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

January 10, 2008
January 7, 2014
June 2005
June 2014   (final data collection date for primary outcome measure)
To evaluate germline genetic variants and their association with lung cancer in never smokers. [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00597636 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Genetic Susceptibility to Lung Cancer in Never Smokers
Genetic Susceptibility to Lung Cancer in Never Smokers

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.

Not Provided
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Blood

Non-Probability Sample

MSKCC clinics

Lung Cancer
  • 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
  • 1
    NEVER SMOKERS WITH LUNG CANCER
    Intervention: Behavioral: Questionaire, blood sample
  • 2
    NEVER SMOKERS WITHOUT ANY CANCER
    Intervention: Behavioral: Questionaire, Blood sample
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
238
June 2014
June 2014   (final data collection date for primary outcome measure)

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).
Both
Not Provided
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00597636
05-038
Not Provided
Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
University of New Mexico
Principal Investigator: Irene Orlow, PhD Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
January 2014

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