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Trial record 19 of 87 for:    lung cancer AND risk factors

Iressa Case Control Study in Japan

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.
ClinicalTrials.gov Identifier: NCT00252759
Recruitment Status : Completed
First Posted : November 15, 2005
Last Update Posted : January 28, 2011
Sponsor:
Information provided by:

Study Description
Brief Summary:

The purposes of this study are:

  • To estimate the relative risk of ILD in advanced/recurrence NSCLC patients treated with gefitinib as compared to other chemotherapy treatment, and to assess the risk factors for ILD in advanced/recurrence NSCLC patients undergoing treatment
  • To provide an estimate of the incidence of ILD in a group of advanced/recurrence NSCLC patients undergoing treatment

Condition or disease Phase
Non-small Cell Lung Cancer Phase 4

Study Design

Study Type : Observational
Estimated Enrollment : 6000 participants
Time Perspective: Prospective
Official Title: A Nested Case-control Study to Determine the Relative Risk of and Risk Factors for Interstitial Lung Disease in a Cohort of NSCLC Patients Treated With and Without Gefitinib
Study Start Date : November 2003
Study Completion Date : February 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients
Criteria

Inclusion Criteria:

  • Advanced/recurrence NSCLC patients who have had one or more chemotherapy regimens.
  • Patients who are to be treated with gefitinib or chemotherapy
  • Cohort: All advanced/recurrence NSCLC patients participating in this post-marketing clinical study

Exclusion Criteria:

  • Patients judged by the investigator(s) to have ILD (provisional cases) among those registered in the cohort OR Randomly selected patients without ILD (controls) for each provisional case
  • Case-control study: Patients enrolled in the case-control study; all consenting patients with ILD as cases and approximately 4 times as many consenting patients without ILD as controls randomly selected from the cohort
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT00252759


Locations
Japan
Research Site
Nagoya, Aichi, Japan
Research Site
Okazaki, Aichi, Japan
Research Site
Toyoake, Aichi, Japan
Research Site
Imba-gun, Chiba, Japan
Research Site
Kashiwa, Chiba, Japan
Research Site
Matsuyama, Ehime, Japan
Research Site
Kitakyushu, Fukuoka, Japan
Research Site
Asahikawa, Hokkaido, Japan
Research Site
Sapporo, Hokkaido, Japan
Research Site
Akashi, Hyogo, Japan
Research Site
Kobe, Hyogo, Japan
Research Site
Kanazawa, Ishikawa, Japan
Research Site
Isehara, Kanagawa, Japan
Research Site
Sagamihara, Kanagawa, Japan
Research Site
Yokohama, Kanagawa, Japan
Research Site
Sendai, Miyagi, Japan
Research Site
Omura, Nagasaki, Japan
Research Site
Tenri, Nara, Japan
Research Site
Ginowan, Okinawa, Japan
Research Site
Habikino, Osaka, Japan
Research Site
Izumisano, Osaka, Japan
Research Site
Osakasayama, Osaka, Japan
Research Site
Sakai, Osaka, Japan
Research Site
Toyonaka, Osaka, Japan
Research Site
Tokyo, Ota, Japan
Research Site
Otsu, Shiga, Japan
Research Site
Sunto-gun, Shizuoka, Japan
Research Site
Bunkyo-ku, Tokyo, Japan
Research Site
Bunkyo, Tokyo, Japan
Research Site
Kiyose, Tokyo, Japan
Research Site
Minato-ku, Tokyo, Japan
Research Site
Mitaka, Tokyo, Japan
Research Site
Shinjuku, Tokyo, Japan
Research Site
Toshima-ku, Tokyo, Japan
Research Site
Fukuoka, Japan
Research Site
Gifu, Japan
Research Site
Hiroshima, Japan
Research Site
Kumamoto, Japan
Research Site
Kyoto, Japan
Research Site
Nagasaki, Japan
Research Site
Niigata, Japan
Research Site
Okayama, Japan
Research Site
Osaka, Japan
Research Site
Toyama, Japan
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca Japan Medical Director, MD AstraZeneca
More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00252759     History of Changes
Other Study ID Numbers: D791AL00002
V-15-33
OZV1533
First Posted: November 15, 2005    Key Record Dates
Last Update Posted: January 28, 2011
Last Verified: January 2011

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