DNA Repair and Genetic Susceptibility to Lung Cancer

March 28, 2023 updated by: Memorial Sloan Kettering Cancer Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

218

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

MSKCC Clinic

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
conclusion of the study

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 11, 2003

Primary Completion (Actual)

March 24, 2023

Study Completion (Actual)

March 24, 2023

Study Registration Dates

First Submitted

January 28, 2008

First Submitted That Met QC Criteria

February 8, 2008

First Posted (Estimate)

February 11, 2008

Study Record Updates

Last Update Posted (Actual)

March 29, 2023

Last Update Submitted That Met QC Criteria

March 28, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 03-003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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