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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01752101
Other study ID # 1013-12
Secondary ID
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


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
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