NCT01785342

Brief Summary

The goal is to improve the efficiency of the diagnostic follow-up of patients with indeterminate pulmonary nodules by determining whether biomarkers for lung cancer diagnosis that are measured in minimally invasive biospecimens are able to distinguish malignant from benign pulmonary nodules that are incidentally detected in high-risk smokers.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
489

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2013

Longer than P75 for all trials

Geographic Reach
1 country

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 5, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 7, 2013

Completed
9.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2022

Completed
Last Updated

March 15, 2022

Status Verified

February 1, 2022

Enrollment Period

9.2 years

First QC Date

February 5, 2013

Last Update Submit

February 28, 2022

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • Lung Cancer

    Subjects will be identified as Lung Cancer or no Lung Cancer (through diagnosis) within the 2 year followup period.

    2 years

Study Arms (1)

Indeterminate Pulmonary Nodule

The goal will be accomplished by recruiting 500 smokers with indeterminate pulmonary nodules (0.7cm - 3.0cm) on chest CT who will undergo fiberoptic bronchoscopy and will be followed for 2 years until a final diagnosis is made. Biosample and imaging collection will be done.

Other: Biosample and Imaging Collection

Interventions

Biosample and Imaging CollectionOTHER

Collection of listed biosamples and CT imaging.

Also known as: Blood,, Urine,, Buccal Scraping,, Nasal,, Bronchial Brushing,, Bronchial Biopsy,, Lung Tissue,, Sputum,, CT Imaging of Chest
Indeterminate Pulmonary Nodule

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Military personnel

You may qualify if:

  • years of age or older;
  • Initial diagnosis of indeterminate pulmonary nodule (0.7-3.0 cm);
  • Smoking status: Current or former smoker with ≥ 20 pack years (pack years = number of packs per day X number of years smoked)
  • Willing to undergo fiberoptic bronchoscopy;
  • Able to tolerate all biospecimen collection as required by protocol;
  • Able to comply with standard of care follow up visits including clinical exams, diagnostic work-ups, and imaging for a minimum of two years;
  • Able to fill out Patient Lung History questionnaire;
  • Willing and able to provide a written informed consent.

You may not qualify if:

  • History or previous diagnosis of lung cancer;
  • Diagnosis of pure ground glass opacities on chest CT;
  • Contraindications to nasal brushing or fiberoptic bronchoscopy including ulcerative nasal disease, hemodynamic instability, severe obstructive airway disease, unstable cardiac or pulmonary disease; inability to protect airway or altered level of consciousness;
  • Allergies to any local anesthetic that may be used to obtain biosamples in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Regents of the University of California LA (Los Angeles VA Healthcare System)

Los Angeles, California, 90073, United States

Location

University of California Los Angeles Medical Center

Los Angeles, California, 90095, United States

Location

Naval Medical Center San Diego

San Diego, California, 23708, United States

Location

Denver Research Institute

Denver, Colorado, 80220, United States

Location

Walter Reed National Military Medical Center

Bethesda, Maryland, 20814, United States

Location

Boston University Medical Center

Boston, Massachusetts, 02118, United States

Location

Boston VA Research Institute, Inc

Boston, Massachusetts, 02132, United States

Location

Health Research Inc. Roswell Park Division

Buffalo, New York, 14263, United States

Location

Trustees of University of Pennsylvania (Philadelphia VA Medical Center)

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Veterans Research Foundation of Pittsburgh

Pittsburgh, Pennsylvania, 15240, United States

Location

Middle Tennessee Research Institute (Vanderbilt University)

Nashville, Tennessee, 37212, United States

Location

Dallas VA Research Corporation

Dallas, Texas, 75216, United States

Location

San Antonio Military Medical Center

San Antonio, Texas, 78219, United States

Location

Naval Medical Center Portsmouth

Portsmouth, Virginia, 23708, United States

Location

Related Publications (3)

  • Kinsey CM, Billatos E, Mori V, Tonelli B, Cole BF, Duan F, Marques H, de la Bruere I, Onieva J, San Jose Estepar R, Cleveland A, Idelkope D, Stevenson C, Bates JHT, Aberle D, Spira A, Washko G, San Jose Estepar R. A simple assessment of lung nodule location for reduction in unnecessary invasive procedures. J Thorac Dis. 2021 Jul;13(7):4207-4216. doi: 10.21037/jtd-20-3093.

    PMID: 34422349DERIVED

  • Billatos E, Ash SY, Duan F, Xu K, Romanoff J, Marques H, Moses E, Han MK, Regan EA, Bowler RP, Mason SE, Doyle TJ, San Jose Estepar R, Rosas IO, Ross JC, Xiao X, Liu H, Liu G, Sukumar G, Wilkerson M, Dalgard C, Stevenson C, Whitney D, Aberle D, Spira A, San Jose Estepar R, Lenburg ME, Washko GR; DECAMP and COPDGene Investigators. Distinguishing Smoking-Related Lung Disease Phenotypes Via Imaging and Molecular Features. Chest. 2021 Feb;159(2):549-563. doi: 10.1016/j.chest.2020.08.2115. Epub 2020 Sep 16.

    PMID: 32946850DERIVED

  • Billatos E, Duan F, Moses E, Marques H, Mahon I, Dymond L, Apgar C, Aberle D, Washko G, Spira A; DECAMP investigators. Detection of early lung cancer among military personnel (DECAMP) consortium: study protocols. BMC Pulm Med. 2019 Mar 7;19(1):59. doi: 10.1186/s12890-019-0825-7.

    PMID: 30845938DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood, Urine, Sputum, Nasal brushing, Buccal scraping, Bronchial Biopsy, Bronchial brushing, lung tissue

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Blood Specimen CollectionUrination

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative TechniquesUrinary Tract Physiological PhenomenaReproductive and Urinary Physiological Phenomena

Study Officials

  • Ehab Billatos, MD

    Boston University

    PRINCIPAL INVESTIGATOR

  • Deni Aberle, MD

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 5, 2013

First Posted

February 7, 2013

Study Start

January 1, 2013

Primary Completion

February 28, 2022

Study Completion

February 28, 2022

Last Updated

March 15, 2022

Record last verified: 2022-02

Locations

US(15)