Clinical trial NCT00611598: DNA Repair and Genetic Susceptibility to Lung Cancer
Official title: DNA Repair and Genetic Susceptibility to Lung Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Single Primary Lung Cancer
Second Primary Lung Cancer
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2008-02-11
Enrollment: 218
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: MSKCC Clinic

Brief 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 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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: conclusion of the study
Secondary outcomes:
measure: To determine the association between cellular DNA repair and genetic alterations in DNA repair and associated pathways.
timeFrame: conclusion of the study
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Irene Orlow, PhD
role: PRINCIPAL_INVESTIGATOR
References: