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OpenTrials
Completed

NCT Number: NCT00252759

Iressa Case Control Study in Japan

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

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Nagoya, Aichi-ken, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2003
Study completion
2006
First posted
Nov 15, 2005
Registry last updated
Jan 28, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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