DNA Repair and Genetic Susceptibility to Lung Cancer - Full Text View

Purpose

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.

Condition	Intervention
Lung Cancer Single Primary Lung Cancer Second Primary Lung Cancer	Other: Blood draw and Questionnaires

MedlinePlus related topics:

Cancer Lung Cancer

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective

Official Title:	DNA Repair and Genetic Susceptibility to Lung Cancer

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To determine the association between cellular DNA repair and genetic alterations in DNA repair and associated pathways. [ Time Frame: conclusion of the study ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples With DNA

Biospecimen Description:

30 ml. Blood in heparinized, green top tubes.
Fresh tumor or normal tissue, when available.
Tissue or cells from routine bronchoscopy, when available.

Enrollment:	218
Study Start Date:	February 2003
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1 second primary lung cancer	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.
2 single primary lung cancer	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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

MSKCC Clinic

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00611598

Locations


United States, New York
	Memorial Sloan Kettering Cancer Center
	New York, New York, United States, 10065

Sponsors and Collaborators

Memorial Sloan-Kettering Cancer Center

University of New Mexico

Investigators


Principal Investigator:	Irene Orlow, PhD	Memorial Sloan-Kettering Cancer Center

More Information

Memorial Sloan-Kettering Cancer Center This link exits the ClinicalTrials.gov site

Responsible Party:	Memorial Sloan-Kettering Cancer Center ( Irene Orlow, PhD )
Study ID Numbers:	03-003
First Received:	January 28, 2008
Last Updated:	July 24, 2008
ClinicalTrials.gov Identifier:	NCT00611598
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Thoracic Neoplasms

Respiratory Tract Diseases

Disease Susceptibility

Lung Neoplasms

Lung Diseases

Genetic Predisposition to Disease

Additional relevant MeSH terms:

Respiratory Tract Neoplasms

Neoplasms

Disease Attributes

Neoplasms by Site

Pathologic Processes

ClinicalTrials.gov processed this record on October 15, 2008

Sponsors and Collaborators:	Memorial Sloan-Kettering Cancer Center University of New Mexico
Information provided by:	Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:	NCT00611598