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Clinical Trials/NCT00611598
NCT00611598
Completed
Not Applicable

DNA Repair and Genetic Susceptibility to Lung Cancer

Memorial Sloan Kettering Cancer Center1 site in 1 country218 target enrollmentFebruary 11, 2003

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Lung Cancer
Sponsor
Memorial Sloan Kettering Cancer Center
Enrollment
218
Locations
1
Primary Endpoint
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.
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 11, 2003
End Date
March 24, 2023
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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

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.

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • To determine the association between cellular DNA repair and genetic alterations in DNA repair and associated pathways.(conclusion of the study)

Study Sites (1)

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