Biomarkers for Diagnosis of Lung Nodules

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Lung Abscess Abscess Infections Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections Suppuration

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

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 -

Treatment and study plan

Primary outcomes

Evaluation of biomarkers in blood, sputum or urine.

Time frame: Baseline, 3-6 months, 12 months, 24 months, time of biopsy or surgery (if applicable), and 6 months post surgery (if applicable).

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.

Secondary outcomes

Evaluation of biomarkers after successful surgical treatment of malignant lung nodules.

Time frame: Within 3 years

The secondary hypothesis is that these biomarkers will decrease in concentration to the normal range after successful surgical treatment of malignant lung nodules.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Acronym: Nodule

Important dates

Study start: 2010
Primary completion: 2026
Study completion: 2027
First posted: Mar 12, 2010
Registry last updated: Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Recruiting