Clinical trial NCT00597636: Genetic Susceptibility to Lung Cancer in Never Smokers
Official title: Genetic Susceptibility to Lung Cancer in Never Smokers
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Lung Cancer
Keywords: smokers
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2008-01-18
Enrollment: 238
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: MSKCC clinics

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.


Eligibility criteria: 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).

Primary outcomes:
measure: To evaluate germline genetic variants and their association with lung cancer in never smokers.
timeFrame: conclusion of study
Secondary outcomes:
measure: To evaluate whether overall DNA damage/repair capacity is associated with lung cancer in never smokers.
timeFrame: conclusion of study
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Irene Orlow, PhD
role: PRINCIPAL_INVESTIGATOR
References: