Quantitative Detection of CEA mRNA in the Smog and Tissue Exudate Whole Process Collected During Laparoscopic (Robotic) Radical Gastrectomy in Gastric Cancer Patients

NCT06076265 | Unknown DMC

• 1 other identifier: SMOG01
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this SMOG 01 study is to observe the possibility of intraperitoneal dissemination of tumor cells throughout the entire laparoscopic (robotic) radical gastrectomy for gastric cancer and explore its related mechanisms and potential clinical significance with peritoneal metastasis.

Conditions

Gastric Cancer

Keywords

Advanced Gastric Cancer; Laparoscopic(Robotic) Gastrectomy; RT-PCR; CEA; Free intraperitoneal tumor cells

Outcome Measures

Primary Outcomes (1)

• Positive detection rate of CEA

  Positive detection rate of CEA

  Supervision of the whole operation: collection of peritoneal lavage fluid at three time points, before the start of the operation, during the operation, and at the end of the operation

Study Arms (1)

Single arm group

Procedure: Radical Gastric Cancer Surgery

Interventions

Radical Gastric Cancer Surgery PROCEDURE

Laparoscopic (robotic) radical surgery for gastric cancer

Single arm group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Gastric cancer patients over 18 years old who plan to undergo radical gastrectomy for gastric cancer

You may qualify if:

• Gastric adenocarcinoma confirmed by preoperative pathology
• Endoscopic and CT/MRI enhanced examination confirmed that cT1-4aN0-3M0 has the possibility of resection
• To undergo radical gastrectomy (laparoscopic or robotic) under general anesthesia+/- epidural anesthesia (carbon dioxide pneumoperitoneum)
• Willing and able to comply with the research protocol
• Reach a written consent agreement before registration, and fully realize the right to withdraw from the study at any time without any loss

You may not qualify if:

• Urgent surgery is required due to tumor emergencies (such as bleeding, perforation, and obstruction)
• Extensive peritoneal metastasis can be seen during intraoperative exploration
• Other diseases requiring simultaneous surgery
• Patients with ascites
• Pregnancy

Sponsors & Collaborators

• The Affiliated Hospital of Qingdao University: lead

Study Sites (1)

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Zhou Yanbing, MD

  The Affiliated Hospital of Qingdao University

  STUDY DIRECTOR

Central Study Contacts

Zhou Yanbing, MD

CONTACT

86532-82911324; zhouyanbing@qduhospital.cn

Zhang Peng, MM

CONTACT

86532-17854217082; zzzp15171088311@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2023
• First Posted: October 10, 2023
• Study Start: December 1, 2022
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2023
• Last Updated: October 10, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

CN (1)