Identification of Novel Therapeutic Targets in Gastric Cancer With Lymph Node or Distant Metastasis: An Explorative Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Biobank construction
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Biobank construction
时间窗: 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.
时间窗: 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
时间窗: 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.
次要结局
- Clinical Outcome - Overall survival(through study completion, an average of 5 year)
- Clinical Outcome - Progression-free survival(through study completion, an average of 5 year)
- Clinical Outcome - Karnofsky Score(At baseline measurement)
- Clinical Outcome - Time point of metastasis(Recruitment till death or 5 year)
- Clinical Outcome - Number of previous chemotherapy/ target therapy/ immunotherapy(Measured and asked at baseline)
- Clinical Outcome - Presence of ascites(Recruitment till death or 5 year)
- Clinical Outcome - Cancer Restaging(Post-treatment till death or 5 year)
研究者
CHAN SHANNON MELISSA
Assistant Professor
Chinese University of Hong Kong