General Tissue Response Classification System After Chemotherapy
The Establishment of General Tissue Response Classification System After Chemotherapy According to Gastric Cancer Patients With Neoadjuvant Chemotherapy
1 other identifier
observational
200
1 country
1
Brief Summary
This research intend to collect the information of gastric cancer patients who received preoperative neoadjuvant chemotherapy and radical gastric ectomy at Department of Gastrointestinal Surgery, West China Hospital, Sichuan University. Base on The degree of edema, intraoperative effusion, fibrosis of connecting tissues, the investigators aim to constitute the core parameters of the tissue response grading system following neoadjuvant chemotherapy, and explore the mutual effect among the tissue response grading system, tumor regression response and long-term survival outcome of tumor patients.
Trial Health
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participants targeted
Target at P75+ for all trials
Started Jan 2019
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 25, 2018
CompletedStudy Start
First participant enrolled
January 1, 2019
CompletedFirst Posted
Study publicly available on registry
January 2, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedJanuary 2, 2019
December 1, 2018
2 years
December 25, 2018
December 31, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
General observation of tissue fibrosis, edema and exudation (Intraoperation)
To assess the degree of fibrosis, edema and exudation in tumor tissue and main perigastric lymph node area during the operation.
The 1 day of surgery
Secondary Outcomes (6)
General observation of tissue edema (Intraoperation)
The 1 day of surgery
General observation of tissue exudation (Intraoperation)
The 1 day of surgery
Histopathology evaluation of edema
The 1 day of surgery
Histopathology evaluation of tissue fibrosis
Postoperative 30 days
Postoperative mortality rate
Postoperative 30 days
- +1 more secondary outcomes
Study Arms (1)
Group A
Gastric Cancer Patients who underwent Chemotherapy and will have gastric cancer surgery.
Interventions
Gastric cancer surgery is performed according to the Japanese Guidelines. Patients will intraoperative evaluate the edema, fibrosis and exudation.
Eligibility Criteria
Gastric cancer patients who received preoperative neoadjuvant chemotherapy and radical gastric ectomy at Department of Gastrointestinal Surgery, West China Hospital, Sichuan University
You may qualify if:
- The diagnosis of gastric cancer was clear，Patients with definitely clinical evidence of locally advanced disease (cT3 ⁄ 4、N-/+、M0).
- Preoperative chemotherapy has been administered，and intended to receive surgical resection.
- Age:less than or equal to 75 years old and more than 18 years old;
- Without any other malignant tumor, without any serious concomitant disease.
- Eastern Cooperative Oncology Group (ECOG) physical status score \<2, America Society of Anesthesiologist (ASA) score\<3
- No restriction on gender or race; Informed consent has been signed by patient or entrusted agent；
You may not qualify if:
- Previous history of gastric ulcer or gastric perforation;
- Previous operation history at upper abdominal, except laparoscopic cholecystectomy;
- Emergency operation caused by obstruction, perforation,and acute hemorrhage;
- The patient can not tolerate the surgical treatment which caused by other serious concomitant disease, such as severe pulmonary disease, cardiac clinical function below are below level 2, pulmonary infection, moderate or severe chronic obstructive pulmonary disease (COPD), chronic bronchitis
- Patient has severe mental illness
- The patient and agent request to withdraw from the clinical study after signing the consent form.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041, China
Related Publications (1)
Yang H, Zhang WH, Ge R, Peng BQ, Chen XZ, Yang K, Liu K, Chen XL, He D, Liu JP, Zhang WW, Qin Y, Zhou ZG, Hu JK. Application of Gross Tissue Response System in Gastric Cancer After Neoadjuvant Chemotherapy: A Primary Report of a Prospective Cohort Study. Front Oncol. 2021 Nov 24;11:585006. doi: 10.3389/fonc.2021.585006. eCollection 2021.
PMID: 34900661DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Jian-Kun Hu, MD, PhD
West China Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Vice director of Gastrointestinal Surgery department, West China Hospital; Director of Institute of Gastric Cancer, State Key Laboratory of Biotherapy, West China Hospital
Study Record Dates
First Submitted
December 25, 2018
First Posted
January 2, 2019
Study Start
January 1, 2019
Primary Completion
December 31, 2020
Study Completion
December 31, 2020
Last Updated
January 2, 2019
Record last verified: 2018-12