Clinical Study of Metabolomics-based Approach Explore Biomarkers for Metastatic Breast Cancer
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Metabolites changes of plasma by High Performance Liquid Chromatography-Mass Spectrometry (LC-MS).
研究概览
简要总结
RATIONALE: Studying samples of plasm by metabolomics-based approach from women with metastasis breast cancer may help doctors understand the biomarker of visceral metastasis.
PURPOSE: This clinical trial is studying the biomarker of visceral metastasis by metabolomics approach in metastasis breast cancer undergoing treatment.
详细描述
Imaging evaluation of the effect of chemotherapy on patients with visceral metastases from breast cancer, metabolomics was used to analyze the changes of metabolites in plasma, and to find biomarkers that could reflect visceral metastasis and treatment effects. The purpose is to help clinicians predict whether patients have potential visceral metastases, evaluate the effects of visceral metastasis treatment, and reflect the patient's prognosis.
Patients with visceral metastases on imaging examinations received chemotherapy as planned, and blood samples were collected from patients before and during imaging assessments. Analysis of metabolites in plasma using ultra high performance liquid chromatography. Patient information were collected through medical record, including race, age, height and body mass index, menarche age, menstrual status, menopausal age (if applicable), tobacco and alcohol history, motherhood history, family history, etc.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age: 18-70 yrs.
- •Any menopausal status.
- •Any hormone receptor status.
- •Patients must have histologically or imaging confirmed breast cancer with visceral metastatic.
- •Patients must have measurable disease, per RECIST criteria v1.1.
- •Estimated life expectancy of ≥ 12 weeks.
- •Ability to swallow oral medications.
- •Participants must have adequate organ function as defined by:
- •ANC ≥1.5 x 109/L, platelet count ≥100 x 109/L, haemoglobin ≥ 10 g/dL.
- •creatinine < 1.5 x UNL (upper normal limit).
- •Total bilirubin < 1.5x UNL.
- •ALT & AST < 2.5xUNL; alkaline phosphatase < 2.5xUNL.
- •Creatine phosphokinase (CPK) ≤ 2.5 x UNL.
- •Patients with CNS metastatic disease are allowed if the disease is controlled and stable for at least 3 months by CT or MRI.
排除标准
- •Current severe, uncontrolled systemic disease (e.g. pulmonary, or metabolic disease; wound healing disorders; ulcers; or bone fractures).
- •History of other malignancies.
- •No measureable lesion is present, as defined by RECIST 1.
- •Patients who suffer from a medical or psychiatric condition that, in the opinion of the principal investigator, would impair their ability to participate in the study.
- •Concurrent interventional studies.
研究组 & 干预措施
only liver metastasis
There is no other intervention, only clinical treatment.
干预措施: There is no other intervention, only clinical treatment. (Drug)
only lung metastasis
There is no other intervention, only clinical treatment.
干预措施: There is no other intervention, only clinical treatment. (Drug)
No distant metastasis
There is no other intervention, only clinical treatment.
干预措施: There is no other intervention, only clinical treatment. (Drug)
结局指标
主要结局
Metabolites changes of plasma by High Performance Liquid Chromatography-Mass Spectrometry (LC-MS).
时间窗: up to six months
To assess the changes of metabolites during the process of our observation, and to find out the relationship between metabolite(s) and therapeutic effect.
次要结局
- progression of disease(Up to 10 years)
- overall survival(Up to 10 years)
研究者
Zhiyong Yu
Head of Breast surgery
Shandong Cancer Hospital and Institute