A Non-Interventional Study of Treatment Pattern and Clinical Outcomes in Chinese Participants With Gastric Cancer
EVIDENCE
A Non-Interventional, Registry Study for Chinese Gastric Cancer Patients With HER2 Status: Clinical and Pathological Characteristics, Treatment Patterns and Clinical Outcomes (EVIDENCE)
1 other identifier
observational
1,600
1 country
81
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2013
Longer than P75 for all trials
81 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 22, 2013
CompletedFirst Posted
Study publicly available on registry
April 25, 2013
CompletedStudy Start
First participant enrolled
April 25, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 9, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 9, 2018
CompletedMarch 29, 2018
March 1, 2018
4.7 years
April 22, 2013
March 28, 2018
Conditions
Outcome Measures
Primary Outcomes (6)
Overall Survival
Baseline up to death (up to approximately 5 years)
Percentage of Participants With Best Overall Response of Complete Response (CR) or Partial Response (PR), as Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST V1.1) Criteria
Baseline up to disease progression or death, whichever occurs first (up to approximately 5 years)
Cohort I, II, IV: Time to Treatment Failure (TTF), as Assessed by the Investigator Using RECIST V1.1 Criteria
Baseline up to disease progression or death, whichever occurs first (up to approximately 5 years)
Cohort I, II, IV: Progression-Free Survival (PFS), as Assessed by the Investigator Using RECIST V1.1 Criteria
Baseline up to disease progression or death, whichever occurs first (up to approximately 5 years)
Cohort III, V: Event-Free Survival (EFS), as Assessed by the Investigator Using RECIST V1.1 Criteria
Baseline up to disease recurrence or progression or death, whichever occurs first (up to approximately 5 years)
Cohort III, V: Disease-Free Survival (DFS), as Assessed by the Investigator Using RECIST V1.1 Criteria
Baseline up to disease progression or death, whichever occurs first (up to approximately 5 years)
Secondary Outcomes (4)
Cohort I: Percentage of Participants With Non-Serious Adverse Events and Serious Adverse Events
Baseline up to approximately 5 years
Percentage of Participants Treated with Various Initial and Subsequent Therapies (Chemotherapy, Targeted, or Investigational Treatments)
Baseline up to approximately 5 years
Cohort II: Percentage of Healthcare Professionals (HCPs) Who Recommend Treatment According to Guideline
Baseline up to first follow-up (up to approximately 5 years)
Cohort II: Percentage of Participants Who Decline to the Recommendation Categorized by Reasons
Baseline up to first follow-up (up to approximately 5 years)
Study Arms (5)
Cohort I: HER2-Positive mGC Treated With Trastuzumab
HER2-positive metastatic gastric cancer (mGC) participants who are treated with trastuzumab will be included in this cohort. As this is an observational study, treatment schedule will be at the clinician's discretion in accordance with routine care practice and not dictated by the protocol.
Cohort II: HER2-Positive mGC not Treated With Trastuzumab
HER2-positive mGC participants who are not treated with trastuzumab will be included in this cohort.
Cohort III: HER2-Positive non-mGC
HER2-positive non-mGC participants will be included in this cohort.
Cohort IV: HER2-Negative mGC
HER2-negative mGC participants will be included in this cohort.
Cohort V: HER2-Negative non-mGC
HER2-negative non-mGC participants will be included in this cohort.
Interventions
Trastuzumab administered in accordance with routine care practice.
Eligibility Criteria
Participants with gastric or gastro-oesophageal junction cancers in China
You may qualify if:
- 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
- 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)
You may not qualify if:
- Participants receiving regimen in a blinded trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (81)
Anyang Tumor Hosptial
Anyang, China
Cancer Hospital Chinese Academy of Medical Sciences.
