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COMPLETEDNCT01752101

Identification of a Plasma Proteomic Signature for Lung Cancer

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 ap...

Lead sponsor: Integrated Diagnostics•12 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Integrated Diagnostics

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.

Age

40 - No limit years

Sex

ALL

Healthy Volunteers

Yes

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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: January 9, 2015Terms

Trial snapshot

StatusCOMPLETED

Phase—

Enrollment475

Start dateOct 2012

Last updatedJan 9, 2015

Condition

Precancerous Conditions Carcinoma

Locations shown

Kaiser Permanente Northern California

San Francisco, California

University of Miami - Sylvester Comprehensive Cancer Center

Miami, Florida

North East Alabama Regional Medical Center

Anniston, Georgia

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 9, 2015Data synced to Clareo: May 3, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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