Clinical trial NCT01752101: Identification of a Plasma Proteomic Signature for Lung Cancer
Official title: Identification of a Plasma Proteomic Signature for Lung Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Precancerous Conditions
Carcinoma
Keywords: Precancerous Conditions
Carcinoma
Lead sponsor: Integrated Diagnostics
Sponsor class: INDUSTRY
First posted: 2012-12-19
Enrollment: 475
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing procedure for histologic diagnosis of lung nodule(s)

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.

Detailed description: Blood samples are obtained from those patients undergoing procedures to determine if a lung nodule is benign or cancerous. The data from the study will not be used to guide or influence the treatment of the patients enrolled in this study. There is no change from the normal standard of care that patients receive.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Incidence rate of Non-Small Cell Lung Cancer
timeFrame: 24 months after enrollment
Secondary outcomes:
measure: Panel of proteins
timeFrame: At the end of the study
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Kaiser Permanente Northern California
state: California
city: Miami
country: United States
facility: University of Miami - Sylvester Comprehensive Cancer Center
state: Florida
city: Anniston
country: United States
facility: North East Alabama Regional Medical Center
state: Georgia
city: Baltimore
country: United States
facility: Greater Baltimore Medical Center
state: Maryland
city: Burlington
country: United States
facility: Lahey Hospital & Medical Center
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Danville
country: United States
facility: Geisinger Medical Center
state: Pennsylvania
city: Dallas
country: United States
facility: Cardiopulmonary Research Science and Technology Institute
state: Texas
city: Murray
country: United States
facility: Intermountain Healthcare
state: Utah
city: Seattle
country: United States
facility: Group Health Research Institute
state: Washington
Study officials:
affiliation: Integrated Diagnostics, Inc.
name: Russell F. Hudnall
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.