DNA Analysis in Predicting Lung Cancer Risk - Full Text View

Sponsor:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00559325

Purpose

RATIONALE: Studying samples of blood, urine, and tissue from patients with lung cancer and from other participants in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict risk for developing lung cancer.

PURPOSE: This clinical trial is studying the DNA in blood, urine, and tissue samples from patients with lung cancer and from other participants.

Condition	Intervention
Lung Cancer	Genetic: gene expression analysis Genetic: mutation analysis Genetic: polymorphism analysis Genetic: proteomic profiling Other: laboratory biomarker analysis Other: questionnaire administration Procedure: evaluation of cancer risk factors

Study Type:	Observational
Official Title:	DNA Repair, p53 and Apoptosis Phenotypes in Lung Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Prediction of lung cancer risk based on mutagen sensitivity, p53 induction, and apoptosis in cultured lymphocytes
Development of phenotypic or predictive markers of lung cancer, including mutagen sensitivity, DNA damage-induced cell cycle checkpoints, and serum proteomics

Secondary Outcome Measures:

Gene-neuro-behavioral interactions for smoking addiction in the control groups
Relationship between sex-steroid metabolism, estrogen exposure, and lung cancer risk

Estimated Enrollment:	3000
Study Start Date:	June 1995
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Primary

To determine if mutagen sensitivity, p53 induction, and apoptosis in cultured lymphocytes is predictive of lung cancer risk.
To investigate and develop phenotypic or predictive markers of lung cancer, including mutagen sensitivity, DNA damage-induced cell cycle checkpoints, and serum proteomics.

Secondary

To demonstrate gene-neuro-behavioral interactions for smoking addiction in the control groups.
Determine the relationship between sex-steroid metabolism, estrogen exposure, and lung cancer risk.

OUTLINE: Cases and controls undergo a structured, in-person interview assessing prior medical history and cancer history, tobacco use, alcohol use, current medications, occupational history, family medical history, menstrual history and estrogen use, recent nutritional supplement use, caffeine intake, and socioeconomic status.

Cases and controls also undergo blood and urine sample collection for DNA analysis. The phenotypic markers studied will assess DNA repair with cellular response by using lymphocyte cultures exposed in vitro to radiation, bleomycin, and benzo(a)pyrene-diol-epoxide and measuring induction of chromosomal aberrations, p53 induction, and apoptosis. DNA from cases and controls are also used for genetic polymorphism analysis of carcinogen metabolism, and those related to the dopaminergic system and nicotinic receptors. Previously collected tumor tissue samples from cases are evaluated for estrogen and progesterone receptors.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

DISEASE CHARACTERISTICS:

Meets 1 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, race, smoking status, and hospital (hospital control)
- Frequency matched to cases according to age (5-year intervals), gender, and race (population-based control)
Resides in Baltimore City or contiguous metropolitan counties (i.e., Prince George's County or Anne Arundel County)

PATIENT CHARACTERISTICS:

Has a residential working phone within the home
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 severe illness requiring an intensive care unit (ICU) (case or hospital control)
- May be eligible for study participation after discharge from ICU
No known diagnosis of HIV or hepatitis B or C (case or hospital control)
No history of cancer other than nonmelanoma skin cancer or carcinoma in situ of the cervix (hospital control or population control)

PRIOR CONCURRENT THERAPY:

Not specified

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00559325

Locations

United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office	Recruiting
Bethesda, Maryland, United States, 20892-1182
Contact: Clinical Trials Office - Warren Grant Magnusen Clinical Center 888-NCI-1937

Sponsors and Collaborators

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Elise D. Bowman

National Cancer Institute (NCI)

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

Pine SR, Mechanic LE, Ambs S, Bowman ED, Chanock SJ, Loffredo C, Shields PG, Harris CC. Lung cancer survival and functional polymorphisms in MBL2, an innate-immunity gene. J Natl Cancer Inst. 2007 Sep 19;99(18):1401-9. Epub 2007 Sep 11.

Pine SR, Mechanic LE, Bowman ED, Welsh JA, Chanock SC, Shields PG, Harris CC. MDM2 SNP309 and SNP354 are not associated with lung cancer risk. Cancer Epidemiol Biomarkers Prev. 2006 Aug;15(8):1559-61.

Zheng YL, Loffredo CA, Alberg AJ, Yu Z, Jones RT, Perlmutter D, Enewold L, Krasna MJ, Yung R, Shields PG, Harris CC. Less efficient g2-m checkpoint is associated with an increased risk of lung cancer in African Americans. Cancer Res. 2005 Oct 15;65(20):9566-73.

Zheng YL, Loffredo CA, Yu Z, Jones RT, Krasna MJ, Alberg AJ, Yung R, Perlmutter D, Enewold L, Harris CC, Shields PG. Bleomycin-induced chromosome breaks as a risk marker for lung cancer: a case-control study with population and hospital controls. Carcinogenesis. 2003 Feb;24(2):269-74. Erratum in: Carcinogenesis. 2003 Aug;24(8):1425.

Mechanic LE, Bowman ED, Welsh JA, Khan MA, Hagiwara N, Enewold L, Shields PG, Burdette L, Chanock S, Harris CC. Common genetic variation in TP53 is associated with lung cancer risk and prognosis in African Americans and somatic mutations in lung tumors. Cancer Epidemiol Biomarkers Prev. 2007 Feb;16(2):214-22.

Study ID Numbers:	CDR0000566029, NCI-OH98-C-N027
Study First Received:	November 15, 2007
Last Updated:	June 9, 2009
ClinicalTrials.gov Identifier:	NCT00559325 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

non-small cell lung cancer

Additional relevant MeSH terms:

Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site

Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases

ClinicalTrials.gov processed this record on November 30, 2009