Clinical trial: NCT03478449
Section: Confidentiality
Subsections: What Is The Confidentiality For Patients In This Clinical Trial?

We guarantee that there will never be any personal identification of your information in the research results, even if the research manuscript will be published in a journal. The research materials and specimens will be stored in the research hospital with the special person responsible for the custody. However, the bidding unit, the state food and drug administration and the ethics committee have the right to consult the subject's information. If you agree with the specimens applied to other medical trials by researches involved directly in the studies, we will promise that your personal identification information can not be contained in any datum or document.
Clinical trial: NCT03478449
Section: Participant Responsibilities
Subsections: What Are The Prerequisites For Patient'S Participating In This Study?

Firstly, you must sign this informed consent, representing you are volunteered to participate in this study. Furthermore, you must meet the recruited criteria of this study. They are as follows: no pregnancy, no history of other malignancies, no history of gastric cancer surgery or the neoadjuvant therapy.
Clinical trial: NCT03478449
Section: Participant's Rights
Subsections: What Are The Rights Of The Patients Participated In This Trial?

As your participation is voluntary, you may have the right to withdraw from this clinical trial at any time. Who can explain the inquiries for patients by telephone when they have problems? If you have any question related to this clinical trial, please directly contact the director of the research center who named as Jingyu Deng. The telephone number of Dr. Deng is 86-22-23340123-1061. The telephone number of ethics committee approved this clinical trial is 86-22-23524155.
Clinical trial: NCT03478449
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: What Are The Advantages To Patients For Participation In This Study?

This clinical trial can evaluate a reliable method for patients to exactly estimate the lymph node metastasis after curative gastrectomy, which may make an important contribution to precisely predict the prognosis. Is there any cost for the patient to participate in this clinical trial? No extra cost need to be paid by patients for participation in this clinical trial, with the exception of diagnostic and therapeutic costs of patients.
Clinical trial: NCT03478449
Section: Procedures
Subsections: Research Process

The study mainly collected specimens from two groups of people, including patients with gastric cancer confirmed by the histopathological examination and with potentially curative gastrectomy by the preoperative assessment. After patients sign the informed consents, research doctor will randomly allot the patients into fine lymph node sorting group or regional lymph node sorting group.
Clinical trial: NCT03478449
Section: Purpose of Research
Subsections: What Is The Aim Of Clinical Trial?

The aim of this clinical trial is to elucidate the impact of the different lymph node sorting methods on the migration of the pTNM classification for gastric cancer, which can provide the direct proofs to evaluate the optimal lymph node sorting method to obtain the accurate pTNM classification after curative surgery. The research programme and the informed consent have been approved by the ethics committee of the Tianjin cancer Institute and Hospital.