Neoplasms

All Conditions

Digestive System Diseases

Rare Diseases

Adenocarcinoma

Stomach Neoplasms

Carcinoma in Situ

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Stomach Cancer

Individuals with a pathologically confirmed diagnosis of gastric cancer

Individuals without cancer at the time of blood sampling

A panel of microRNA, whose expression level is tested in serum samples.

DESTINEX

Ajay Goel, PhD

Silei Sui

Caiming Xu

Yasuhiro Kodera

Mitsuo Kanda

Yuji Toiyama

Yoshinaga Okugawa

Gastric cancer continues to have a poor prognosis primarily due to the inability to detect it in its early stages. This study will develop and validate a blood assay to facilitate the non-invasive detection of gastric cancer.

Gastric cancer continues to have a poor prognosis primarily due to the inability to detect it in its early stages. Because conventional endoscopy is invasive and costly, gastric cancer is currently not considered to be screenable at a population level. However, if one could find less invasive and cheaper tools that accurately detect gastric cancer in its early stages, it could make a significant difference. Accurate biomarkers could help identify patients with gastric cancer before it becomes incurable.

This study aims to develop a non-invasive test to detect gastric cancer early. It consists of four phases:

1. Discovering potential biomarkers with a comprehensive and genome-wide transcriptomic sequencing analysis that will involve gastric cancer tissue, normal tissue, and serum samples from patients with gastric cancer, as well as samples from people without the disease.
2. Using machine learning to develop a combination "signature" of cell-free (cf) and exosomal (exo)-miRNA in serum specimens from a training cohort.
3. A validation of this signature in an independent cohort to confirm its accuracy.
4. An evaluation of the temporal trend of this signature in paired samples collected pre-surgery and post-surgery to investigate their potential and specificity as indicators of minimal residual disease.

In summary, this study aims to develop a highly accurate and cost-effective blood test for detecting gastric cancer early. Success could lead to significant improvements in clinical practice by catching cancer when it is most treatable. By combining different genetic markers (cell-free microRNA and exosomal microRNA) for accuracy, this study has the potential to reduce gastric cancer deaths and could lead to new screening methods in the future.

Formalin-fixed and paraffin-embedded tissue samples Serum

Stomach Cancer Exosome-based Detection

Early Detection of Stomach Cancer With a Liquid Biopsy Based on Exosomal Micro-RNA

Data collected for the study will be made available to others, including de-identified participant data, at publication, via a signed data access agreement and at the discretion of the investigators' approval of the proposed use of such data

True positive rate: the probability of a positive test result, conditioned on the individual truly being positive

True negative rate: the probability of a negative test result, conditioned on the individual truly being negative

A measure of trueness: proportion of correct predictions (both true positives and true negatives) among the total number of cases examined

City of Hope Medical Center

Preoperative TNM staging under CT scan plus endoscopy endoscopic biopsy, and postoperative staging after D2 gastrectomy

Preoperative staging--D2 gastrectomy--Postoperative staging

Ziyu Li, M.D.

Ziyu Li, M.D., Ph.D

Jiafu Ji, M.D.

Fei Shan, M.D.

Xiangji Ying, M.P.H

Chao Gao, M.D.

Xiaohui Du, M.D.

Feng Liang, M.D.

Jun Zhang, M.D.

Gang Zhao, M.D.

Ning Ning, M.D.

Bin Liang, M.D.

Zhaohui Zheng, M.D.

Weidong Zang, M.D.

Jun You, M.D.

Xingfeng Qiu, M.D.

Yong Li, M.D.

Wei Wang, M.D.

Jiang Yu, M.D.

Wu Song, M.D.

Qun Zhao, M.D.

Kuan Wang, M.D.

Kaixiong Tao, M.D.

Zekuan Xu, M.D.

Zhengrong Li, M.D.

Daguang Wang, M.D.

Jiaming Zhu, M.D.

Xinsheng Zhang, M.D.

Su Yan, M.D.

Lin Fan, M.D.

Changqing Jing, M.D.

Hong Qi, M.D.

Zhaojian Niu, M.D.

Jianjun Qu, M.D.

Hua Huang, M.D.

Lu Zang, M.D.

Fenglin Liu, M.D.

Qingxing Huang, M.D.

Kun Yang, M.D.

Jingyu Deng, M.D.

Weihua Fu, M.D.

Wenbin Zhang, M.D.

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.

