DNA Repair and Genetic Susceptibility to Lung Cancer

Lung Cancer Clinical Trial

Official title:

DNA Repair and Genetic Susceptibility to Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00611598
• Other study ID #: 03-003
• Status: Completed
• Start date: February 11, 2003
• Est. completion date: March 24, 2023

Study information

• Verified date: March 2023
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 218
• Est. completion date: March 24, 2023
• Est. primary completion date: March 24, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Genetic Predisposition to Disease
• Lung Cancer
• Lung Neoplasms
• Second Primary Lung Cancer
• Single Primary Lung Cancer

Intervention

Other:
• 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.
• 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.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		conclusion of the study
Secondary	To determine the association between cellular DNA repair and genetic alterations in DNA repair and associated pathways.		conclusion of the study

External Links

•   Memorial Sloan-Kettering Cancer Center