Survey and Blood Sample Collection for Patients With Lung Cancer Who Never Smoked Cigarettes - Full Text View

Purpose

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.

Condition	Intervention
Lung Cancer	Other: blood sample and questionnaire

MedlinePlus related topics:

Cancer Lung Cancer

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective

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

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:

To assess the feasibility of an internet-based protocol to collect clinical information and biological specimens from 2,000 never smokers with lung cancer. [ Time Frame: conclusion of the study ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples With DNA

Biospecimen Description:

blood sample for DNA analysis

Estimated Enrollment:	2000
Study Start Date:	August 2008
Estimated Study Completion Date:	August 2010
Estimated Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1 Never-smokers with lung cancer	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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Never-smokers with lung cancer

Internet recruitment The study will be advertised through a specifically designed website linked to the MSKCC Lung Cancer webpage. The website will be designed after approval of the study. The website will be accordingly reviewed by the IRB. We plan to advertise this study by word-of mouth at scientific meetings and on patient associations' websites and/or bulletins, with permission. The website will post a description of the study and an invitation to participate.

Interested patients will be given an email or mail address and/or phone number to contact MSKCC investigators about the study.

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00745160

Contacts


Contact: William Pao, MD, PhD		paow@mskcc.org

Contact: Gregory Riley, MD, PhD		rielyg@mskcc.org

Locations


United States, New Jersey
	Memoral Sloan Kettering Cancer Center	Recruiting
	Basking Ridge, New Jersey, United States
	Contact: William Pao, MD, PhD paow@mskcc.org

United States, New York
	Memorial Sloan-Kettering Cancer Center	Recruiting
	New York, New York, United States, 10065
	Contact: William Pao, MD, PhD paow@mskcc.org
	Contact: Gregory Riely, MD, PhD rielyg@mskcc.org
	Principal Investigator: William Pao, PhD
	Memoral Sloan Kettering Cancer Center@Phelps	Recruiting
	Sleepy Hollow, New York, United States
	Contact: William Pao, MD, PhD paow@mskcc.org
	Memorial Sloan-Kettering Cancer Center	Recruiting
	New York, New York, United States, 10065
	Contact: William Pao, MD, PhD 866-854-4652 neversmokerswithlungcancer@mskcc.org
	Memorial Sloan-Kettering Cancer Center at Mercy Medical Center	Recruiting
	Rockville Centre, New York, United States, 11570
	Contact: William Pao, MD, PhD paow@mskcc.org
	Memorial Sloan-Kettering Cancer Center @ Suffolk	Recruiting
	Commack, New York, United States, 11725
	Contact: William Pao, MD, PhD paow@mskcc.org

Sponsors and Collaborators

Memorial Sloan-Kettering Cancer Center

Investigators


Principal Investigator:	William Pao, MD, PhD	Memorial Sloan-Kettering Cancer Center

More Information

Memorial Sloan-Kettering Cancer Center This link exits the ClinicalTrials.gov site

Description of protocol on Memorial Sloan-Kettering web site This link exits the ClinicalTrials.gov site

Responsible Party:	Memorial Sloan-Kettering Cancer Center ( William Pao, MD )
Study ID Numbers:	08-104
First Received:	September 2, 2008
Last Updated:	October 23, 2008
ClinicalTrials.gov Identifier:	NCT00745160
Health Authority:	United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:

Questionaires

Study placed in the following topic categories:

Thoracic Neoplasms

Respiratory Tract Diseases

Lung Neoplasms

Lung Diseases

Additional relevant MeSH terms:

Respiratory Tract Neoplasms

Neoplasms

Neoplasms by Site

ClinicalTrials.gov processed this record on October 24, 2008

Sponsored by:	Memorial Sloan-Kettering Cancer Center
Information provided by:	Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:	NCT00745160