OBJECTIVES:

I. 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.

Adenocarcinoma tissue sample retrieved by endoscopic and sugical methods

A Study to Confirm the Accuracy of Locally Advanced Gastric Cancer Diagnosis

A Study to Confirm the Accuracy of Locally Advanced Gastric Cancer Diagnosis: A Prospective, Multicenter, Cohort Study

Proportion of pathological stage I among clinical stage III(T3-4aNx) diagnosis patients

Proportion of pathological stage I among clinical TxNy(x+y\>4) stage diagnosis patients

Proportion of pathological stage I among clinical N1-3 stage diagnosis patients

Proportion of pathological stage I among clinical T3-4 stage diagnosis patients

The concordance rate for clinical staging

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

Wuhan Union Hospital, China

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

Peking University

M.D., Ph.D.

All patients will be treated according to standard practice. Patients in group I are patients that will be stratified for radical gastrectomy or endoscopic resection. Group I will undergo only a primary staging. All patients will take DECT and mpMRI examination within 1 week before surgery.

Patients in group II are patients that will be stratified for neoadjuvant chemotherapy.

Group II will undergo a primary staging (DECT and mpMRI) and 1-2 times restaging (DECT and mpMRI).

DECT examinations will be performed using a 192-slice CT scanner (SOMATOM, Force, Siemens, Forchheim, Germany).

DECT examination

The examinations were conducted on a 3-T MR scanner (MAGNETOM Skyra; Siemens Healthcare, Erlangen, Germany).

mpMRI examination

Yu-Dong Zhang, MD;PHD

Accurate preoperative staging of gastric cancer is of major importance for guiding therapeutic decision-making, preventing both under- and over-treatment. The purpose of this study is to investigate the diagnostic performance of the Multi-parametric magnetic resonance imaging (mpMRI) and dual-energy computed tomography (DECT) in gastric cancer.

Gastric cancer is the leading cause of cancer-related death worldwide. The therapeutic approach to gastric cancer is strongly dependent on preoperative stage. The crucial role of gastric cancer imaging lies in implementing individualized treatment regimens according to various stages of tumor.

CT scanning has been recommended as the first-line image modality for preoperative evaluation of gastric cancer by the 8th AJCC staging manual. However, for traditional CT, the accuracy of staging is highly variable and the sensitivity of early gastric cancer detection is relatively low. Recently, DECT has been increasingly used in clinical practice due to its powerful post-processing technique. A recent small sample study showed that monoenergetic images at 40 KeV improved lesion depiction and higher T stage accuracy for gastric cancer. Therefore, this study chose DECT instead of traditional CT to explore the diagnostic performance in preoperative staging.

Historically, the role of MRI in gastric cancer has been limited, and the guidelines have not yet recommended MRI as a first-line examination scheme. But with the continuous technical improvements for abdominal imaging (e.g. breath-hold sequences and high Resolution diffusion-weighted imaging (DWI), free-breathing dynamic contrast-enhanced (DCE) sequence), mpMRI has become a promising imaging technology. In addition, given the advantages of non-radiation, non-invasiveness, and excellent soft tissue contrast, mpMRI may be more suitable for neoadjuvant therapy patients who require multiple evaluations.

Patients with gastric cancer confirmed by endoscopic biopsy will be prospectively included in this study. Patients undergo both mpMRI and DECT at baseline to stage the primary tumor, regional lymph nodes, and to rule out distant sites of disease. The interval between mpMRI and DECT examinations should not exceed 7 days. All patients will be treated according to standard practice in our institution. Patients receiving neoadjuvant chemotherapy will undergo mpMRI and DECT scan again for restaging. The postoperative pathology results of these two examination methods were prospectively collected, and their efficacy was calculated according to the reference standard. After completion of study intervention, patients are followed up periodically.

Multi-parametric MRI and Dual-energy CT in Patients of Gastric Cancer

Diagnostic Accuracy of Multi-parametric MRI and Dual-energy CT in Gastric Cancer: a Paired Validating Confirmatory Study

Accuracy for both imaging techniques in the prediction of tumor staging.

Accuracy for both imaging techniques in the prediction of tumor restaging.

Inter-rater reliability of the DECT and mpMRI in tumor assessment

Pathological tumour regression grading (Mandard criterion): from 1 to 5 grading.

Survival analysis: Radiologic data predicting DFS.

Survival analysis: Radiologic data predicting OS.

Qualitative image analysis of mpMRI in a supine and prone position

Quantitative image analysis of mpMRI in a supine and prone position.

The First Affiliated Hospital with Nanjing Medical University

No intervention

Jinrong Qu

Jing Ding, Master

Baoxia He, MD

It is very significant that assessing staging in gastric cancer patients before surgery, furthermore, determining the optimize surgical strategy ,predict the the efficacy of neoadjuvant therapy for patients. For patients who are ineffective in neoadjuvant therapy, surgery will be more meaningful.

