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DNA Repair, p53 and Apoptosis Phenotypes in Lung Cancer


N/A
18 Years
N/A
Open (Enrolling)
Both
Lung Cancer

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Trial Information

DNA Repair, p53 and Apoptosis Phenotypes in Lung Cancer


The Laboratory of Human Carcinogenesis is conducting an observational lung cancer
case-control study in Baltimore, MD. This molecular epidemiology study has been specifically
developed to test the reliability and validity of the mutagen sensitivity assay, where a
case-control study is needed to assess the possibility of case bias (i.e., results vary due
to the concurrent presence of lung cancer rather than risk). Importantly, this protocol
establishes a resource that allows for the validation of these assays and also for the study
of other biomarkers and gene-environment interactions. In 2010, IRB approval was received
to include this study in a multi-institution genome-wide association study (GWAS) of lung
cancer in African Americans. The target accrual number is 4000 total subjects, consisting of
360 cases of each gender in African Americans and 640 cases for each gender in Caucasians.
An equal number of controls will be selected for each category of cases based on the
combination of gender and race. Upon recruitment, cases and controls receive a structured,
in person interview assessing prior medical and cancer history, tobacco use, alcohol use,
current medications, occupational history, family medical history, menstrual history and
estrogen use, recent nutritional supplements and caffeine intake, and socioeconomic status.
Specimen collection consists of a one-time blood sample and/or mouthwash to collect cheek
cells (oral cells) and a one-time urine sample. In addition, cancer and surrounding
non-cancer tissue that was surgically removed and not needed for diagnosis may be obtained
for cases, as well as current medical information from medical records. The phenotypic
markers to be studied will assess proficiency of DNA repair by using lymphocyte cultures
exposed in vitro to radiation, bleomycin, benzo(a)pyrene-diol-expoxide and then measuring
induction of chromosomal aberrations, p53 induction and apoptosis. DNA from buffy coats or
cheek cells will be used for analysis of genetic polymorphism in the form of Single
Nucleotide Polymorphisms (SNPs) in genes involved in DNA repair, innate immunity, cell cycle
control, angiogenesis, apoptosis, cytokines, nicotine addiction, inflammation, hormone
metabolism and microRNA. Tumors from cases will be evaluated for estrogen and progesterone
receptors. Urine, plasma and serum samples will be analyzed using an untargeted metabolomics
approach.

PRIMARY OBJECTIVES:

- To determine if mutagen sensitivity, p53 induction, and apoptosis in cultured
lymphocytes are predictive of lung cancer risk.

- To investigate and develop phenotypic or predictive markers of lung cancer risk and
survival, based on mutagen sensitivity, polymorphic markers, gene expression, and
metabolomics.

- To determine the relationship between sex-steroid metabolism, estrogen exposure, and
lung cancer risk.

ELIGIBILITY:

- Meets one of the following criteria:

- Histologically confirmed non-small cell lung cancer (case), diagnosed within the past 6
months.

- Frequency matched to cases according to age (5-year intervals), gender, and race
(population-based control).

- Resides in the state of Maryland.

- Subject Characteristics:

- Speaks English well enough to be interviewed

- Born in the United States

- 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)

- Has never been interviewed as a control for this study

- Does not currently reside in an institution such as a prison, nursing home, or shelter

- No history of cancer other than nonmelanoma skin cancer or carcinoma in situ of the
cervix (population-based control)

- Has a residential working phone within the home (population-based control)

Inclusion Criteria


- INCLUSION CRITERIA:

Case Subject Selection:

Diagnosis of non-small cell lung cancer made pathologically (with confirmation by a second
pathologist).

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 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.

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 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 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.

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.

Type of Study:

Observational

Study Design:

N/A

Principal Investigator

Ana I Robles, Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Institute (NCI)

Authority:

United States: Federal Government

Study ID:

999998027

NCT ID:

NCT00339859

Start Date:

June 1995

Completion Date:

Related Keywords:

  • Lung Cancer
  • Genetic Risk Factors
  • Molecular Epidemiology
  • Carcinogenesis Metabolism
  • Gender
  • Race
  • Lung Cancer
  • Lung Neoplasms

Name

Location

Johns Hopkins UniversityBaltimore, Maryland  21205
Sinai Hospital of BaltimoreBaltimore, Maryland  21225
University of Maryland, BaltimoreBaltimore, Maryland  21201-1595