NCT01752101

Brief Summary

The primary objective is to identify a panel of plasma and/or serum proteins that differentiates the absence or presence of lung malignancy in samples obtained from subjects enrolled in this IRB/EC approved study with pulmonary nodules.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
475

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2012

Typical duration for all trials

Geographic Reach
1 country

12 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

October 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 30, 2012

Completed
19 days until next milestone

First Posted

Study publicly available on registry

December 19, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

January 9, 2015

Status Verified

January 1, 2015

Enrollment Period

2.2 years

First QC Date

November 30, 2012

Last Update Submit

January 7, 2015

Conditions

Precancerous ConditionsCarcinoma

Keywords

Precancerous ConditionsCarcinoma

Outcome Measures

Primary Outcomes (1)

  • Incidence rate of Non-Small Cell Lung Cancer

    The incidence rate of non-small cell lung cancer in the study population will be correlated to the predictive value of the Sponsor's blood test.

    24 months after enrollment

Secondary Outcomes (1)

  • Panel of proteins

    At the end of the study

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients undergoing procedure for histologic diagnosis of lung nodule(s)

You may qualify if:

  • age ≥ 40
  • any smoking status, e.g. current, former, or never
  • co-morbid conditions, e.g. COPD
  • Nodule size ≥ 4 mm and ≤ 30 mm (up to Stage 2B eligible), any spiculation or ground glass opacity
  • Pathology: malignant - adenocarcinoma, squamous, or large cell
  • Pathology: benign - inflammatory (e.g. granulomatous, infectious) or non-inflammatory (e.g. hamartoma)
  • Clinical stage, Primary tumor: ≤T2 (e.g. 1A, 1B, 2A and 2B)
  • Clinical stage, Regional lymph nodes: N0 or N1 only
  • Clinical stage, Distant metastasis: M0 only

You may not qualify if:

  • prior malignancy within 5 years of lung nodule diagnosis
  • No nodule size available
  • No pathology data available for those with
  • Current diagnosis of non-small cell lung cancer
  • Clinical stage: Primary tumor ≥T3; Regional lymph nodes: ≥N2; 4 Distant metastasis: ≥M1

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Kaiser Permanente Northern California

San Francisco, California, 94115, United States

Location

University of Miami - Sylvester Comprehensive Cancer Center

Miami, Florida, 33136, United States

Location

North East Alabama Regional Medical Center

Anniston, Georgia, 36207, United States

Location

Greater Baltimore Medical Center

Baltimore, Maryland, 21204, United States

Location

Lahey Hospital & Medical Center

Burlington, Massachusetts, 01805, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Mayo Clinic

Rochester, Minnesota, 55901, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

Geisinger Medical Center

Danville, Pennsylvania, 17822, United States

Location

Cardiopulmonary Research Science and Technology Institute

Dallas, Texas, 75230, United States

Location

Intermountain Healthcare

Murray, Utah, 84107, United States

Location

Group Health Research Institute

Seattle, Washington, 98101, United States

Location

Related Publications (2)

  • Kearney P, Hunsucker SW, Li XJ, Porter A, Springmeyer S, Mazzone P. An integrated risk predictor for pulmonary nodules. PLoS One. 2017 May 17;12(5):e0177635. doi: 10.1371/journal.pone.0177635. eCollection 2017.

    PMID: 28545097DERIVED

  • Vachani A, Hammoud Z, Springmeyer S, Cohen N, Nguyen D, Williamson C, Starnes S, Hunsucker S, Law S, Li XJ, Porter A, Kearney P. Clinical Utility of a Plasma Protein Classifier for Indeterminate Lung Nodules. Lung. 2015 Dec;193(6):1023-7. doi: 10.1007/s00408-015-9800-0. Epub 2015 Sep 16.

    PMID: 26376647DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples

MeSH Terms

Conditions

Precancerous ConditionsCarcinoma

Condition Hierarchy (Ancestors)

NeoplasmsNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Officials

  • Russell F. Hudnall

    Integrated Diagnostics, Inc.

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

November 30, 2012

First Posted

December 19, 2012

Study Start

October 1, 2012

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

January 9, 2015

Record last verified: 2015-01

Locations

US(12)