- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00611598
DNA Repair and Genetic Susceptibility to Lung Cancer
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 with a second primary lung cancer with those who have only a first primary 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.
We will analyze your blood cells and DNA to measure the changes in several genes that we believe may be involved in lung cancer. We also want to evaluate the capacity for your DNA to repair itself.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Cases will be eligible for inclusion if:
- They have been diagnosed with a second primary lung cancer, and
- They speak English or a language for which we have a translated consent form, and
- They understand and agree to sign informed consent, and
- They agree to give us a blood sample, and
- They agree to give us a tissue sample when part of normal clinical procedures, and
- They agree to complete the study questionnaires, and
- They agree to have their pathology information reviewed. This could include biopsy specimens.
Controls will be eligible for inclusion if
- They have been diagnosed with a first primary lung cancer, and
- They speak English or a language for which we have a translated consent form, and
- They understand and agree to sign informed consent, and
- They agree to give us a blood sample, and
- They agree to give us a tissue sample when part of normal clinical procedures, and
- They agree to complete the study questionnaires,
- They agree to have their pathology information reviewed. This will could include biopsy specimens.
Exclusion Criteria:
- Subjects who do not meet the inclusion criteria as either cases or controls will not be eligible for this study.
- Control subjects who have a history of another cancer, other than nonmelanoma skin cancer or a first primary lung cancer, will not be eligible for this study.
- Control subjects who otherwise meet the eligibility requirements above but who have had chemotherapy and/or are currently being treated with chemotherapy will be excluded from the functional assay, but not from the genotyping.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
1
second primary lung cancer
|
Pt will have three green top tubes of blood drawn.
The questionnaire will be filled out by the study subject.
This may be completed at home and mailed in a provided stamped addressed envelope if the patient prefer, or obtained by phone interview with a research assistant.
|
2
single primary lung cancer
|
Pt will have three green top tubes of blood drawn.
The questionnaire will be filled out by the study subject.
This may be completed at home and mailed in a provided stamped addressed envelope if the patient prefer, or obtained by phone interview with a research assistant.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To conduct a pilot study of the role of DNA repair in lung cancer subjects with high genetic risk - those with a second primary lung cancer - compared to subjects with only one lung cancer.
Time Frame: conclusion of the study
|
conclusion of the study
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To determine the association between cellular DNA repair and genetic alterations in DNA repair and associated pathways.
Time Frame: conclusion of the study
|
conclusion of the study
|
Collaborators and Investigators
Investigators
- Principal Investigator: Irene Orlow, PhD, Memorial Sloan Kettering Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 03-003
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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