Carcinoma Clinical Trial
Official title:
Identification of a Plasma Proteomic Signature for Lung Cancer
Verified date | January 2015 |
Source | Integrated Diagnostics |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Quorum Review IRB |
Study type | Observational |
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.
Status | Completed |
Enrollment | 475 |
Est. completion date | December 2014 |
Est. primary completion date | December 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 40 Years and older |
Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | North East Alabama Regional Medical Center | Anniston | Georgia |
United States | Greater Baltimore Medical Center | Baltimore | Maryland |
United States | Lahey Hospital & Medical Center | Burlington | Massachusetts |
United States | University of Cincinnati | Cincinnati | Ohio |
United States | Cardiopulmonary Research Science and Technology Institute | Dallas | Texas |
United States | Geisinger Medical Center | Danville | Pennsylvania |
United States | Henry Ford Hospital | Detroit | Michigan |
United States | University of Miami - Sylvester Comprehensive Cancer Center | Miami | Florida |
United States | Intermountain Healthcare | Murray | Utah |
United States | Mayo Clinic | Rochester | Minnesota |
United States | Kaiser Permanente Northern California | San Francisco | California |
United States | Group Health Research Institute | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
Integrated Diagnostics |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | Panel of proteins | The positive and negative predictive value of the test to differentiate between malignancy and inflammatory diseases such as granulomatous disorders. | At the end of the study | No |
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