Prospective Analysis of Genotypes in Adults Undergoing Therapy for Lung Cancer

October 8, 2019 updated by: National Cancer Institute (NCI)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
546

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • National Institutes of Health Clinical Center, 9000 Rockville Pike

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 100 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • INCLUSION CRITERIA:

    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.

EXCLUSION CRITERIA:

1. Children will not be eligible.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
Death or the conclusion of a 5-year follow-up period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Cancer Institute (NCI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 18, 2009

Study Completion

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 20, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 17, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 17, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 18, 2009

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 9, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 8, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 20, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 090103
  • 09-C-0103

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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