Identification of a Plasma Proteomic Signature for Lung Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

475 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-10-31

Study Completion Date

2014-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Precancerous Conditions Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes