NCT01085864

Active Not Recruiting

Biomarkers for Diagnosis of Lung Nodules

University of Colorado, Denver Source

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Other study identifiers

Sponsor study identifier

09-1106.cc

Study Type

observational

Estimated enrollment

550

Locations

1 country

Sites

1

Timeline

Study Start

March 17, 2010

Actual (reported)

Primary Completion

November 1, 2026

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Study Completion

October 1, 2027

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: active not recruiting
Estimated enrollment: 550 participants
Study completion date: October 1, 2027
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
March 10, 2010
Actual (reported)
First Posted
March 12, 2010
Actual (reported)
Study Start
March 17, 2010
Actual (reported)
Primary Completion
November 1, 2026
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
October 1, 2027
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.

Last Updated: April 9, 2026
Status Verified: April 2026
Last Update Submitted: April 3, 2026

Conditions

Lung Abscess

Keywords

Lung NodulesA need exists for non-invasive testing to aid in clinical decision-making for CT scan detected lung nodules of indeterminate etiology.

Outcome Measures

Primary Outcomes (1)

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 (1)

Evaluation of biomarkers after successful surgical treatment of malignant lung nodules.
Within 3 years

Study Arms (1)

Patients with lung nodules on CT scan.

Eligibility Criteria

Age18 Years - 85 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodProbability Sample

Study Population

Patients being evaluated by CT Scan with Lung Nocules

You may qualify if:

Adult 18-85 years of age

Sponsors & Collaborators

University of Colorado, Denver
Otherlead

Study Sites (1)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Biospecimen

Retention: SAMPLES WITH DNA

Blood specimen, a sputum sample, a urine sample, and an exhaled breath sample.

MeSH Terms

Conditions

Lung Abscess

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsAbscessSuppurationLung DiseasesRespiratory Tract Diseases

Study Officials

York E Miller, M.D.
University of Colorado, Denver
PRINCIPAL INVESTIGATOR

Study Design

Study Type: observational
Observational Model: OTHER
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

March 10, 2010

First Posted

March 12, 2010

Study Start

March 17, 2010

Actual (reported)

Primary Completion

November 1, 2026

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

NCT06657898

Complicated Pneumonia (CP) in Children in South-East Europe

Recruiting

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.

You may not qualify if:

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 -

Contact the study team to confirm eligibility.

Study Completion

October 1, 2027

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Last Updated

April 9, 2026

Record last verified: 2026-04

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT01085864
Data provider: ClinicalTrials.gov
Source updated: 2026-04-09
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:22:26 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

Patients with lung nodules on CT scan.

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Biospecimen

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations