Identification of a Plasma Proteomic Signature for Lung Cancer

Integrated Diagnostics

Status: Completed

Conditions: Precancerous Conditions; Carcinoma

Study type: Observational

Funder types: Industry

Identifiers

NCT01752101

1013-12

Details and patient eligibility

About

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.

Full 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.

Enrollment: 475 patients

Sex: All

Ages: 40+ years old

Volunteers: Accepts Healthy Volunteers

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