Gastric CancerNCT06100003
A Clinical Study Aims to Assess the Consistency of Clinical Efficacy in Gastric Cancer Treatment and Drug Susceptibility Outcomes Using a Novel Drug Susceptibility Testing Method
An observational study of Gastric Cancer and Organoids, run by Funan Liu at 1 site in China.
Trial summary
The study is a real-world observational clinical study. Patients diagnosed as gastric cancer through histopathology were screened and enrolled. Before anti-tumor treatment, gastroscopy biopsy tissue specimens, surgical specimens, and malignant pleural effusion or ascites specimens, etc. are collected. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastric Cancer, Organoids
- How many people
- 104 participants
- Where
- 1 siteChina
- Study dates
- 18 Oct 2023to 1 Dec 2025
- 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
- Adult, Older adult
Study population: patients with gastric cancer in the First Affiliated Hospital of China Medical University
Who may be able to join
- Male or female, aged ≥ 18 and ≤80;
- Patients with gastric cancer diagnosed by histopathology;
- Patients who need neoadjuvant treatment; adjuvant therapy after radical surgery or palliative treatment;
- Fresh tumor tissue specimens or malignant pleural effusion or ascites can be obtained;
- Patients who sign the informed consent form, and are able to comply with the study period treatment process.
Who cannot join
- Inability to follow the research protocol;
- Inability to obtain relevant fresh specimens by biopsy/surgery/puncture;
- Concomitant contraindications to chemotherapy;
- pregnant or lactating women;
- Patients deemed inappropriate by investigators.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Phase I Clinical Trials Center Of The First Hospital of China Medical University
Shenyang, Liaoning, 110001
Shuhui Song, 02483281137, 593900927@qq.com
About this study
Official title: A Real-world Observational Clinical Study Aims to Assess the Consistency of Clinical Efficacy in Gastric Cancer Treatment and Drug Susceptibility Outcomes Using a Novel Drug Susceptibility Testing Method
The study is a real-world observational clinical study. Patients diagnosed as gastric cancer through histopathology were screened and enrolled. Before anti-tumor treatment, gastroscopy biopsy tissue specimens, surgical specimens, and malignant pleural effusion or ascites specimens, etc. are collected. The investigators will perform a drug sensitivity testing based on a novel drug susceptibility testing method to test the commonly used anti-tumor treatment regimens. Patients were given conventional anti-tumor treatment according to the medical judgment of the doctors. Finally, the investigator will evaluate the consistency of clinical efficacy in gastric cancer treatment and drug susceptibility outcomes.
- Conditions
- Gastric Cancer, Organoids
- Medical subject headings
- Stomach Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival
An Indicator of efficacy of postoperative adjuvant therapy
Measured: From date of surgery until the date of first documented recurrence，up to 3 years
Sensitivity
Cases in which drug susceptibility results are sensitive to the antineoplastic regimen as a percentage of the cases that are effective in clinical evaluation
Measured: Through study completion, an average of 1 year
Specificity
Cases in which drug susceptibility results are resistance to the antineoplastic regimen as a percentage of the cases that are ineffective in clinical evaluation
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2023
- Study start18 Oct 2023
- Primary completion31 Oct 2025 (estimated)
- Study completion1 Dec 2025 (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.
- 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
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Funan Liu
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese Academy of Sciences, Precedo Pharmaceuticals Co. Ltd., Suzhou Institute of Biomedical Engineering and Technology, Chinese Academy of Sciences, Suzhou 215163, China
- Responsible party
- Sponsor-investigator, Funan Liu, China Medical University, China
- Investigators
- Zhenning Wang, doctor, Principal investigator, The First Affiliated Hospital of China Medical UniveristyFunan Liu, doctor, Principal investigator, The First Affiliated Hospital of China Medical Univeristy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06100003
- Sponsor's protocol ID
- ZKPRS-CMU1H-01
- Status last verified
- Feb 2024
- First submitted
- 7 Oct 2023
- Last updated
- 7 Feb 2024
- 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 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-world Observational Clinical Study Aims to Assess the Consistency of Clinical Efficacy in Gastric Cancer Treatment and Drug Susceptibility Outcomes Using a Novel Drug Susceptibility Testing Method
- ClinicalTrials.gov ID
- NCT06100003
- Acronym / sponsor ID
- ZKPRS-CMU1H-01
- Conditions
- Gastric Cancer, Organoids
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Funan LiuUniversity, hospital or other
- Collaborators
- Chinese Academy of Sciences, Precedo Pharmaceuticals Co. Ltd., Suzhou Institute of Biomedical Engineering and Technology, Chinese Academy of Sciences, Suzhou 215163, China
- Study start
- 18 Oct 2023 (actual)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 25 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 study is a real-world observational clinical study. Patients diagnosed as gastric cancer through histopathology were screened and enrolled. Before anti-tumor treatment, gastroscopy biopsy tissue specimens, surgical specimens, and malignant pleural effusion or ascites specimens, etc. are collected. The investigators will perform a drug sensitivity testing based on a novel drug susceptibility testing method to test the commonly used anti-tumor treatment regimens. Patients were given conventional anti-tumor treatment according to the medical judgment of the doctors. Finally, the investigator will evaluate the consistency of clinical efficacy in gastric cancer treatment and drug susceptibility outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients with gastric cancer in the First Affiliated Hospital of China Medical University
Key inclusion criteria (5 listed)
- Male or female, aged ≥ 18 and ≤80;
- Patients with gastric cancer diagnosed by histopathology;
- Patients who need neoadjuvant treatment; adjuvant therapy after radical surgery or palliative treatment;
- Fresh tumor tissue specimens or malignant pleural effusion or ascites can be obtained;
- Patients who sign the informed consent form, and are able to comply with the study period treatment process.
Key exclusion criteria (5 listed)
- Inability to follow the research protocol;
- Inability to obtain relevant fresh specimens by biopsy/surgery/puncture;
- Concomitant contraindications to chemotherapy;
- pregnant or lactating women;
- Patients deemed inappropriate by investigators.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Disease-free survival
Time frame: From date of surgery until the date of first documented recurrence，up to 3 years
An Indicator of efficacy of postoperative adjuvant therapy
Sensitivity
Time frame: Through study completion, an average of 1 year
Cases in which drug susceptibility results are sensitive to the antineoplastic regimen as a percentage of the cases that are effective in clinical evaluation
Specificity
Time frame: Through study completion, an average of 1 year
Cases in which drug susceptibility results are resistance to the antineoplastic regimen as a percentage of the cases that are ineffective in clinical evaluation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
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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.
Zhenning Wang, doctor principal investigator
The First Affiliated Hospital of China Medical Univeristy
Funan Liu, doctor principal investigator
The First Affiliated Hospital of China Medical Univeristy
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 and Organoids, run by Funan Liu 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 7 Feb 2024. 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 Shuhui Song, bachelor (83281137 ext. 024, 593900927@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-free survival (time frame: From date of surgery until the date of first documented recurrence，up to 3 years). 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 7 Feb 2024.