Gastric CancerNCT06076265
Quantitative Detection of CEA mRNA in the Smog and Tissue Exudate Whole Process Collected During Laparoscopic (Robotic) Radical Gastrectomy in Gastric Cancer Patients
An observational study of Gastric Cancer, run by The Affiliated Hospital of Qingdao University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Radical Gastric Cancer Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2022to Oct 2023
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Gastric cancer patients over 18 years old who plan to undergo radical gastrectomy for gastric cancer
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Affiliated Hospital of Qingdao University
Qingdao, Shandong
Zhou Yanbing, MD, 86532-82911324, zhouyanbing@qduhospital.cn
Zhang Peng, MM, 86532-17854217082, zzzp15171088311@163.com
About this study
Official title: Quantitative Detection of CEA mRNA in the Smog and Tissue Exudate Whole Process Collected During Laparoscopic (Robotic) Radical Gastrectomy in Gastric Cancer Patients: Study Protocol for a Single Center Prospective, Single-arm, Longitudinal Pilot Study（SMOG 01Study）
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.
Read the detailed description
Cytological examination of peritoneal lavage fluid has become an important parameter for pathological staging and prognosis judgment of gastric cancer. However, the vast majority of previous studies have only focused on collecting peritoneal lavage fluid through laparotomy or laparoscopic exploration for cytological and tumor marker monitoring as further tumor staging. Unfortunately, there is no research focusing on whether laparoscopic (or robotic) surgery under the carbon dioxide pneumoperitoneum environment can cause the iatrogenic spread of cancer cells, and there is also a lack of a practical and feasible method to collect smog and tissue exudates generated throughout the entire surgical process for cytological monitoring, to determine whether laparoscopic surgery itself may cause the iatrogenic spread of tumor cell, to uncover the potential mechanisms and propose appropriate preventive measures of peritoneal metastasis. Therefore, the investigators have designed a special device to collect smog and tissue exudates generated during laparoscopic or robotic radical gastrectomy to determine whether there is a possibility of iatrogenic cancer cell dissemination in the abdominal cavity throughout the entire course of laparoscopic or robotic surgery by using RT-PCR to detect CEA mRNA, which can become one of the reasons for gastric cancer peritoneal metastasis.
- Conditions
- Gastric Cancer
- Being tested
- Radical Gastric Cancer Surgery
- Keywords
- Advanced Gastric Cancer, Laparoscopic(Robotic) Gastrectomy, RT-PCR, CEA, Free intraperitoneal tumor cells
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radical Gastric Cancer SurgeryProcedure or surgery
Laparoscopic (robotic) radical surgery for gastric cancer
| Study group | Role | What they receive |
|---|---|---|
| Single arm group | Not described Receives: Procedure: Radical Gastric Cancer Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive detection rate of CEA
Positive detection rate of CEA
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start1 Dec 2022
- Primary completionOct 2023 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by The Affiliated Hospital of Qingdao 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Qingdao University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhou Yanbing, MD, Study director, The Affiliated Hospital of Qingdao University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06076265
- Sponsor's protocol ID
- SMOG01
- Status last verified
- Oct 2023
- First submitted
- 20 Sep 2023
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Detection of CEA mRNA in the Smog and Tissue Exudate Whole Process Collected During Laparoscopic (Robotic) Radical Gastrectomy in Gastric Cancer Patients: Study Protocol for a Single Center Prospective, Single-arm, Longitudinal Pilot Study（SMOG 01Study）
- ClinicalTrials.gov ID
- NCT06076265
- Acronym / sponsor ID
- SMOG01
- Conditions
- Gastric Cancer
- Keywords
- Advanced Gastric Cancer, Laparoscopic(Robotic) Gastrectomy, RT-PCR, CEA, Free intraperitoneal tumor cells
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- The Affiliated Hospital of Qingdao UniversityUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 10 Oct 2023 (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.
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.
Detailed description
Cytological examination of peritoneal lavage fluid has become an important parameter for pathological staging and prognosis judgment of gastric cancer. However, the vast majority of previous studies have only focused on collecting peritoneal lavage fluid through laparotomy or laparoscopic exploration for cytological and tumor marker monitoring as further tumor staging. Unfortunately, there is no research focusing on whether laparoscopic (or robotic) surgery under the carbon dioxide pneumoperitoneum environment can cause the iatrogenic spread of cancer cells, and there is also a lack of a practical and feasible method to collect smog and tissue exudates generated throughout the entire surgical process for cytological monitoring, to determine whether laparoscopic surgery itself may cause the iatrogenic spread of tumor cell, to uncover the potential mechanisms and propose appropriate preventive measures of peritoneal metastasis. Therefore, the investigators have designed a special device to collect smog and tissue exudates generated during laparoscopic or robotic radical gastrectomy to determine whether there is a possibility of iatrogenic cancer cell dissemination in the abdominal cavity throughout the entire course of laparoscopic or robotic surgery by using RT-PCR to detect CEA mRNA, which can become one of the reasons for gastric cancer peritoneal metastasis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm group | – | Procedure: Radical Gastric Cancer Surgery |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Gastric cancer patients over 18 years old who plan to undergo radical gastrectomy for gastric cancer
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Radical Gastric Cancer SurgeryLaparoscopic (robotic) radical surgery for gastric cancer | Procedure or surgery | Single arm group |
Primary outcome
Positive detection rate of CEA
Time frame: 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
Positive detection rate of CEA
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
- Individual participant dataSharing planned: Yes
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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.
Zhou Yanbing, MD study director
The Affiliated Hospital of Qingdao University
1 site 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, run by The Affiliated Hospital of Qingdao University at 1 site 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 5 inclusion and 5 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 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Contact Zhou Yanbing, MD (86532-82911324, zhouyanbing@qduhospital.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive detection rate of CEA (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Oct 2023; AzTrials last refreshed its copy on 6 Nov 2026.