EVIDENCEA Non-Interventional, Registry Study for Chinese Gastric Cancer Patients With HER2 Status: Clinical and Pathological Characteristics, Treatment Patterns and Clinical Outcomes (EVIDENCE)
Drug Data
Collected from today forward - ProspectiveDigestive System Diseases+5
+ Digestive System Neoplasms
+ Gastrointestinal Diseases
Cohort
Tracking disease incidence in order to identify risk factors and understand disease progression over time.Summary
Study start date: April 25, 2013
Actual date on which the first participant was enrolled.This prospective, multi-center, non-interventional study will evaluate the efficacy and safety of trastuzumab in routine clinical practice in Chinese participants with gastric or gastro-oesophageal cancer. The study will be conducted in 5 cohorts and eligible participants will be enrolled and assigned to the various cohorts according to human epidermal growth factor receptor 2 (HER2) status, disease stage and treatment with trastuzumab according to physician's decision. Treatment patterns and clinical outcomes in participants with gastric cancer in China will be evaluated. The total study duration is 60 months.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.1600 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Cohort
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: General Inclusion Criteria: Histologically confirmed cancer of the stomach or gastro-oesophageal junction or recurrent disease within 6 months before the date of recruitment Documented participant with trackable medical records HER2 status by immunohistochemistry (IHC) is known Specific Inclusion Criteria: Cohort I/II/IV: Participants with mGC: with recurrent or metastatic disease or with inoperable locally advanced disease Cohort III/V: Participants with operable non-mGC: TxNxM0 (according to American Joint Committee on Cancer [AJCC] edition 7th) Exclusion Criteria: Participants receiving regimen in a blinded trial
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.5 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 81 locations
Cancer Hospital Chinese Academy of Medical Sciences.
Beijing, ChinaPeking University First Hospital
Beijing, ChinaThe Affiliated Hospital of Military Medical Sciences(The 307th Hospital of Chinese PLA)
Beijing, China