A Study on the Long Term Survivals in an Expand Access Program (EAP) of Iressa
NCT01000740 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 59
Last updated 2010-05-21
Summary
The primary objective is to describe the quality of life of long-term survivors who are not terminated from the EAP.
Conditions
Interventions
- GENETIC
-
EGFR Mutation Test
Explore the EGFR mutation status from both tumour tissue sample and the free DNA in the peripheral blood using appropriate method(s) which may include ARMS assay, ME-PCR coupled sequencing and regular sequencing.
- GENETIC
-
Ki-67 protein expression
Ki-67 protein expression in tissue will be analysed by IHC method.
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Karen Atkin · AstraZeneca
-
Louis Zhang · AstraZeneca
-
Longyun Li · Peking Union Medical College Hospital
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-08-31
- Primary Completion
- 2010-04-30
- Completion
- 2010-04-30
Countries
- China
Study Locations
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