DNA Repair and Genetic Susceptibility to Lung Cancer | NCT00611598

Studies
DNA Repair and Genetic Susceptibility to Lung Cancer

NCT00611598

Sponsor

Memorial Sloan Kettering Cancer Center

Status

Completed

Last Update Posted

Mar 29, 2023Actual

Enrollment

218Actual

Phase

Not provided

Conditions

Lung Cancer
Single Primary Lung Cancer
Second Primary Lung Cancer

Interventions

Blood draw and Questionnaires
Blood draw and Questionnaires

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 11, 2003Actual

Primary Completion Date

Mar 24, 2023Actual

Completion Date

Mar 24, 2023Actual

First Submitted Date

Jan 28, 2008

First Submission Date that Met QC Criteria

Feb 8, 2008

First Posted Date

Feb 11, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 28, 2023

Last Update Posted Date

Mar 29, 2023Actual

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

218Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		second primary lung cancer	Other: Blood draw and Questionnaires
2		single primary lung cancer	Other: Blood draw and Questionnaires

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	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.		conclusion of the study

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

MSKCC Clinic

Sampling Method

Non-Probability Sample

ID	Term
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

ID	Term
D001800	Blood Specimen Collection
D011795	Surveys and Questionnaires

ID	Term
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis