Gastric CancerNCT04440605
A Study to Confirm the Accuracy of Locally Advanced Gastric Cancer Diagnosis
An observational study of Gastric Cancer and Gastric Cancer Stage, run by Peking University at 38 sites in China.
Trial summary
With the introducing of neoadjuvant therapy, it becomes ever more important to evaluate the preoperative TNM (cTNM) stage accurately facilitating preoperative treatment as well as the adjuvant therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer, Gastric Cancer Stage, CT
- What is being tested?
- Preoperative staging--D2 gastrectomy--Postoperative staging
- Type of treatment
- Surgery or procedure
- How many people
- 968 participants
- Where
- 38 sitesChina
- Study dates
- 1 Jul 2020to Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with endoscopically biopsy-proven adenocarcinoma of the stomach and with contrast-enhanced CT cI-III diagnosis prior to surgery will receive treatment.
Who may be able to join
- Histological prove of adenocarcinoma of the stomach by endoscopy
- Preoperative imaging data by contrast-enhanced CT and clinical TNM stages were given
- No evidence of stage IV disease
- No previous gastrectomy or preoperative treatment.
Who cannot join
- Discovery of distant metastasis (stage IV) during surgery
- Number of retrieved lymph node less than 15
Trial locations and contacts
38 sites in 1 country.
38 sites in 1 country
China38 sites, 38 recruiting
- Recruiting
Peking University Cancer Hospital & Institute
Beijing, Beijing Municipality, 100142
Ziyu Li, M.D., 86-010-8819-6606, ziyu_li@hsc.pku.edu.cn
Ziyu Li, M.D., Ph.D, 86-010-8819-6605, ziyu_li@hsc.pku.edu.cn
- Not yet recruiting
301 Hospital
Beijing, Beijing Municipality
Xiaohui Du, M.D.
- Not yet recruiting
302 Military Hospital of China
Beijing, Beijing Municipality
Feng Liang, M.D.
- Not yet recruiting
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality
Jun Zhang, M.D.
- Not yet recruiting
Beijing Hospital
Beijing, Beijing Municipality
Gang Zhao, M.D.
- Not yet recruiting
Peking University International Hospital
Beijing, Beijing Municipality
Ning Ning, M.D.
- Not yet recruiting
Peking University Peoples Hospital
Beijing, Beijing Municipality
Bin Liang, M.D.
- Not yet recruiting
The First Hospital of Jilin University
Changchun, Jilin
Daguang Wang, M.D.
- Not yet recruiting
The Second Hospital of Jilin University
Changchun, Jilin
Jiaming Zhu, M.D.
- Not yet recruiting
West China Hospital
Chengdu, Sichuan
Kun Yang, M.D.
- Not yet recruiting
The Second Affiliated Hospital-Dalian Medical University
Dalian, Liaoning
Xinsheng Zhang, M.D.
- Not yet recruiting
Fujian Medical University Union Hospital
Fuzhou, Fujian
Zhaohui Zheng, M.D.
- Not yet recruiting
Fujian Tumor Hospital
Fuzhou, Fujian
Weidong Zang, M.D.
- Not yet recruiting
Guangdong General Hospital
Guangzhou, Guangdong
Yong Li, M.D.
- Not yet recruiting
Guangdong Hospital of Traditional Chinese Medicine
Guangzhou, Guangdong
Wei Wang, M.D.
- Not yet recruiting
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong
Jiang Yu, M.D.
- Not yet recruiting
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong
Wu Song, M.D.
- Not yet recruiting
Heilongjiang Cancer Hospital
Harbin, Heilongjiang
Kuan Wang, M.D.
- Not yet recruiting
Shandong Provincial Hospital
Jinan, Shandong
Changqing Jing, M.D.
- Not yet recruiting
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi
Zhengrong Li, M.D.
- Not yet recruiting
Jiangsu People's Hospital
Nanjing, Jiangsu
Zekuan Xu, M.D.
- Not yet recruiting
Qingdao Municipal Hospital
Qingdao, Shandong
Hong Qi, M.D.
- Not yet recruiting
The Affiliated Hospital of Qingdao University
Qingdao, Shandong
Zhaojian Niu, M.D.
- Not yet recruiting
Fudan University Cancer center
Shanghai, Shanghai Municipality
Hua Huang, M.D.
- Not yet recruiting
Ruijin Hospital
Shanghai, Shanghai Municipality
Lu Zang, M.D.
- Not yet recruiting
Shanghai Renji Hospital
Shanghai, Shanghai Municipality
Gang Zhao, M.D.
- Not yet recruiting
Zhongshan Hospital
Shanghai, Shanghai Municipality
Fenglin Liu, M.D.
- Not yet recruiting
Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei
Qun Zhao, M.D.
- Not yet recruiting
Shanxi Tumour Hospital
Taiyuan, Shanxi
Qingxing Huang, M.D.
