Prospective Analysis of Genotypes in Adults Undergoing Therapy for Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00923884
Recruitment Status : Completed
First Posted : June 18, 2009
Last Update Posted : April 24, 2018
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

Brief Summary:


  • The Lung Cancer section of the National Cancer Institute s Medical Oncology Branch is running a study to better understand which genes might be important in patients who are undergoing therapy for lung cancer.


  • To find out if differences (also called polymorphisms) in specific genes lead to differences in outcomes (such as treatment success and survival rates) for patients who have been diagnosed with lung cancer.
  • To establish a repository of genetic information for future studies of these differences and their relation to lung cancer.


  • Any individual who has been diagnosed with lung cancer and is being treated through the National Cancer Institute.


  • After entrance in this study, patients will provide information to the researchers on age, gender, race/ethnicity, treatments received and response to treatments, and other specific information about their disease. This information will be kept confidential.
  • Approximately half a tablespoon of blood will be drawn.
  • Patients will be treated for lung cancer with normal treatment methods, as if they had not been enrolled in the study
  • Some patients may be offered the option of enrolling in separate research protocols for cancer treatment, involving chemotherapy, surgery, or radiation.

Condition or disease
Carcinoma, Non-Small Cell Lung Carcinoma, Small-Cell Lung

Detailed Description:


  • Lung cancer is the leading cause of cancer deaths among men and women worldwide.
  • Despite modern surgical, radiation, and chemotherapeutic interventions, the prognosis for patients with lung cancer remains poor, with an overall cure rate of less than 15%.
  • Genetic polymorphisms in drug-metabolizing enzymes, transporters, growth factor and hormonal receptors, DNA repair enzymes, and transcription factors might affect an individual s response to chemotherapy and radiation.
  • Interindividual differences in efficacy and toxicity of cancer chemotherapy and radiation are especially important given the narrow therapeutic index of these modalities.
  • Many of these differences have not been extensively explored in patients with lung cancer.


  • To better understand the genotype-phenotype relationship between genetic polymorphisms and clinical outcomes, with a focus on overall survival, following lung cancer therapy.
  • To better understand differences in outcome between Caucasian and African American patients being treated for lung cancer as a function of genotype.
  • To establish a DNA repository for the investigation of polymorphisms related to outcomes in lung cancer.
  • To develop methodology for the isolation, enumeration and live cell culture of circulating tumor cells (CTC) from lung cancer patients with microfiltration devices.


- All individuals with the diagnosis of lung cancer being treated at the Washington D.C. Veterans Affairs Medical Center or the Medical Oncology Branch of the National Cancer Institute (NCI).


  • A single 7-ml sample of venous blood will be obtained from all patients enrolled onto this study, for isolation of DNA.
  • Two 5 ml samples of venous blood, drawn immediately following the 7 ml sample, will be obtained from all patients enrolled on this study at the NCI Clinical Center (only), for CTC studies.
  • Polymorphisms in the following genes: ABCB1, ABCG2, COMT, CYP17, CYP19, CYP1B1, CYP1A1, CYP1A2, CYP2C8, CYP2C9, CYP2J2, CYP3A4, CYP3A5, DPYD, EPHX2, ERalpha, ERbeta, ERCC1, ERCC2, GSTP1, HIF1A, MPO, MTHFR, NQO1, p53, PPARD, SLCO1B3, TYMS, UGT1A1, VEGF, VEGFR, EGFR, SLC28A1, CDA, XRCC1, OCT1, OCT2, CHRNA3 and CHRNA5 will be analyzed by the Clinical Pharmacology Program.
  • Methodology for the isolation, enumeration, and live cell culture of CTC with microfiltration devices will be developed by the NCI Genetics Branch.
  • Patients will be followed at the medical oncology clinic at the Washington DC VA Medical Center or the NCI and the following information will be recorded in a confidential database: age, gender, race/ethnicity, smoking history, histology, stage, treatment(s) received, response, toxicity, time to disease progression, time to death.
  • Associations between genetic polymorphisms and response to therapy, toxicity and clinical outcomes will be analyzed.
  • The results of the CTC studies will be applied to the initial development and clinical

validation of CTC technology and lung cancer assays.

Study Type : Observational
Actual Enrollment : 546 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Analysis of Genotypes in Adults Undergoing Therapy for Lung Cancer
Study Start Date : March 18, 2009
Study Completion Date : April 20, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Primary Outcome Measures :
  1. Evaluation of the association between polymorphisms in the enzymes ABCB1, CYP1B1, and CYP19 and clinical outcomes, with overall survival of greatest interest, in patients undergoing treatment for lung cancer. [ Time Frame: Death or the conclusion of a 5-year follow-up period ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

    1. Patients 18 years of age and older are eligible.
    2. Histologic diagnosis of primary lung carcinoma. For non small cell lung cancer, patients can be stage I to IV, and receive any treatment (surgical resection, chemotherapy, radiation, molecularly targeted therapy). For small cell lung cancer, patients can be limited or extensive stage and receive any treatment (surgical resection, chemotherapy, radiation, molecularly targeted therapy).
    3. Patients must have a performance status of ECOG 0, 1, 2, or 3 for admission to this protocol.
    4. Patients with a current diagnosis of or a prior history of other cancers may be included onto this protocol.
    5. Patients may have either normal organ function or impaired organ function.


1. Children will not be eligible.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00923884

United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Cancer Institute (NCI)
Principal Investigator: Arun Rajan, M.D. National Cancer Institute (NCI)

Responsible Party: National Cancer Institute (NCI) Identifier: NCT00923884     History of Changes
Other Study ID Numbers: 090103
First Posted: June 18, 2009    Key Record Dates
Last Update Posted: April 24, 2018
Last Verified: April 20, 2018

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):
Lung Cancer
Non-Small Cell Lung Cancer
Small Cell Lung Cancer

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Carcinoma, Small Cell
Small Cell Lung Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms