Genetic Susceptibility to Lung Cancer in Never Smokers

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborator:

University of New Mexico

Information provided by (Responsible Party):

Memorial Sloan-Kettering Cancer Center

ClinicalTrials.gov Identifier:

NCT00597636

First received: January 10, 2008

Last updated: January 7, 2013

Last verified: January 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

January 10, 2008

Last Updated Date

January 7, 2013

Start Date ^ICMJE

June 2005

Estimated Primary Completion Date

June 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

To evaluate germline genetic variants and their association with lung cancer in never smokers. [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00597636 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To evaluate whether overall DNA damage/repair capacity is associated with lung cancer in never smokers. [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Genetic Susceptibility to Lung Cancer in Never Smokers

Official Title ^ICMJE

Genetic Susceptibility to Lung Cancer in Never Smokers

Brief Summary

The purpose of this study is to help us better understand the cellular changes that may lead to the development of lung cancer. We want to compare people who have never smoked and yet have been diagnosed with lung cancer to never smokers who have not developed lung cancer. We hope to use the information obtained in this study as the basis for future studies and will not regard the results from this study as final.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case Control
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Retention: Samples With DNA

Description:

Blood

Sampling Method

Non-Probability Sample

Study Population

MSKCC clinics

Condition ^ICMJE

Lung Cancer

Intervention ^ICMJE

Behavioral: Questionaire, blood sample
Provide 30ml blood for laboratory assays Complete Health Questionnaire
Behavioral: Questionaire, Blood sample
Provide 30ml blood for laboratory assays Complete Health Questionnaire

Study Group/Cohort (s)

1
NEVER SMOKERS WITH LUNG CANCER

Intervention: Behavioral: Questionaire, blood sample
2
NEVER SMOKERS WITHOUT ANY CANCER

Intervention: Behavioral: Questionaire, Blood sample

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

238

Estimated Completion Date

June 2013

Estimated Primary Completion Date

June 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Cases will be eligible for inclusion if:
They have been diagnosed with a lung cancer or have had previous surgical treatment for their lung cancer and have smoked fewer than 100 cigarettes in their lifetime, are/were not regular cigar or pipe smokers, and
They have had no prior chemotherapy or radiation treatment within the last year (Exception: genotyping analysis/screening can be performed on specimens from individuals who had chemo/radiation treatment within the last year as germline DNA will not be affected)
They speak and read English
They understand and agree to sign informed consent, and
They agree to give us a blood sample, and
They agree to complete the study questionnaire, and
They agree to have their pathology information reviewed by study personnel.
Controls will be eligible for inclusion if:
They have not been diagnosed with any type of cancer, exclusive of nonmelanoma skin cancer and have smoked fewer than 100 cigarettes in their lifetime, are/were not regular cigar or pipe smokers, and
They speak and read English
They understand and agree to sign informed consent, and
They agree to give us a blood sample, and
They agree to complete the study questionnaire.

Exclusion Criteria:

Subjects who do not meet the inclusion criteria for either the case or control groups will not be eligible for this study.
All individuals who otherwise meet the eligibility requirements above, but who have had chemotherapy or radiation therapy within 1 year of evaluation will be excluded (Exception: genotyping analysis/screening can be performed on specimens from individuals who had chemo/radiation treatment within the last year as germline DNA will not be affected).

Gender

Both

Ages

Not Provided

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00597636

Other Study ID Numbers ^ICMJE

05-038

Has Data Monitoring Committee

Not Provided

Responsible Party

Memorial Sloan-Kettering Cancer Center

Study Sponsor ^ICMJE

Memorial Sloan-Kettering Cancer Center

Collaborators ^ICMJE

University of New Mexico

Investigators ^ICMJE

Principal Investigator:

Irene Orlow, PhD

Memorial Sloan-Kettering Cancer Center

Information Provided By

Memorial Sloan-Kettering Cancer Center

Verification Date

January 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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