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, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Lung Cancer
Behavioral: Questionaire, blood sample
Behavioral: Questionaire, Blood sample

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Genetic Susceptibility to Lung Cancer in Never Smokers

Resource links provided by NLM:


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

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

Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples With DNA

Blood


Enrollment: 238
Study Start Date: June 2005
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
NEVER SMOKERS WITH LUNG CANCER
Behavioral: Questionaire, blood sample
Provide 30ml blood for laboratory assays Complete Health Questionnaire
2
NEVER SMOKERS WITHOUT ANY CANCER
Behavioral: Questionaire, Blood sample
Provide 30ml blood for laboratory assays Complete Health Questionnaire

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

MSKCC clinics

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00597636

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
University of New Mexico
Investigators
Principal Investigator: Irene Orlow, PhD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00597636     History of Changes
Other Study ID Numbers: 05-038
Study First Received: January 10, 2008
Last Updated: January 7, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
smokers

Additional relevant MeSH terms:
Disease Susceptibility
Lung Neoplasms
Genetic Predisposition to Disease
Disease Attributes
Pathologic Processes
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 22, 2014