Stomach NeoplasmsCTC_ctDNANCT05208372
Detection of CTC and ctDNA in the Diagnosis of Metastasis in Gastric Cancer
An observational study of Stomach Neoplasms and Metastasis, run by First Hospital of China Medical University at 2 sites in China.
Trial summary
To investigate the value of CTCs and ctDNA in the diagnosis of metastasis in ascites/peritoneal flushing fluid and blood; To investigate the influence of laparoscopic CO2 pneumoperitoneum establishment on peritoneal and hematogenous metastasis of advanced gastric cancer; To explore the influence of the number and type… Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Stomach Neoplasms, Metastasis
- What is being tested?
- CTC test and ctDNA test
- How many people
- 200 participants
- Where
- 2 sitesChina
- Study dates
- 1 Jan 2022to 31 Jan 2024
- 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 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Borrmann III and Borrmann IV patients will be selected from Department of Oncology in hospitals. All patients will undergo either laparotomy or laparoscopic surgery.
Who may be able to join
- Patients who sign informed consent.
- Gastric cancer is determined by more than 2 pathologists.
- Patients with Borrmann III/IV gastric cancer.
Who cannot join
- Patients who complicate with other malignant tumors.
- Patients who complicate with other serious heart and lung diseases.
- Patients who receive preoperative neoadjuvant chemotherapy.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 1 recruiting
- Recruiting
First Hospital of Jinzhou Medical University
Jinzhou, Liaoning, 121012
Yubin Wang
- Active, not recruiting
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, 110000
About this study
Official title: Application of the Detection of Circulating Tumor Cell and Circulating Tumor DNA in the Diagnosis of Metastasis in Gastric Cancer
To investigate the value of CTCs and ctDNA in the diagnosis of metastasis in ascites/peritoneal flushing fluid and blood; To investigate the influence of laparoscopic CO2 pneumoperitoneum establishment on peritoneal and hematogenous metastasis of advanced gastric cancer; To explore the influence of the number and type of CTCs and ctDNA on metastasis and prognosis.
- Conditions
- Stomach Neoplasms, Metastasis
- Being tested
- CTC test, ctDNA test
- Keywords
- Diagnosis
- Medical subject headings
- Stomach Neoplasms, Neoplasm Metastasis, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTC testDiagnostic test
Circulating tumor cells test of ascites and blood for patients with gastric cancer.
ctDNA testDiagnostic test
Circulating tumor DNA test of ascites and blood for patients with gastric cancer.
| Study group | Role | What they receive |
|---|---|---|
| Laparotomy group | Patients who undergo radical laparotomy for gastric cancer. Receives: Diagnostic Test: CTC test; Diagnostic Test: ctDNA test | |
| Laparoscopy group | Patients who undergo laparoscope-assisted radical gastrectomy for gastric cancer. Receives: Diagnostic Test: CTC test; Diagnostic Test: ctDNA test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantity of CTCs
To count the circulating tumor cells in ascites and blood.
Measured: 1 day
Classification of CTCs
To classify the circulating tumor cells in ascites and blood.
Measured: 1 day
Expression of ctDNA
To assess the expression of circulating tumor DNA in ascites and blood, including YAP1, LAMC1 and DDIT4.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2022
- Study start1 Jan 2022
- Primary completion1 Feb 2023 (estimated)
- Study completion31 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stomach NeoplasmsStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Hospital of China Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kai Li, First Hospital of China Medical University
- Investigators
- Kai Li, MD, Study director, First Hospital of China Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05208372
- Sponsor's protocol ID
- FirstHCMU_CTC_ctDNA
- Acronym
- CTC_ctDNA
- Status last verified
- Jan 2022
- First submitted
- 13 Jan 2022
- Last updated
- 26 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of the Detection of Circulating Tumor Cell and Circulating Tumor DNA in the Diagnosis of Metastasis in Gastric Cancer
- ClinicalTrials.gov ID
- NCT05208372
- Acronym / sponsor ID
- CTC_ctDNA / FirstHCMU_CTC_ctDNA
- Conditions
- Stomach Neoplasms, Metastasis
- Keywords
- Diagnosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- First Hospital of China Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Feb 2023 (estimated)
- Study completion
- 31 Jan 2024 (estimated)
- First posted
- 26 Jan 2022 (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.
To investigate the value of CTCs and ctDNA in the diagnosis of metastasis in ascites/peritoneal flushing fluid and blood; To investigate the influence of laparoscopic CO2 pneumoperitoneum establishment on peritoneal and hematogenous metastasis of advanced gastric cancer; To explore the influence of the number and type of CTCs and ctDNA on metastasis and prognosis.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparotomy group | – | Diagnostic Test: CTC test, Diagnostic Test: ctDNA testPatients who undergo radical laparotomy for gastric cancer. |
| Laparoscopy group | – | Diagnostic Test: CTC test, Diagnostic Test: ctDNA testPatients who undergo laparoscope-assisted radical gastrectomy for gastric cancer. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Borrmann III and Borrmann IV patients will be selected from Department of Oncology in hospitals. All patients will undergo either laparotomy or laparoscopic surgery.
Key inclusion criteria (3 listed)
- Patients who sign informed consent.
- Gastric cancer is determined by more than 2 pathologists.
- Patients with Borrmann III/IV gastric cancer.
Key exclusion criteria (3 listed)
- Patients who complicate with other malignant tumors.
- Patients who complicate with other serious heart and lung diseases.
- Patients who receive preoperative neoadjuvant chemotherapy.
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 |
|---|---|---|
| CTC testCirculating tumor cells test of ascites and blood for patients with gastric cancer. | Diagnostic test | Laparoscopy group, Laparotomy group |
| ctDNA testCirculating tumor DNA test of ascites and blood for patients with gastric cancer. | Diagnostic test | Laparoscopy group, Laparotomy group |
Primary outcome
Quantity of CTCs
Time frame: 1 day
To count the circulating tumor cells in ascites and blood.
Classification of CTCs
Time frame: 1 day
To classify the circulating tumor cells in ascites and blood.
Expression of ctDNA
Time frame: 1 day
To assess the expression of circulating tumor DNA in ascites and blood, including YAP1, LAMC1 and DDIT4.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2022.
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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.
Kai Li, MD study director
First Hospital of China Medical University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stomach Neoplasms and Metastasis, run by First Hospital of China Medical University at 2 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 3 inclusion and 3 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 26 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Contact Kai Li, MD (8613998245233, cmu1h_likai@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantity of CTCs (time frame: 1 day). The study lists 3 primary outcomes in all. 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 26 Jan 2022.