It has been reported that the application of CT(computed tomography,CT) and MR(magnetic resonance,MR) in staging of gastric cancer, but not in predicting clinical response to neoadjuvant therapy for gastric cancer. Only a few studies focused on T staging using conventional MRI in gastric cancer, however , relatively new sequences in the chest deserve widely used. To develop a pre-treatment evaluation methods for TN staging in patient with gastric cancer by utilization of the new imaging methods (T2-TSE-BLADE,T2 maps, StarVIBE, iShim-DWI and high resolution CT). By analysing the relationship between TN staging and imaging features to find the imaging characteristics for TN staging, and to find the indicators of new technology and reference values for facilitate pre-treatment diagnosis of TN staging, optimize surgical strategy , predict the the efficacy of adjunctive therapy , and OS and define the range of lymph node for radiotherapy , as making personal treatment planning for gastric cancer .

To explore the value of CT and MR using multiple sequences, including T2-TSE-BLADE, T2 maps StarVIBE, and iShim-DWI in evaluating the preoperative TN staging and prediction of response to neoadjuvant therapy and OS in patients with gastric cancer.

Patients with endoscopically biopsy-proven gastric cancer were prospectively enrolled for imaging on CT and a 3T MRI scanner . The MRI protocol included T2-TSE-BLADE, T2 maps,iShim-DWI(diffusion weighted imaging,DWI)and StarVIBE sequences, and so on. Patients received treatment according to NCCN guideline(the National Comprehensive Cancer Network,NCCN). Readers assigned a TN stage on CT and MRI, and post-operative pathologic confirmation was considered the gold standard.

Inter-reader agreement, the diagnostic accuracy of TN staging on CT and MRI were analyzed and compared to post-operative pathologic TN staging separately. MRI features were analyzed to find the correlation between pretreatment MRI features and response or OS. The study will include 400 patients. Inter-reader agreements of TN staging were analyzed excellent for CT and MRI. Diagnostic accuracy of CT and MRI will be calculated separately.

Study of CT and MR in the Gastric Cancer

Clinical Study of CT and MR in Staging and Prediction of Response in Patients With Gastric Cancer

To evaluate the staging of gastric cancer treated with systematic therapy through MSCT and 3 T MRI which using multiple sequences.

To construct a model,a depth convolution neural network based on MSCTand multi-modal MR quantitative images which can automatically mine key images characterization, combined with imaging features and prognosis,could further help to improve the prediction of response and OS of gastric cancer treated with systematic therapy.

Henan Cancer Hospital

Symptoms and General Pathology

Neoplasm Metastasis

Lymphatic Metastasis

Neoplastic Processes

gastric cancer patients with no lymph node metastasis

gastric cancer patients with lymph node metastasis, including patients with N1, N2 and N3 stage cancer

We retrospectively evaluated the relationship between lymph node metastasis and coagulation-related factors in 516 patients with T4a stage gastric cancer.

coagulation-related factors

Feng Tian, Doctor

Changqing Jing, Doctor

We initially selected a total of 1128 patients with primary gastric cancer who presented at Shandong Provincial Hospital between January 2018 and October 2022, and retrospectively collected their clinical and pathological data. And retrospectively analyzed preoperative baseline characteristics, preoperative laboratory tests, and postoperative pathological results for these patients

Association Between Multiple Coagulation-related Factors and Lymph Node Metastasis in Patients With Gastric Cancer: A Retrospective Cohort Study

After the article is published, the original data can be obtained by contacting the project leader.

MA values(mm). Measure the data of preoperative MA values in 516 gastric cancer patients to see wether this indicator correlated with tumor stage in patients with gastric cancer.

Platelet counts（x10\^9/L). Measure the data of preoperative platelet counts in 516 gastric cancer patients to see wether this indicator correlated with tumor stage in patients with gastric cancer.

Fibrinogen levels (g/L). Measure the data of preoperative fibrinogen levels in 516 gastric cancer patients to see wether this indicator correlated with tumor stage in patients with gastric cancer.

D-dimer (mg/L). Measure the data of preoperative D-dimer in 516 gastric cancer patients to see wether this indicator correlated with tumor stage in patients with gastric cancer.

Recording the postoperative pathological tumor T stage in 516 patients with gastric cancer.

Recording the postoperative pathological tumor N stage in 516 patients with gastric cancer.

Director

Total gastrectomy with concentional D2 lymphadenectomy

More extended resection type with better oncological outcomes when compared to standard technique

Total mesogastrectomy

Objective: To define complete mesogastric excision and compare our short term results for the first time in a different population.