- Not yet recruiting
Tianjin Medical University Cancer Hospital
Tianjin, Tianjin Municipality
Jingyu Deng, M.D.
- Not yet recruiting
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality
Weihua Fu, M.D.
- Not yet recruiting
First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang
Wenbin Zhang, M.D.
- Not yet recruiting
Weifang People's Hospital
Weifang, Shandong
Jianjun Qu, M.D.
- Not yet recruiting
Wuhan Union Hospital
Wuhan, Hubei
Kaixiong Tao, M.D.
- Not yet recruiting
First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi
Lin Fan, M.D.
- Not yet recruiting
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian
Jun You, M.D.
- Not yet recruiting
Zhongshan Hospital of Xiamen University
Xiamen, Fujian
Xingfeng Qiu, M.D.
- Not yet recruiting
Qinghai University Affiliated Hospital
Xining, Qinghai
Su Yan, M.D.
About this study
Official title: A Study to Confirm the Accuracy of Locally Advanced Gastric Cancer Diagnosis: A Prospective, Multicenter, Cohort Study
With the introducing of neoadjuvant therapy, it becomes ever more important to evaluate the preoperative TNM (cTNM) stage accurately facilitating preoperative treatment as well as the adjuvant therapy.
At present, the recommendation of neoadjuvant chemotherapy varies among guidelines especially between eastern and western countries. According to the updated Japanese gastric cancer treatment guidelines (ver.5), neoadjuvant chemotherapy is the recommended standard procedure for patients with cT2-4 stages. However, the acknowledgement of preoperative therapy accompanied by the higher risk of overtreatment. As mentioned in JCOG1302-A, the overall precision rate in cT staging is 38.8%. Patients diagnosed with pI stages postoperatively account for 6.5% in cT3-4N+ treatment indicating more likely to avoiding the overtreatment comparing to patients with other cT stages.
Inspired by JCOG1302-A, this multicentre study prospectively collect data in preoperative TNM staging assessment using CT(computed tomography, CT) scan and the postoperative TNM (pTNM) staging according to histopathologically examination. By analyzing the accordance between the cTNM and pTNM, this study aims to evaluate the current accuracy of the cTNM staging in china, verifying the proportion of pI stages less than 5% in cIII stage diagnosis patients, learning the overtreating rate in neoadjuvant chemotherapy in China and furthermore, to discover the scope of beneficiaries for neoadjuvant chemotherapy.
Read the detailed description
OBJECTIVES:
- Confirm the inclusion of pathological stage I (pI) among clinical stage III(T3-4aNx) (cIII) diagnosis patients less than 5% II. Figure out the suitable criterion of NAC and avoid overtreatment, by examining the rate of pI rate in different diagnostic criterion groups, including cIII, TxNy(x+y>4), cN1-3, cT3-4.
III. Evaluate the current state of diagnostic accuracy of preoperative CT staging in china.
OUTLINE:
This is a prospective, multi-centers, cohort study of clinical TNM staging diagnostic accuracy.
Patients are divided into 3 preoperative stage groups according to AJCC 8th edition (cI, cII, cIII) preoperatively. All patients receive the D2 gastrectomy after cTNM diagnosis and the pathological stages is given following surgery.
The concordance of preoperative staging is evaluated in each cohorts as well as the subgroups to obtain the accuracy rate. The pI proportion will calculate in each latent criterion groups to assess the suitable NAC criteria.
PROJECTED ACCRUAL: A total of 968 patients will be accrued for this study within two years.
