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CompletedNCT00923884Updated Oct 9, 2019

Prospective Analysis of Genotypes in Adults Undergoing Therapy for Lung Cancer

An observational study in Carcinoma, Non-Small Cell Lung and Carcinoma, Small-Cell Lung, sponsored by National Cancer Institute (NCI). Completed at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2019-10-09.

Sponsored by National Cancer Institute (NCI) · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
546
Ages
18 Years to 100 Years
Sex
All
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Study summary

Background:

  • 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.

Objectives:

  • 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.

Eligibility:

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

Design:

  • 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.
Read the detailed description

Background:

  • 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.

Objectives:

  • 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.

Eligibility:

  • 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).

Design:

  • 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.

02

Conditions studied

  • Carcinoma, Non-Small Cell Lung
  • Carcinoma, Small-Cell Lung

Keywords

  • NSCLC
  • Genotype
  • SCLC
  • Lung Cancer
  • Non-Small Cell Lung Cancer
  • Small Cell Lung Cancer
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In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's enrollment of 546 is above the median of 149 across 1,175 observational studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

National Cancer Institute (NCI) is the lead sponsor of 3,506 studies on the registry; 334 are open to participants now.

Of its 402 completed or terminated interventional studies of FDA-regulated products, 365 (91%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Patients 18 years of age and older are eligible.

    1. 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).
    2. Patients must have a performance status of ECOG 0, 1, 2, or 3 for admission to this protocol.
    3. Patients with a current diagnosis of or a prior history of other cancers may be included onto this protocol.
    4. Patients may have either normal organ function or impaired organ function.

Exclusion criteria

EXCLUSION CRITERIA:

  1. Children will not be eligible.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
546 participants (actual)
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What researchers measure

Primary outcomes

  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

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Study locations

1 site
  • National Institutes of Health Clinical Center, 9000 Rockville Pike
    Bethesda, Maryland 20892, United States
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References and documents

Publications

  • Jemal A, Siegel R, Ward E, Hao Y, Xu J, Murray T, Thun MJ. Cancer statistics, 2008. CA Cancer J Clin. 2008 Mar-Apr;58(2):71-96. doi: 10.3322/CA.2007.0010. Epub 2008 Feb 20. PubMed 18287387 ↗
  • Arriagada R, Bergman B, Dunant A, Le Chevalier T, Pignon JP, Vansteenkiste J; International Adjuvant Lung Cancer Trial Collaborative Group. Cisplatin-based adjuvant chemotherapy in patients with completely resected non-small-cell lung cancer. N Engl J Med. 2004 Jan 22;350(4):351-60. doi: 10.1056/NEJMoa031644. PubMed 14736927 ↗
  • Schiller JH, Harrington D, Belani CP, Langer C, Sandler A, Krook J, Zhu J, Johnson DH; Eastern Cooperative Oncology Group. Comparison of four chemotherapy regimens for advanced non-small-cell lung cancer. N Engl J Med. 2002 Jan 10;346(2):92-8. doi: 10.1056/NEJMoa011954. PubMed 11784875 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 9, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00923884
Lead sponsor
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Jun 18, 2009
Start date
Mar 18, 2009
Completion
Apr 20, 2018
Last update
Oct 9, 2019

Study contacts

Arun Rajan, M.D.
principal investigator · National Cancer Institute (NCI)
View the source record on ClinicalTrials.gov ↗

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