- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07551440
Identification of Therapeutic Targets in Metastatic Gastric Cancer
April 22, 2026 updated by: CHAN SHANNON MELISSA, Chinese University of Hong Kong
Identification of Novel Therapeutic Targets in Gastric Cancer With Lymph Node or Distant Metastasis: An Explorative Study
This is a pilot study aiming at identifying novel therapeutic molecular targets in patients with gastric cancer with lymph nodes or distant metastasis.
All patients who are diagnosed with gastric cancer with metastases in the Prince of Wales Hospital will be screened for eligibility.
Study Overview
Status
Recruiting
Conditions
Study Type
Observational
Enrollment (Estimated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Shannon Melissa Chan, PhD
- Phone Number: 35052627
- Email: shannonchan@surgery.cuhk.edu.hk
Study Locations
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Hong Kong, Hong Kong, 0000
- Recruiting
- The Chinese University of Hong Kong
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Contact:
- Shannon Chan
- Phone Number: 35052627
- Email: shannonchan@surgery.cuhk.edu.hk
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
Patients admitted into PWH
Description
Inclusion Criteria:
- Patients age >= 18, <= 80 years old
- Performance status (WHO) <=2
- Gastric adenocarcinoma with lymph node metastasis or distant metastasis such as liver metastases, lung metastases, bone metastases, peritoneum metastases
- Patients with isolated ovarian metastasis could be included
- Patients who will be undergoing neoadjuvant chemotherapy/ target therapy/ immunotherapy or palliative chemotherapy/ target therapy/ immunotherapy
- Ability to give written consent before the commencement of treatment
Exclusion Criteria:
- Patient who will not be undergoing neoadjuvant chemotherapy/ target therapy/ immunotherapy or palliative chemotherapy/ target therapy/ immunotherapy
- Pregnancy or breastfeeding
- Patients with irreversible coagulation disorders
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Biobank construction
Time Frame: Collect at baseline(pre-treatment) and/or during interval surgery if clinically indicated and/or after completing all systemic and surgical treatment if patient required an endoscopy or laparoscopy due to clinical need only.
|
Recruit patients and collect the required biological samples (i.e.
tumor tissues, blood and ascites samples) for biobank construction.
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Collect at baseline(pre-treatment) and/or during interval surgery if clinically indicated and/or after completing all systemic and surgical treatment if patient required an endoscopy or laparoscopy due to clinical need only.
|
|
Detection of noval therapeutic targets for treating gastric cancer cancer with metastases.
Time Frame: Collect at baseline(pre-treatment) and/or during interval surgery if clinically indicated and/or after completing all systemic and surgical treatment if patient required an endoscopy or laparoscopy due to clinical need only.
|
Biological samples (i.e.
tissue, blood and ascites samples) collected from enrolled patients will be used in genome and transcriptome analysis using next generation sequencing, DNA mutation detection using digital PCR and mass spectrometry-based proteomic.
|
Collect at baseline(pre-treatment) and/or during interval surgery if clinically indicated and/or after completing all systemic and surgical treatment if patient required an endoscopy or laparoscopy due to clinical need only.
|
|
Organoid culture for drug sensitivity assay
Time Frame: Collect at baseline(pre-treatment) and/or during interval surgery if clinically indicated and/or after completing all systemic and surgical treatment if patient required an endoscopy or laparoscopy due to clinical need only.
|
Gastric tumor tissues are collected from enrolled patients to establish patient-derived organoids and subject to drug sensitivity assay.
The choice of drugs will depend on the molecular analysis results and will be advised by oncologists.
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Collect at baseline(pre-treatment) and/or during interval surgery if clinically indicated and/or after completing all systemic and surgical treatment if patient required an endoscopy or laparoscopy due to clinical need only.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Clinical Outcome - Overall survival
Time Frame: through study completion, an average of 5 year
|
Patients' overall survival will also be recorded.
|
through study completion, an average of 5 year
|
|
Clinical Outcome - Progression-free survival
Time Frame: through study completion, an average of 5 year
|
Patients' progression-free survival will also be recorded.
|
through study completion, an average of 5 year
|
|
Clinical Outcome - Karnofsky Score
Time Frame: At baseline measurement
|
Karnofsky Score for measuring quality of life will be recorded
|
At baseline measurement
|
|
Clinical Outcome - Time point of metastasis
Time Frame: Recruitment till death or 5 year
|
Patients' time point of metastasis, whether it is synchronous or metachronous will be recorded
|
Recruitment till death or 5 year
|
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Clinical Outcome - Number of previous chemotherapy/ target therapy/ immunotherapy
Time Frame: Measured and asked at baseline
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Number of previous chemotherapy/ target therapy/ immunotherapy received by the patients will be recorded
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Measured and asked at baseline
|
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Clinical Outcome - Presence of ascites
Time Frame: Recruitment till death or 5 year
|
Presence of ascites on recruited patients will be recorded
|
Recruitment till death or 5 year
|
|
Clinical Outcome - Cancer Restaging
Time Frame: Post-treatment till death or 5 year
|
Stage of cancer will be recorded and determined with CT/PETCT scan
|
Post-treatment till death or 5 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 15, 2023
Primary Completion (Estimated)
April 1, 2033
Study Completion (Estimated)
October 1, 2033
Study Registration Dates
First Submitted
August 10, 2023
First Submitted That Met QC Criteria
April 22, 2026
First Posted (Actual)
April 24, 2026
Study Record Updates
Last Update Posted (Actual)
April 24, 2026
Last Update Submitted That Met QC Criteria
April 22, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023.117
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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