Genetic Susceptibility to Lung Cancer in Never Smokers

Lung Cancer Clinical Trial

Official title:

Genetic Susceptibility to Lung Cancer in Never Smokers

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00597636
• Other study ID #: 05-038
• Status: Active, not recruiting
• Start date: June 2005
• Est. completion date: June 2025

Study information

• Verified date: June 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 238
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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).

Related Conditions & MeSH terms

• Genetic Predisposition to Disease
• Lung Cancer
• Lung Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Memorial Sloan-Kettering Cancer Center	New York	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 evaluate germline genetic variants and their association with lung cancer in never smokers.		conclusion of study
Secondary	To evaluate whether overall DNA damage/repair capacity is associated with lung cancer in never smokers.		conclusion of study

External Links

•   Memorial Sloan-Kettering Cancer Center