Identification of a Plasma Proteomic Signature for Lung Cancer

Carcinoma Clinical Trial

Official title:

Identification of a Plasma Proteomic Signature for Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01752101
• Other study ID #: 1013-12
• Status: Completed
• Phase: N/A
• First received: November 30, 2012
• Last updated: January 7, 2015
• Start date: October 2012
• Est. completion date: December 2014

Study information

• Verified date: January 2015
• Source: Integrated Diagnostics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Quorum Review IRB
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma
• Precancerous Conditions

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Integrated Diagnostics

Country where clinical trial is conducted

United States, 

Outcome

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