NCT02050737终止不适用
Identification of Plasma Biomarkers in Early Detection of Colorectal Adenocarcinoma Recurrence (C-RAC Plasma Biomarker Study)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 109
- 试验地点
- 14
- 主要终点
- Disease free survival or progression free survival
研究概览
简要总结
This is an exploratory, translational, non-interventional and multi-centre clinical study.
详细描述
Cohort A will consist of 100 CRAC patients with stage II/III resectable disease due for adjuvant chemotherapy.
Cohort B will consist of 30 patients with stage II resectable disease for observation only.
Both cohorts will have a follow up period of up to 2 years, post chemotherapy for cohort A and post resection for cohort B.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient must be able to give written informed consent
- •Histologically or cytologically confirmed CRAC
- •Cohort A: colorectal cancer patients with stage II/III resectable disease due for adjuvant chemotherapy OR Cohort B: colorectal cancer patients with stage II resectable disease for observation only
- •Age ≥ 18 years
- •Treatment with curative intent
- •Eastern Cooperative Oncology Group (ECOG) Performance status 0 - 2
排除标准
- •Presence of a medical or psychiatric condition, which, in the opinion of the investigator, would potentially pose a risk to the patient when participating in this trial
- •Evidence of a metastatic disease
结局指标
主要结局
Disease free survival or progression free survival
时间窗: Duration of treatment and follow up, expected to be 4 years
Identify plasma biomarkers with improved sensitivity to predict early recurrence of CRAC and presence of residual occult metastases following completion of adjuvant chemotherapy
次要结局
- Accuracy, sensitivity, specificity and concordance index(Duration of treatment and follow up period, expected to be 4 years)
- To investigate the correlation between biomarkers identified in plasma samples with the expression of the same biomarkers at tissue level.(For the duration of treatment and follow up, expected to be 4 years)
研究者
研究点 (14)
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