Identification of a Plasma Proteomic Signature for Lung Cancer

Completed

• Conditions: Precancerous Conditions; Carcinoma

• Registration Number: NCT01752101
• Lead Sponsor: Integrated Diagnostics

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.

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-11-30
• Study First Submitted QC: 2012-12-17
• Study First Posted: 2012-12-19
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-07
• Last Update Posted: 2015-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 475

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence rate of Non-Small Cell Lung Cancer	24 months after enrollment	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.

Secondary Outcome Measures

Name	Time	Method
Panel of proteins	At the end of the study	The positive and negative predictive value of the test to differentiate between malignancy and inflammatory diseases such as granulomatous disorders.

Trial Locations

Locations (12)

Kaiser Permanente Northern California; 🇺🇸 San Francisco, California, United States

Lahey Hospital & Medical Center; 🇺🇸 Burlington, Massachusetts, United States

Cardiopulmonary Research Science and Technology Institute; 🇺🇸 Dallas, Texas, United States

Intermountain Healthcare; 🇺🇸 Murray, Utah, United States

University of Miami - Sylvester Comprehensive Cancer Center; 🇺🇸 Miami, Florida, United States

Geisinger Medical Center; 🇺🇸 Danville, Pennsylvania, United States

Group Health Research Institute; 🇺🇸 Seattle, Washington, United States

North East Alabama Regional Medical Center; 🇺🇸 Anniston, Georgia, United States

Greater Baltimore Medical Center; 🇺🇸 Baltimore, Maryland, United States

Henry Ford Hospital; 🇺🇸 Detroit, Michigan, United States

University of Cincinnati; 🇺🇸 Cincinnati, Ohio, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States