Beijing, 100021, China
Peking University First Hospital
Beijing, 100034, China
The Affiliated Hospital of Military Medical Sciences(The 307th Hospital of Chinese PLA)
Beijing, 100071, China
Peking University Third Hospital
Beijing, 100083, China
Beijing Cancer Hospital
Beijing, 100142, China
Beijing Union Hospital
Beijing, 100730, China
General Hospital of Chinese PLA; Department of Hematology
Beijing, 100853, China
the First Hospital of Jilin University
Changchun, 130021, China
Hu Nan Provincial Cancer Hospital
Changsha, 410006, China
The Second Xiangya Hospital of Central South University
Changsha, 410011, China
Changzhou First People's Hospital
Changzhou, 213003, China
Sichuan Provincial Cancer Hospital
Chengdu, 610041, China
West China Hospital, Sichuan University
Chengdu, 610041, China
Sichuan Provincial People's Hospital
Chengdu, 610072, China
Third Affiliated Hospital of Third Military Medical University
Chongqing, 400042, China
The First People's Hospital of Foshan
Foshan, 510000, China
Fujian Medical University Union Hospital
Fujian, 350001, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, 350005, China
Fujian Provincial Hospital
Fuzhou, China
Sun Yat-sen Memorial Hospital
Guangzhou, 510000, China
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, 510080, China
Nanfang Hospital, Southern Medical University
Guangzhou, 510515, China
Guizhou Provincial People's Hospital
Guiyang, 550002, China
Guizhou Cancer Hospital
Guiyang, 550004, China
Hainan provincial people's hospital
Haikou, 570311, China
Cancer Hospital of Hangzhou (Wushan District)
Hangzhou, 310002, China
Hangzhou First People's Hospital
Hangzhou, 310006, China
Harbin Medical University Cancer Hospital
Harbin, 150081, China
The First Affiliated Hospital of Anhui Medical University
Hefei, 230022, China
Inner Mongolia People's Hospital
Hohhot, 010017, China
Affiliated Hospital of Inner Mongolia Medical College
Hohhot, 010050, China
The First Affilliated Hospital of Kunming Medical College
Kunming, 650032, China
The First People's Hospital of Yunnan Province
Kunming, 650032, China
Yunnan Cancer Hospital
Kunming, 650118, China
The First Affiliated Hospital of Lanzhou University
Lanzhou, 730000, China
Gansu Cancer Hospital
Lanzhou, 730050, China
Taizhou Hospital of Zhejiang Province
Linhai, 317000, China
The First Affiliated Hospital of Henan UN of Science and Technology
Luoyang, 471003, China
The 1st Affiliated Hospital of Nanchang Unversity
Nanchang, 330006, China
The Second Affiliated Hospital to Nanchang University
Nanchang, 330006, China
Jiangxi Cancer Hospital; First department of abdominal surgery
Nanchang, 330029, China
Affiliated Hospital of North Sichuan Medical College
Nanchong, China
Nanjing 1st Hospital; Endocrinology Dept.
Nanjing, 210006, China
Jiangsu Cancer Hospital
Nanjing, 210009, China
Jiangsu Province Hospital
Nanjing, 210036, China
The 81st Hospital of P.L.A.
Nanjing, China
Affiliated Hospital of Nantong University
Nantong, 226001, China
Nan Tong Tumor Hospital
Nantong, China
The Affiliated Hospital of Medical College Qingdao University
Qingdao, 266003, China
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, 200025, China
Fudan University Shanghai Cancer Center
Shanghai, 200032, China
Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, 200127, China
Changhai Hospital of Shanghai
Shanghai, 200433, China
Changhai Hospital; Oncology
Shanghai, 200433, China
Shaoxing People's Hospital
Shaoxing, 312000, China
Liaoning cancer Hospital & Institute
Shenyang, 110042, China
Hebei Medical University Fourth Hospital;(Tumor Hospital of Hebei Province)
Shijiazhuang, 050035, China
First Affiliated Hospital of Soochow University
Suzhou, 215006, China
Shanxi Province Cancer Hospital
Taiyuan, China
Tianjin Medical University General Hospital
Tianjin (天津), 300052, China
The Tumor Hospital of Xinjiang Medical University
Ürümqi, 830000, China
The First Teaching Hospital of Xinjiang Medical University
Ürümqi, 830054, China
The Second Affiliated Hospital & Yuying Children's Hospital of Wenzhou Medical College
Wenzhou, 325000, China
Xiehe Hospital, Tongji Medical College Huazhong University of Science & Technology
Wuhan, 430022, China
Tongji Hosp, Tongji Med. Col, Huazhong Univ. of Sci. & Tech
Wuhan, 430030, China
Zhongnan Hospital of Wuhan University
Wuhan, 430071, China
Hubei Cancer Hospital
Wuhan, 430079, China
Wuxi No.4 People's Hospital
Wuxi, 310000, China
The First Affiliated Hospital of The Fourth Military Medical University (Xijing Hospital)
Xi'an, 710032, China
The Second Affiliated Hospital of The Fourth Military Medical University (Tangdu Hospital)
Xi'an, 710038, China
Shanxi Provincial People's Hospital
Xi'an, 710068, China
The First Affiliated Hospital of Xiamen University
Xiamen, 361003, China
Zhongshan Hospital Xiamen University
Xiamen, 361004, China
Xinxiang Central Hospital
Xinxiang, China
Northern Jangsu People's Hospital
Yangzhou, China
Zhangzhou Municipal Hospital of Fujian Province
Zhangzhou, 363000, China
Henan Provincial People's Hospital
Zhengzhou, 450003, China
Henan Cancer Hospital
Zhengzhou, 450008, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, 450052, China
Affiliated Hospital of Jiangsu University
Zhenjiang, 212001, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 22, 2013
First Posted
April 25, 2013
Study Start
April 25, 2013
Primary Completion
January 9, 2018
Study Completion
January 9, 2018
Last Updated
March 29, 2018
Record last verified: 2018-03