Overview

This trial is active, not recruiting.

Conditions lung cancer, single primary lung cancer, second primary lung cancer
Treatments blood draw and questionnaires
Sponsor Memorial Sloan Kettering Cancer Center
Collaborator University of New Mexico
Start date February 2003
End date September 2016
Trial size 218 participants
Trial identifier NCT00611598, 03-003

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
second primary lung cancer
blood draw and questionnaires
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.
single primary lung cancer
blood draw and questionnaires
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.

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.
time frame: conclusion of the study

Secondary Outcomes

Measure
To determine the association between cellular DNA repair and genetic alterations in DNA repair and associated pathways.
time frame: conclusion of the study

Eligibility Criteria

Male or female participants of any age.

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.

Additional Information

Official title DNA Repair and Genetic Susceptibility to Lung Cancer
Principal investigator Irene Orlow, PhD
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center.