NCT00611598

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
218

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2003

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 11, 2003

Completed
5 years until next milestone

First Submitted

Initial submission to the registry

January 28, 2008

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 11, 2008

Completed
15.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 24, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 24, 2023

Completed
Last Updated

March 29, 2023

Status Verified

March 1, 2023

Enrollment Period

20.1 years

First QC Date

January 28, 2008

Last Update Submit

March 28, 2023

Conditions

Lung CancerSingle Primary Lung CancerSecond Primary Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • To determine the association between cellular DNA repair and genetic alterations in DNA repair and associated pathways.

    conclusion of the study

Study Arms (2)

1

second primary lung cancer

Other: Blood draw and Questionnaires

2

single primary lung cancer

Other: Blood draw and Questionnaires

Interventions

Blood draw and QuestionnairesOTHER

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.

1

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

MSKCC Clinic

You may qualify 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.
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

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.

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Blood Specimen CollectionSurveys and Questionnaires

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative TechniquesData CollectionEpidemiologic MethodsHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Irene Orlow, PhD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2008

First Posted

February 11, 2008

Study Start

February 11, 2003

Primary Completion

March 24, 2023

Study Completion

March 24, 2023

Last Updated

March 29, 2023

Record last verified: 2023-03

Locations

US(1)