Identification of a Plasma Proteomic Signature for Lung Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Precancerous Conditions
- Sponsor
- Integrated Diagnostics
- Enrollment
- 475
- Locations
- 12
- Primary Endpoint
- Incidence rate of Non-Small Cell Lung Cancer
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Outcomes
Primary Outcomes
Incidence rate of Non-Small Cell Lung Cancer
Time Frame: 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 Outcomes
- Panel of proteins(At the end of the study)