A Study Comparing the Gene Profiles of Primary and Heterogeneous Metastases of Colorectal Cancer
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Mutation Consistency of metastatic and primary sites of colorectal cancer patients with postoperative metastasis
研究概览
简要总结
The incidence and mortality of colorectal cancer in China's cancer disease spectrum is on the rise, and it is a common malignant tumor that harms the health of Chinese residents.In patients with synchronous metastatic colorectal cancer, RAS status is highly consistent in primary focus and metastasis, so NCCN guidelines recommend RAS testing of primary or metastatic tissue is feasible .However, there are also some reports that the difference of RAS status between primary and metastatic lesions was up to 22%.In additiont,there are few studies on whether the gene profile of the metastatic lesion is the same as that of the primary lesion in patients with postoperative heterogeneous metastasis in patients with stage III colorectal cancer.
详细描述
The incidence and mortality of colorectal cancer in China's cancer disease spectrum is on the rise, and it is a common malignant tumor that harms the health of Chinese residents. Now NCCN guidelines recommend targeted drugs for the treatment of metastatic colorectal cancer mainly including cetuximab and panizumab whic targeting EGFR , as well as the bevacizumab and arber regofini, etc which targeing anti-angiogenic.Cetuximab and panizumab are only effective in patients with RAS wild type.
Previous studies have shown that In patients with synchronous metastatic colorectal cancer, RAS status is highly consistent in primary focus and metastasis, so NCCN guidelines recommend RAS testing of primary or metastatic tissue is feasible .However, there are also some reports that the difference of RAS status between primary and metastatic lesions was up to 22%.In additiont,there are few studies on whether the gene profile of the metastatic lesion is the same as that of the primary lesion in patients with postoperative heterogeneous metastasis in patients with stage III colorectal cancer.
Therefore, it has important clinical significance to compare the difference of gene profile between metastatic lesion and primary lesion in patients with postoperative metastasis of stage III colorectal cancer.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years old and ≤ 75 years old, both men and women;
- •Patients must have histologically confirmed metastatic colorectal adenocarcinoma and metastases can be punctured by interventional evaluation;
- •ECOG: 0 to 2;
- •Expected survival ≥ 12 weeks;
- •Absolute neutrophil count (ANC) ≥ 1.5 × 109 /L; Hemoglobin ≥ 8g / dL; Platelets ≥100×109/L;(According to the normal value of the clinical trial center)
- •Prothrombin time (PT) < 1.5 times the upper normal limit and thrombin time (APTT) < 1.5 times the upper normal limit;
- •Informed consent has been signed.
排除标准
- •Patients had surgery within three weeks will be excluded.
- •Patients have known or suspected brain metastases will be excluded.
- •Pregnant or nursing women will be excluded.
- •Patients with severe uncontrolled systemic disease, such as severe active infection, will be excluded.
- •Patients had other malignancies in the past 5 years will be excluded, except cervical carcinoma in situ or basal cell carcinoma of the skin.
- •Patients who were unable to complete the study or sign valid informed consent for medical, social or psychological reasons, which will be determined by researcher, will be excluded.
- •Organ transplant recipients who need immunosuppressive therapy will be excluded.
- •People have been known to be infected with immunodeficiency virus (HIV) or have been known to be serologically positive for HIV will be excluded.
结局指标
主要结局
Mutation Consistency of metastatic and primary sites of colorectal cancer patients with postoperative metastasis
时间窗: through study completion, an average of 2 years.
We do NGS sequencing of both the primary and metastatic tissue sample of the CRC patients. The gene mutation data will be analysis, and the percentage of same and different mutation of the samples will be compared.
次要结局
- Mutation Consistency of tissue and blood sample(through study completion, an average of 2 years.)
研究者
Ruihua Xu
Dean, Chief Physician, headof Gastroenterology, Professor#Principal Investigator, Clinical Professor
Sun Yat-sen University