Stomach Neoplasms, Benign
Conditions
Keywords
gastric cancer, metastatic, therapeutic targets
Brief summary
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.
Interventions
None listed
Sponsors
Study design
Eligibility
Inclusion criteria
1. Patients age \>= 18, \<= 80 years old 2. Performance status (WHO) \<=2 3. Gastric adenocarcinoma with lymph node metastasis or distant metastasis such as liver metastases, lung metastases, bone metastases, peritoneum metastases 4. Patients with isolated ovarian metastasis could be included 5. Patients who will be undergoing neoadjuvant chemotherapy/ target therapy/ immunotherapy or palliative chemotherapy/ target therapy/ immunotherapy 6. Ability to give written consent before the commencement of treatment
Exclusion criteria
1. Patient who will not be undergoing neoadjuvant chemotherapy/ target therapy/ immunotherapy or palliative chemotherapy/ target therapy/ immunotherapy 2. Pregnancy or breastfeeding 3. Patients with irreversible coagulation disorders
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Biobank construction | 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. |
| Detection of noval therapeutic targets for treating gastric cancer cancer with metastases. | 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. |
| Organoid culture for drug sensitivity assay | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Outcome - Overall survival | through study completion, an average of 5 year | Patients' overall survival will also be recorded. |
| Clinical Outcome - Progression-free survival | through study completion, an average of 5 year | Patients' progression-free survival will also be recorded. |
| Clinical Outcome - Karnofsky Score | At baseline measurement | Karnofsky Score for measuring quality of life will be recorded |
| Clinical Outcome - Time point of metastasis | Recruitment till death or 5 year | Patients' time point of metastasis, whether it is synchronous or metachronous will be recorded |
| Clinical Outcome - Number of previous chemotherapy/ target therapy/ immunotherapy | Measured and asked at baseline | Number of previous chemotherapy/ target therapy/ immunotherapy received by the patients will be recorded |
| Clinical Outcome - Presence of ascites | Recruitment till death or 5 year | Presence of ascites on recruited patients will be recorded |
| Clinical Outcome - Cancer Restaging | Post-treatment till death or 5 year | Stage of cancer will be recorded and determined with CT/PETCT scan |
Countries
Hong Kong