NCT00923884

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
546

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 18, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 17, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 18, 2009

Completed
8.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2018

Completed
Last Updated

October 9, 2019

Status Verified

April 20, 2018

First QC Date

June 17, 2009

Last Update Submit

October 8, 2019

Conditions

Carcinoma, Non-Small Cell LungCarcinoma, Small-Cell Lung

Keywords

NSCLCGenotypeSCLCLung CancerNon-Small Cell Lung CancerSmall Cell Lung Cancer

Outcome Measures

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.

    Death or the conclusion of a 5-year follow-up period

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients 18 years of age and older are eligible.
  • 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).
  • Patients must have a performance status of ECOG 0, 1, 2, or 3 for admission to this protocol.
  • Patients with a current diagnosis of or a prior history of other cancers may be included onto this protocol.
  • Patients may have either normal organ function or impaired organ function.

You may not qualify if:

  • \. Children will not be eligible.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • 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.

    PMID: 18287387BACKGROUND

  • 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.

    PMID: 14736927BACKGROUND

  • 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.

    PMID: 11784875BACKGROUND

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungSmall Cell Lung CarcinomaLung Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Arun Rajan, M.D.

    National Cancer Institute (NCI)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2009

First Posted

June 18, 2009

Study Start

March 18, 2009

Study Completion

April 20, 2018

Last Updated

October 9, 2019

Record last verified: 2018-04-20

Locations

US(1)