Overview

This trial is active, not recruiting.

Condition lung cancer
Treatments questionaire, blood sample
Sponsor Memorial Sloan Kettering Cancer Center
Collaborator University of New Mexico
Start date June 2005
End date June 2017
Trial size 238 participants
Trial identifier NCT00597636, 05-038

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
Arm
NEVER SMOKERS WITH LUNG CANCER
questionaire, blood sample
Provide 30ml blood for laboratory assays Complete Health Questionnaire
NEVER SMOKERS WITHOUT ANY CANCER
questionaire, blood sample
Provide 30ml blood for laboratory assays Complete Health Questionnaire

Primary Outcomes

Measure
To evaluate germline genetic variants and their association with lung cancer in never smokers.
time frame: conclusion of study

Secondary Outcomes

Measure
To evaluate whether overall DNA damage/repair capacity is associated with lung cancer in never smokers.
time frame: conclusion of study

Eligibility Criteria

Male or female participants of any age.

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).

Additional Information

Official title Genetic Susceptibility to Lung Cancer in Never Smokers
Principal investigator Irene Orlow, PhD
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center.