Validation of a Multi-gene Test for Lung Cancer Risk
This study is currently recruiting participants.
Verified March 2012 by University of Toledo Health Science Campus
Sponsor:
University of Toledo Health Science Campus
Collaborator:
Information provided by (Responsible Party):
James Willey, University of Toledo Health Science Campus
ClinicalTrials.gov Identifier:
NCT01130285
First received: May 24, 2010
Last updated: March 29, 2012
Last verified: March 2012
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Purpose
The purpose of this study is to determine the validity of a multi-gene Lung Cancer Risk Test (LCRT). In the process, the investigators will establish a bank of NBEC samples and corresponding blood samples from individuals demographically at increased risk for lung cancer.
| Condition | Intervention |
|---|---|
|
Lung Cancer |
Genetic: Lung Cancer Risk Test |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Validation of a Multi-gene Test for Lung Cancer Risk |
Resource links provided by NLM:
Further study details as provided by University of Toledo Health Science Campus:
| Estimated Enrollment: | 785 |
| Study Start Date: | May 2011 |
| Estimated Study Completion Date: | September 2015 |
| Estimated Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Non Lung Cancer Heavy Smoker
Subjects will be ≥ 50 years of age and have a ≥ 20 pack year smoking history and will be either healthy volunteers or individuals undergoing diagnostic bronchoscopy.
|
Genetic: Lung Cancer Risk Test
Measurement of gene expression in normal bronchial epithelial cells obtained at time of bronchoscopy.
Other Name: LCRT
|
Detailed Description:
Because more than 160,000 individuals die of lung cancer/year in the United States alone, it is important to use the best possible methods to determine whether increased surveillance of individuals at highest risk for lung cancer will result in reduced lung cancer mortality. The Lung Cancer Risk Test (LCRT) proposed for evaluation promises to accurately identify the 10-15% of the population that is most susceptible to lung cancer based on genetic predisposition. More than 90 million individuals in the United States alone are demographically at high risk for lung cancer and potential candidates for increased surveillance.
Eligibility| Ages Eligible for Study: | 50 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Study Population
The study population will consist of subjects aged 50 to 90 and with 20 or more pack year smoking history who have clinical need for diagnostic bronchoscopy (e.g. they may present with respiratory symptoms or abnormal test results consistent with the need for bronchoscopy) but are determined not to have lung cancer at the time of enrollment or within three months after the date of enrollment.
Criteria
Inclusion Criteria:
- 20 or more pack year smoking history
- clinical need for diagnostic bronchoscopy
Exclusion Criteria:
- Lung Cancer within 3 months after the date of enrollment
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01130285
Contacts
| Contact: James Willey, MD | 419.383.3543 | james.willey2@utoledo.edu |
Locations
| United States, Colorado | |
| National Jewish Health | Recruiting |
| Denver, Colorado, United States, 80206 | |
| Contact: Elizabeth Klopper 303-398-1414 kloppere@njhealth.org | |
| Principal Investigator: Ali Musani, MD | |
| United States, Michigan | |
| University of Michigan | Recruiting |
| Ann Arbor, Michigan, United States, 48109 | |
| Contact: Barbara Torretti 734-936-9875 btorret@med.umich.edu | |
| Principal Investigator: Doug Ardenberg, MD | |
| Henry Ford | Recruiting |
| Detroit, Michigan, United States, 48202 | |
| Contact: Deborah Emmer 313-874-6267 demmer1@hfhs.org | |
| Principal Investigator: Javier Diaz-Mendoza, MD | |
| Sub-Investigator: Albert Levin | |
| United States, Minnesota | |
| Mayo Clinic | Recruiting |
| Rochester, Minnesota, United States, 55905 | |
| Contact: Cindy Beinhorn 507-538-0595 beinhorn.cynthia@mayo.edu | |
| Principal Investigator: David Midthun, MD | |
| United States, Ohio | |
| Cleveland Clinic Foundation | Recruiting |
| Cleveland, Ohio, United States, 44195 | |
| Contact: Misty Edmisten 216-444-5023 edmistm@ccf.org | |
| Principal Investigator: Peter Mazzone, MD | |
| Ohio State University | Recruiting |
| Columbus, Ohio, United States, 43221 | |
| Contact: Anita Kapil 614-366-1388 Anita.kapil@osumc.edu | |
| Principal Investigator: Patrick Nana-Sinkam, MD | |
| University of Toledo, Health Science Campus | Recruiting |
| Toledo, Ohio, United States, 43614 | |
| Contact: Adele Griffin 419-383-6919 adele.griffin@utoledo.edu | |
| Principal Investigator: James Willey, MD | |
| The Toledo Hospital | Recruiting |
| Toledo, Ohio, United States, 43606 | |
| Contact: Lani Brighton 419-291-2373 lani.brighton@promedica.org | |
| Principal Investigator: Ron Wainz, MD | |
| Mercy St. Vincent Medical Center | Recruiting |
| Toledo, Ohio, United States, 43608 | |
| Contact: Dee Tilley 419-251-4919 dee_tilley@mhsnr.org | |
| Principal Investigator: James Tita, DO | |
| United States, South Carolina | |
| Medical University of South Carolina | Recruiting |
| Charleston, South Carolina, United States, 29425 | |
| Contact: Kalon Eways 843-792-3167 eways@musc.edu | |
| Principal Investigator: Gerald Silvestri, MD | |
| United States, Tennessee | |
| Vanderbilt | Recruiting |
| Nashville, Tennessee, United States, 37232 | |
| Contact: Willie Hudson 615-936-5804 willie.j.hudson@vanderbilt.edu | |
| Principal Investigator: Pierre Massion, MD | |
| Tennessee Valley Veterans Admin. | Recruiting |
| Nashville, Tennessee, United States, 37232 | |
| Contact: Willie Hudson 615-936-5804 willie.j.hudson@vanderbilt.edu | |
| Principal Investigator: Pierre Massion, MD | |
| United States, Virginia | |
| Inova Fairfax Hospital | Recruiting |
| Falls Church, Virginia, United States, 22042 | |
| Contact: Mary Smith 703-776-7128 marya.smith@inova.org | |
| Principal Investigator: Steven Nathan, MD | |
Sponsors and Collaborators
University of Toledo Health Science Campus
Investigators
| Principal Investigator: | James Willey, MD | University of Toledo Health Science Campus |
More Information
No publications provided
| Responsible Party: | James Willey, Principal Investigator, University of Toledo Health Science Campus |
| ClinicalTrials.gov Identifier: | NCT01130285 History of Changes |
| Other Study ID Numbers: | UTHSC - 11, 1RC2CA148572-01 |
| Study First Received: | May 24, 2010 |
| Last Updated: | March 29, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of Toledo Health Science Campus:
|
Lung Cancer |
Additional relevant MeSH terms:
|
Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site |
Neoplasms Lung Diseases Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on June 17, 2013