Status:

COMPLETED

DNA Repair, p53 and Apoptosis Phenotypes in Lung Cancer

Lead Sponsor:

National Cancer Institute (NCI)

Conditions:

Lung Neoplasms

Eligibility:

All Genders

18-90 years

Brief Summary

The Laboratory of Human Carcinogenesis and the Pharmocogenetics Section of the Genetic Epidemiology Branch will conduct a lung cancer case-control study in Baltimore, Maryland. The primary hypothesis ...

Detailed Description

Background: The Laboratory of Human Carcinogenesis is conducting an observational non-small cell lung cancer (NSCLC) case-control study in Baltimore, MD. This molecular epidemiology study was develop...

Eligibility Criteria

Inclusion

  • INCLUSION CRITERIA:
  • Case Subject Selection:
  • Diagnosis of non-small cell lung cancer made pathologically (with confirmation by a second pathologist).
  • Must reside in Baltimore city or contiguous metropolitan counties, Prince George's county or Anne Arundel county.
  • Have a residential working phone within their home.
  • Be born in the United States.
  • Speak English well enough to be interviewed.
  • Be physically and mentally capable of performing the interview (i.e., must be able to hear the interviewer, mentally comprehend the interviewers questions and verbally respond).
  • Never have been interviewed as a control for the study.
  • Consent by the physician from the clinic where the subject was identified, or listed as the treating physician by the tumor registry or surgical pathology report.
  • Report of a positive LDCT screen by a physician
  • Hospital-Based Control Selection:
  • Stratified to frequency match cases by age (5 year intervals), gender, race, smoking (20 pack year intervals -- non-smokers, 0-20, 20-40, 40-60 and greater than 60 and ex-smokers \[greater than 5 yrs\]) and hospital.
  • Must reside in Baltimore city, contiguous metropolitan counties, Prince George's county or Anne Arundel county.
  • Have a residential working phone within their home.
  • Be born in the United States.
  • Speak English well enough to be interviewed.
  • Be physically and mentally capable of performing the interview (i.e., must be able to hear the interviewer, mentally comprehend the interviewers questions and verbally respond).
  • Never have been interviewed as a control for the study.
  • Physician consent by physician from clinic with subject is identified.
  • Selection of Population-Based Controls:
  • Stratified to match cases by age (5 year intervals), gender, and race.
  • Must reside in Maryland
  • Have a residential working phone within their home.
  • Be born in the United States.
  • Speak English well enough to be interviewed.
  • Be physically and mentally capable of performing the interview (i.e., must be able to hear the interviewer, mentally comprehend the interviewers' questions and verbally respond).
  • Never been interviewed as a control for the study.
  • EXCLUSION CRITERIA:
  • Case Subject Selection:
  • More than 6 months after initial diagnosis.
  • Currently residing in an institution such as prison, nursing home or shelter.
  • Severely ill in an intensive care unit (after discharge from ICU, then can be reconsidered).
  • Subjects is unable to give informed consent.
  • Hospital-Based Control Selection:
  • History of cancer other than non-melanotic skin cancer or in situ cervical cancer.
  • Currently residing in an institution such as a prison, nursing home or shelter.
  • Severely ill in an intensive care unit (after discharge from ICU, the can be reconsidered).
  • Subject is unable to give informed consent.
  • Known diagnosis of HIV, hepatitis B or C.
  • Selection of Population-Based Controls:
  • History of cancer other than non-melanotic skin cancer or in situ cervical cancer.
  • Currently residing in an institution such as a prison, nursing home or shelter.
  • Subjects unable to give informed consent.

Exclusion

    Key Trial Info

    Start Date :

    June 2 1995

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ACTUAL

    End Date :

    May 6 2020

    Estimated Enrollment :

    5625 Patients enrolled

    Trial Details

    Trial ID

    NCT00339859

    Start Date

    June 2 1995

    End Date

    May 6 2020

    Last Update

    May 11 2020

    Active Locations (2)

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    Page 1 of 1 (2 locations)

    1

    University of Maryland, Baltimore

    Baltimore, Maryland, United States, 21201-1595

    2

    VA Hospital, Baltimore

    Baltimore, Maryland, United States, 21201