr 9, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

A need exists for non-invasive testing to aid in clinical decision-making for Computerized Tomography (CT) scan detected lung nodules of indeterminate etiology. The investigators hypothesize that biomarkers detectable in blood, sputum or urine may be useful for guiding clinical decisions in the setting of CT detected lung nodules to determine which nodules are malignant and which are benign. The investigators also hypothesize that these biomarkers will decrease in concentration to the normal range after successful surgical treatment of malignant lung nodules.

Detailed Description

The Biomarkers for Diagnosis of Lung Nodules Study is a prospective study of a cohort of 500 individuals with lung nodules of indeterminate etiology that are identified by CT scans. Either biopsy or repeat CT scans must be clinically indicated to determine the etiology of the nodule. Patients will be asked to allow investigators access to CT scan images and spirometry data, and provide blood, sputum, urine, and exhaled breath samples over the course of the study. Patients will also be asked to allow investigators to access pathology records if a biopsy or surgical excision of the nodule is clinically indicated.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

550Estimated

Label	Type	Description	Intervention Names
Patients with lung nodules on CT scan.		Patients with lung nodules on CT scan.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evaluation of biomarkers in blood, sputum or urine.	The primary hypothesis is that biomarkers detectable in blood, sputum, or urine will be useful for guiding clinical decisions in the setting of CT detected lung nodules.	Baseline, 3-6 months, 12 months, 24 months, time of biopsy or surgery (if applicable), and 6 months post surgery (if applicable).

Secondary Outcomes

Measure	Description	Time Frame
Evaluation of biomarkers after successful surgical treatment of malignant lung nodules.	The secondary hypothesis is that these biomarkers will decrease in concentration to the normal range after successful surgical treatment of malignant lung nodules.	Within 3 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult 18-85 years of age
Patients referred to pulmonologists, oncologists, or thoracic surgeons for the evaluation of peripheral lung nodules found on CT scan.
Repeat CT scans, biopsy or surgical excision are clinically indicated to determine the etiology of the nodule.
One or more lung nodules must be between 8 mm and 30 mm in the greatest diameter.
Patients must be fully informed of the investigational nature of the procedure and sign an informed consent.

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Exclusion Criteria:

Lung nodules or masses greater than 30 mm in the greatest dimension.
Lung nodules that have solid calcification.
Lung nodules or masses with CT evidence of partial or complete obstruction of a lobar bronchus, main stem bronchus or the trachea.
No prior cancer with the exception of non-melanoma skin cancer.
Life expectancy of < 6 months
Any individual who does not give oral and written consent for participation -

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Patients being evaluated by CT Scan with Lung Nocules

Sampling Method

Probability Sample

ID	Term
D012141	Respiratory Tract Infections
D007239	Infections
D000038	Abscess
D013492	Suppuration