- Conditions
- Gastric Cancer, Gastric Cancer Stage, CT, Neoadjuvant Therapy
- Being tested
- Preoperative staging--D2 gastrectomy--Postoperative staging
- Keywords
- Gastric cancer, Clinical TNM staging, Adenocarcinoma
- Medical subject headings
- Stomach Neoplasms, Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative staging--D2 gastrectomy--Postoperative stagingProcedure or surgery
Preoperative TNM staging under CT scan plus endoscopy endoscopic biopsy, and postoperative staging after D2 gastrectomy
| Study group | Role | What they receive |
|---|---|---|
| cI | clincal TNM stage I Receives: Procedure: Preoperative staging--D2 gastrectomy--Postoperative staging | |
| cII | clinical TNM stage II Receives: Procedure: Preoperative staging--D2 gastrectomy--Postoperative staging | |
| cIII | clinical TNM stage III Receives: Procedure: Preoperative staging--D2 gastrectomy--Postoperative staging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Accuracy of cIII
Proportion of pathological stage I among clinical stage III(T3-4aNx) diagnosis patients
Measured: 1.5 years
Secondary outcomes (4)
Diagnostic Accuracy of cTxNy
Proportion of pathological stage I among clinical TxNy(x+y>4) stage diagnosis patients
Measured: 1.5 years
Diagnostic Accuracy of cN+
Proportion of pathological stage I among clinical N1-3 stage diagnosis patients
Measured: 1.5 years
Diagnostic Accuracy of cT3/4
Proportion of pathological stage I among clinical T3-4 stage diagnosis patients
Measured: 1.5 years
Diagnostic Accuracy of cTN
The concordance rate for clinical staging
Measured: 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2020
- Study start1 Jul 2020 (estimated)
- Primary completionApr 2022 (estimated)
- Study completionOct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Peking UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 968 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Collaborators
- RenJi Hospital, Ruijin Hospital, West China Hospital, Beijing 302 Hospital, Fudan University, Peking University International Hospital, Guangdong Provincial Hospital of Traditional Chinese Medicine, Fujian Medical University Union Hospital, First Affiliated Hospital Xi'an Jiaotong University, Chinese PLA General Hospital, First Affiliated Hospital of Xinjiang Medical University, Tianjin Medical University General Hospital, The Second Affiliated Hospital of Dalian Medical University, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Peking University People's Hospital, Weifang People's Hospital, Second Hospital of Jilin University, Fujian Province Tumor Hospital, Shanxi Province Cancer Hospital, The First Affiliated Hospital of Nanchang University, Tianjin Medical University Cancer Institute and Hospital, Shanghai Zhongshan Hospital, First Affiliated Hospital, Sun Yat-Sen University, The Affiliated Hospital of Qingdao University, The First Affiliated Hospital of Xiamen University, Beijing Hospital, Beijing Friendship Hospital, Qingdao Municipal Hospital, Guangdong Provincial People's Hospital, Affiliated Hospital of Qinghai University, Shandong Provincial Hospital, The First Hospital of Jilin University, Nanfang Hospital, Southern Medical University, Zhongshan Hospital Xiamen University, Hebei Medical University Fourth Hospital
- Responsible party
- Principal investigator, Ziyu Li, MD, Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04440605
- Sponsor's protocol ID
- 2019YJZ55
- Status last verified
- Jun 2020
- First submitted
- 17 Jun 2020
- Last updated
- 19 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fukagawa T, Katai H, Mizusawa J, Nakamura K, Sano T, Terashima M, Ito S, Yoshikawa T, Fukushima N, Kawachi Y, Kinoshita T, Kimura Y, Yabusaki H, Nishida Y, Iwasaki Y, Lee SW, Yasuda T, Sasako M; Stomach Cancer Study Group of the Japan Clinical Oncology Group. A prospective multi-institutional validity study to evaluate the accuracy of clinical diagnosis of pathological stage III gastric cancer (JCOG1302A). Gastric Cancer. 2018 Jan;21(1):68-73. doi: 10.1007/s10120-017-0701-1. Epub 2017 Feb 13.
PubMed 28194522
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Confirm the Accuracy of Locally Advanced Gastric Cancer Diagnosis: A Prospective, Multicenter, Cohort Study
- ClinicalTrials.gov ID
- NCT04440605
- Acronym / sponsor ID
- 2019YJZ55
- Conditions
- Gastric Cancer, Gastric Cancer Stage, CT, Neoadjuvant Therapy
- Keywords
- Gastric cancer, Clinical TNM staging, Adenocarcinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 968 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Collaborators
- RenJi Hospital, Ruijin Hospital, West China Hospital, Beijing 302 Hospital, Fudan University, Peking University International Hospital, Guangdong Provincial Hospital of Traditional Chinese Medicine, Fujian Medical University Union Hospital, First Affiliated Hospital Xi'an Jiaotong University, Chinese PLA General Hospital, First Affiliated Hospital of Xinjiang Medical University, Tianjin Medical University General Hospital, The Second Affiliated Hospital of Dalian Medical University, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Peking University People's Hospital, Weifang People's Hospital, Second Hospital of Jilin University, Fujian Province Tumor Hospital, Shanxi Province Cancer Hospital, The First Affiliated Hospital of Nanchang University, Tianjin Medical University Cancer Institute and Hospital, Shanghai Zhongshan Hospital, First Affiliated Hospital, Sun Yat-Sen University, The Affiliated Hospital of Qingdao University, The First Affiliated Hospital of Xiamen University, Beijing Hospital, Beijing Friendship Hospital, Qingdao Municipal Hospital, Guangdong Provincial People's Hospital, Affiliated Hospital of Qinghai University, Shandong Provincial Hospital, The First Hospital of Jilin University, Nanfang Hospital, Southern Medical University, Zhongshan Hospital Xiamen University, Hebei Medical University Fourth Hospital
- Study start
- 1 Jul 2020 (estimated)
- Primary completion
- Apr 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 19 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
With the introducing of neoadjuvant therapy, it becomes ever more important to evaluate the preoperative TNM (cTNM) stage accurately facilitating preoperative treatment as well as the adjuvant therapy.
