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.

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Key information

Conditions

Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Second Primary Lung Cancer Single Primary Lung Cancer Thoracic Neoplasms

Sex eligibility

All sexes

Study type

Observational

Primary location

Memorial Sloan Kettering Cancer Center

New York, 10065, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Blood draw and questionnaires

Other

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

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.

Time frame: conclusion of the study

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Important dates

Study start: 2003
Primary completion: 2023
Study completion: 2023
First posted: Feb 11, 2008
Registry last updated: Mar 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed