Genetic Susceptibility to Lung Cancer in Never Smokers
This study is ongoing, but not recruiting participants.
Sponsor:
Memorial Sloan-Kettering Cancer Center
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, 2013
Last verified: January 2013
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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 2013 |
| Estimated Primary Completion Date: | June 2013 (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
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, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Memorial Sloan-Kettering Cancer Center:
|
smokers |
Additional relevant MeSH terms:
|
Disease Susceptibility Genetic Predisposition to Disease Lung Neoplasms Disease Attributes Pathologic Processes Respiratory Tract Neoplasms |
Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 21, 2013