At present, the recommendation of neoadjuvant chemotherapy varies among guidelines especially between eastern and western countries. According to the updated Japanese gastric cancer treatment guidelines (ver.5), neoadjuvant chemotherapy is the recommended standard procedure for patients with cT2-4 stages. However, the acknowledgement of preoperative therapy accompanied by the higher risk of overtreatment. As mentioned in JCOG1302-A, the overall precision rate in cT staging is 38.8%. Patients diagnosed with pI stages postoperatively account for 6.5% in cT3-4N+ treatment indicating more likely to avoiding the overtreatment comparing to patients with other cT stages.
Inspired by JCOG1302-A, this multicentre study prospectively collect data in preoperative TNM staging assessment using CT(computed tomography, CT) scan and the postoperative TNM (pTNM) staging according to histopathologically examination. By analyzing the accordance between the cTNM and pTNM, this study aims to evaluate the current accuracy of the cTNM staging in china, verifying the proportion of pI stages less than 5% in cIII stage diagnosis patients, learning the overtreating rate in neoadjuvant chemotherapy in China and furthermore, to discover the scope of beneficiaries for neoadjuvant chemotherapy.
Detailed description
OBJECTIVES:
- Confirm the inclusion of pathological stage I (pI) among clinical stage III(T3-4aNx) (cIII) diagnosis patients less than 5% II. Figure out the suitable criterion of NAC and avoid overtreatment, by examining the rate of pI rate in different diagnostic criterion groups, including cIII, TxNy(x+y>4), cN1-3, cT3-4.
III. Evaluate the current state of diagnostic accuracy of preoperative CT staging in china.
OUTLINE:
This is a prospective, multi-centers, cohort study of clinical TNM staging diagnostic accuracy.
Patients are divided into 3 preoperative stage groups according to AJCC 8th edition (cI, cII, cIII) preoperatively. All patients receive the D2 gastrectomy after cTNM diagnosis and the pathological stages is given following surgery.
The concordance of preoperative staging is evaluated in each cohorts as well as the subgroups to obtain the accuracy rate. The pI proportion will calculate in each latent criterion groups to assess the suitable NAC criteria.
PROJECTED ACCRUAL: A total of 968 patients will be accrued for this study within two years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| cI | – | Procedure: Preoperative staging--D2 gastrectomy--Postoperative stagingclincal TNM stage I |
| cII | – | Procedure: Preoperative staging--D2 gastrectomy--Postoperative stagingclinical TNM stage II |
| cIII | – | Procedure: Preoperative staging--D2 gastrectomy--Postoperative stagingclinical TNM stage III |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with endoscopically biopsy-proven adenocarcinoma of the stomach and with contrast-enhanced CT cI-III diagnosis prior to surgery will receive treatment.
Key inclusion criteria (4 listed)
- Histological prove of adenocarcinoma of the stomach by endoscopy
- Preoperative imaging data by contrast-enhanced CT and clinical TNM stages were given
- No evidence of stage IV disease
- No previous gastrectomy or preoperative treatment.
Key exclusion criteria (2 listed)
- Discovery of distant metastasis (stage IV) during surgery
- Number of retrieved lymph node less than 15
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preoperative staging--D2 gastrectomy--Postoperative stagingPreoperative TNM staging under CT scan plus endoscopy endoscopic biopsy, and postoperative staging after D2 gastrectomy | Procedure or surgery | cI, cII, cIII |
Primary outcome
Diagnostic Accuracy of cIII
Time frame: 1.5 years
Proportion of pathological stage I among clinical stage III(T3-4aNx) diagnosis patients
4 secondary outcomes
Diagnostic Accuracy of cTxNy
Time frame: 1.5 years
Diagnostic Accuracy of cN+
Time frame: 1.5 years
Diagnostic Accuracy of cT3/4
Time frame: 1.5 years
Diagnostic Accuracy of cTN
Time frame: 1.5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2020.
- Background: PubMed 28194522Fukagawa T, Katai H, Mizusawa J, Nakamura K, Sano T, Terashima M, Ito S, Yoshikawa T, Fukushima N, Kawachi Y, Kinoshita T, Kimura Y, Yabusaki H, Nishida Y, Iwasaki Y, Lee SW, Yasuda T, Sasako M; Stomach Cancer Study Group of the Japan Clinical Oncology Group. A prospective multi-institutional validity study to evaluate the accuracy of clinical diagnosis of pathological stage III gastric cancer (JCOG1302A). Gastric Cancer. 2018 Jan;21(1):68-73. doi: 10.1007/s10120-017-0701-1. Epub 2017 Feb 13.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
38 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Cancer and Gastric Cancer Stage, run by Peking University at 38 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Accuracy of cIII (time frame: 1.5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04440605, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2020.