Study design:Randomised-controlled study

Place and duration of the study: Gastroenterological Surgery Clinic,Health Sciences University,Basaksehir City Hospital,Istanbul,Turkey,from April to December 2023.

Methodology: We compared short term results of open total gastrectomy+ mesogastrectomy with standard total gastrectomy + D2 lymph node dissection at a tertiary center in terms of peroperative results, histopathological findings and postoperative short- term outcomes with review of the literature.

Conclusion: Our aim is to show that mesogastric excision is safe and has advantages over conventional D2 gastrectomy in means of not only peroperative and short-term outcomes, but also disease free survival.Our work is the first study from a different population of the world and our initial results can contribute to the literature for universalization.

The curative treatment of gastrointestinal tumors is surgery referring to an en block resection of the primary tumor along with its lymphovascular drainage.Unfortunately, despite of these radical resections, published literature shows that recurrences occur in up to 38% of patients in 5 years. Morover, these rates may reach to 60% in patients with locally advanced tumor following radical surgery. However, this mesentery-based surgery is harder to apply in gastric cancer due to differences in embriyological development. In our prospective study and a review of the literature, following the descripiton of mesogastrium concept, we aimed to search and analyse former techniques and viewpoints about mesogastric excision by different surgical approaches from various countries. Later, we aimed to show our technique of mesogastrectomy, compared our short term results with limited publications from the literature.

Study group participants: total gastrectomy+mesogastrectomy Control group: Standard total gastrectomy + D2 lymph node dissection

Complete Mesogastric Excision With D2 Lympadenectomy for Gastric Cancer:

Short-term Results of a Randomized Controlled Trial and Review of the Literature Complete Mesogastric Excision With D2 Lympadenectomy for Gastric Cancer: Short-term Results of a Randomized Controlled Trial and Review of the Literature

Başakşehir Çam & Sakura City Hospital

Michael B Gill

This study is observational, meaning that it does not include any interventions or new treatments. As a result, there may not be an immediate benefit for the patient with gastric cancer.

However, the data collected from this trial can contribute to a better understanding of the factors that affect withdrawal and enrolment rates in gastric cancer clinical trials, and may ultimately lead to improved patient outcomes in the future.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Stomach Cancer Exosome-based Detection	NCT06342427	Gastric Cancer Gastric Adenoca... Gastric Cancer ... Gastric Neoplas... Gastric Lesion Gastric Cancer ... Gastric Cancer ... Gastric Cancer ... Gastric Cancer ... Gastric Cancer ... Gastric Cancer ... Gastric Cancer,... Gastric Cancer ... Gastric Cancer ... Gastric Cancer ... Gastric Cancer ... Gastric Cancer ... Gastric Cancer ... Gastric Cancer ...	DESTINEX	18 Years -	City of Hope Medical Center
A Study to Confirm the Accuracy of Locally Advanced Gastric Cancer Diagnosis	NCT04440605	Gastric Cancer Gastric Cancer ... CT Neoadjuvant The...	Preoperative st...	18 Years -	Peking University
Multi-parametric MRI and Dual-energy CT in Patients of Gastric Cancer	NCT05508126	Gastric Cancer ...	DECT examinatio... mpMRI examinati...	18 Years -	The First Affiliated Hospital with Nanjing Medical University
Study of CT and MR in the Gastric Cancer	NCT04028375	Gastric Cancer ... CT MRI Neoadjuvant The...	No intervention	18 Years - 80 Years	Henan Cancer Hospital
Multi-parametric MRI and Dual-energy CT in Patients of Gastric Cancer	NCT05508126	Gastric Cancer ...	DECT examinatio... mpMRI examinati...	18 Years -	The First Affiliated Hospital with Nanjing Medical University
Association Between Multiple Coagulation-related Factors and Lymph Node Metastasis in Patients With Gastric Cancer: A Retrospective Cohort Study	NCT05592925	Gastric Cancer ... Lymph Node Meta...	coagulation-rel...	-	Shandong Provincial Hospital
Complete Mesogastric Excision With D2 Lympadenectomy for Gastric Cancer:	NCT06281379	Gastric Cancer Gastric Neoplas... Gastric Cancer ...	Total mesogastr...	-	Başakşehir Çam & Sakura City Hospital
Association Between Multiple Coagulation-related Factors and Lymph Node Metastasis in Patients With Gastric Cancer: A Retrospective Cohort Study	NCT05592925	Gastric Cancer ... Lymph Node Meta...	coagulation-rel...	-	Shandong Provincial Hospital
Investigating the Experiences of Individuals With Gastric Cancer Participating in Clinical Trials	NCT05699278	Gastric Cancer		18 Years -	Power Life Sciences Inc.

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