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Effect Study of Clinical Outcomes of Traditional Chinese Medicine to Advanced Gastric Cancer by Propensity Score (ESCOTCMAGCPS)

This study is currently recruiting participants.
Verified October 2017 by Shanghai University of Traditional Chinese Medicine
Sponsor:
ClinicalTrials.gov Identifier:
NCT02781285
First Posted: May 24, 2016
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Shanghai Zhongshan Hospital
RenJi Hospital
Fudan University
ShuGuang Hospital
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Ruijin Hospital
Yunnan Provinical Hospital of Traditional Chinese Medicine
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Shaanxi Hospital of Traditional Chinese Medicine
Information provided by (Responsible Party):
Shanghai University of Traditional Chinese Medicine
  Purpose
The researching subject is aimed to obtain the clinical evidences (including real benefits, risks ,etc. ) of traditional Chinese medicine in the treatment of advanced gastric cancer by compared with the outcomes that not accept the traditional Chinese medicine. the subject acquires these clinical practices by using the methods of multicenter、persisting registry (the real world researching technology ) and propensity score.

Condition
Gastric Adenocarcinoma

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Effect Study of Clinical Outcomes of Traditional Chinese Medicine to Advanced Gastric Cancer by Propensity Score Through Registration

Resource links provided by NLM:


Further study details as provided by Shanghai University of Traditional Chinese Medicine:

Primary Outcome Measures:
  • The influences of traditional Chinese medicine standardized treatment on the overall survival (OS) of patients with advanced gastric cancer by the method of Propensity Score. [ Time Frame: two years ]
    Two years of continuous observation after the initial diagnosis of advanced gastric cancer with 725 cases .


Secondary Outcome Measures:
  • The influences of traditional Chinese medicine treatment but with standardization scheme on the overall survival (OS) of patients with advanced gastric cancer by the method of Propensity Score. [ Time Frame: two years ]
    Two years of continuous observation after the initial diagnosis of advanced gastric cancer with 375 cases.

  • The influences of Western Medicine treatment mainly by chemotherapy on the overall survival (OS) of patients with advanced gastric cancer by the method of Propensity Score. [ Time Frame: two years ]
    Two years of continuous observation after the initial diagnosis of advanced gastric cancer with 400 cases.


Estimated Enrollment: 1500
Actual Study Start Date: December 2014
Estimated Study Completion Date: December 2018
Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
1group one
patients with standard TCM diagnosis and treatment of gastric cancer
2 group two
patients take Chinese Medicine but not with standard TCM diagnosis and treatment of gastric cancer
3group three
patients take no Chinese Medicine

Detailed Description:

The purpose of this project is to further evaluate the role of traditional Chinese medicine in the treatment of advanced gastric cancer through clinical registration along with real world study.

The patients who suffer from advanced gastric cancer often have a very short time survival . Their total survival time is only 4.3 months after the best supportive care. At present palliative chemotherapy is still the main method for advanced gastric cancer .

In recent years, the results of international multi center phase III clinical trial show that the patients with combination chemotherapy have 8.6 months to 13.0 months survival time.

In China, the clinical curative effect of traditional Chinese medicine in the treatment of advanced gastric cancer has been part of affirmation. Some reports with large samples of clinical research show that the Traditional Chinese Medicine may prolong the survival and improve the quality of life in patients with advanced gastric cancer.

Real World Study emphasizes in epidemiological theories, clinical observational study, cross-sectional study and cohort study. The observational study of registry (registry study in clinical practice) is particularly widely used.

Clinical practice of traditional Chinese medicine in the treatment of advanced gastric cancer often relies on the accumulation of years of medical experiences and sometimes new treatment measures. There must be some objective evidences that with reasonable design, rigorous process, scientific statistics to evaluate the value of traditional Chinese medicine intervention in the comprehensive treatment of advanced gastric cancer patients in order to meet the needs of clinical practice and medical development in China.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Both: both female and male participants are being studied
Criteria

Inclusion Criteria:

  • gastric adenocarcinoma without operation or recurrence after operation or metastasis
  • diagnosed within three months
  • KPS score≥60
  • expected survival time was above 3 months
  • HB ≥80g/L 、WBC≥4.0×109/L、 N ≥2.0×109/L 、PLA ≥80×109/L
  • normal function with heart 、kidney and liver

Exclusion Criteria:

  • not gastric adenocarcinoma
  • simultaneous diagnosis with other malignant tumor
  • participate in clinical trials of new drugs not listed in China
  • combined with myocardial infarction, cerebral infarction, severe liver and kidney dysfunction, postoperative severe complications
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02781285


Contacts
Contact: zou yu ming, Ma. 15021827856 zoubush133136@hotmail.com
Contact: zhao ai guang, Dr. 13661472241 2538312201@qq.com

Locations
China, Shanghai
Longhua Hospital Recruiting
Shanghai, Shanghai, China, 20032
Contact: zou yu ming, Ma.    15021827856    zoubush133136@hotmail.com   
Contact: zhao ai guang, Dr.    13661472241    aiguang@hotmail.com   
Sponsors and Collaborators
Shanghai University of Traditional Chinese Medicine
Shanghai Zhongshan Hospital
RenJi Hospital
Fudan University
ShuGuang Hospital
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Ruijin Hospital
Yunnan Provinical Hospital of Traditional Chinese Medicine
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Shaanxi Hospital of Traditional Chinese Medicine
Investigators
Principal Investigator: zhao ai guang, Dr. Shanghai Longhua Hospital
  More Information

Publications:
Responsible Party: Shanghai University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT02781285     History of Changes
Other Study ID Numbers: LONGHUA-2016-SH
First Submitted: May 15, 2016
First Posted: May 24, 2016
Last Update Posted: October 12, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Additional relevant MeSH terms:
Adenocarcinoma
Stomach Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases