DNA Repair and Genetic Susceptibility to Lung Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
University of New Mexico
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00611598
First received: January 28, 2008
Last updated: December 3, 2013
Last verified: December 2013
  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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: DNA Repair and Genetic Susceptibility to Lung Cancer

Resource links provided by NLM:


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
  • 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 2014
Estimated Primary Completion Date: September 2014 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00611598     History of Changes
Other Study ID Numbers: 03-003
Study First Received: January 28, 2008
Last Updated: December 3, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Disease Susceptibility
Lung Neoplasms
Genetic Predisposition to Disease
Disease Attributes
Pathologic Processes
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 24, 2014