This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Iressa Case Control Study in Japan

This study has been completed.
Information provided by:
AstraZeneca Identifier:
First received: November 14, 2005
Last updated: January 27, 2011
Last verified: January 2011

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 Phase
Non-small Cell Lung Cancer Phase 4

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Estimated Enrollment: 6000
Study Start Date: November 2003
Study Completion Date: February 2006

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00252759

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
Study Director: AstraZeneca Japan Medical Director, MD AstraZeneca
  More Information

Additional Information: Identifier: NCT00252759     History of Changes
Other Study ID Numbers: D791AL00002
Study First Received: November 14, 2005
Last Updated: January 27, 2011

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases processed this record on August 18, 2017