Survey and Blood Sample Collection for Patients With Lung Cancer Who Never Smoked Cigarettes

Lung Cancer Clinical Trial

Official title:

Survey and Blood Sample Collection for Patients With Lung Cancer Who Never Smoked Cigarettes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00745160
• Other study ID #: 08-104
• Status: Completed
• Phase: N/A
• First received: September 2, 2008
• Last updated: March 29, 2011
• Start date: August 2008
• Est. completion date: August 2010

Study information

• Verified date: March 2011
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to determine if collecting information and blood from a group of people who never smoked but who have lung cancer, is possible across the US. The investigators will collect information on each patient's diagnosis and treatments. If the collection is successful, blood samples will be used to try to identify new genes (which are the basic elements of heredity, passed from parents to their offspring), which may explain and predict why certain patients develop lung cancer without having smoked tobacco.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years or older

• histologically and/or cytologically proven diagnosis of non-small cell lung cancer

• never smoker, defined as having smoked less than 100 cigarettes over one's life-time

• completed survey and inclusion form

• signed informed consent

Exclusion Criteria:

• previous history of cancer (other than lung cancer)

• living outside the United States

• patients who cannot read English (as website and questionnaires will only be written in English)

• unable to understand the protocol or to give informed consent

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Other:
• blood sample and questionnaire
After giving informed consent, all patients will be asked to complete questionnaire and will be asked to provide a blood sample for DNA analysis. The questionnaire will consist of a detailed smoking questionnaire, based on the most recent Centers for Disease Control and Prevention (CDC) Behavioral Risk Factor Surveillance System Survey Questionnaire.

Locations

Country	Name	City	State
United States	Memoral Sloan Kettering Cancer Center	Basking Ridge	New Jersey
United States	Memorial Sloan-Kettering Cancer Center @ Suffolk	Commack	New York
United States	Memorial Sloan-Kettering Cancer Center	New York	New York
United States	Memorial Sloan-Kettering Cancer Center at Mercy Medical Center	Rockville Centre	New York
United States	Memoral Sloan Kettering Cancer Center@Phelps	Sleepy Hollow	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the feasibility of an internet-based protocol to collect clinical information and biological specimens from 2,000 never smokers with lung cancer.		conclusion of the study	No

External Links

•   Memorial Sloan-Kettering Cancer Center