Predictive Value of Progastrin Titer at Diagnosis and of Progastrin Kinetics During Treatment in Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 410
- 试验地点
- 17
- 主要终点
- ROC curve AUC regarding diagnostic accuracy of progastrin levels at baseline in cancer patients compared to non-cancer controls
研究概览
简要总结
Progastrin is a pro-hormone that, in physiological conditions, is maturated in gastrin in G cells of the stomach. The role of the gastrin is to stimulate the secretion of gastric acids during digestion. It is also important for the regulation of cell growth of the gastric mucosal.
In a healthy person, progastrin is not detectable in the peripheral blood. However, progastrin is abnormally released in the blood of patients with different cancers (colorectal, gastric, ovarian, breast, cervix uterus, melanoma...) The gene GAST coding for progastrin is a direct target gene of the WNT/ß-catenin oncogenic pathway. The activation of this oncogenic pathway is an early event in cancer development.
Chronic activation of the WNT/ß-catenin oncogenic pathway occurs in almost all human solid tumors and is a central mechanism in cancer biology that induces cellular proliferation, blocking of differentiation leading to primary tumor growth and metastasis formation.
Progastrin measured in the peripheral blood of patients on treatments, could be a new powerful marker for diagnosis and prognosis at different stages.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
ROC curve AUC regarding diagnostic accuracy of progastrin levels at baseline in cancer patients compared to non-cancer controls
时间窗: At baseline
Progastrin concentration in plasma samples will be measured with an ELISA Kit (CancerREAD LAB) provided by ECS Progastrin.
次要结局
- Longitudinal kinetic of progastrin values during treatments, assessed by modeled kinetic parameters of interest(6 years)
- Nycthemeral and weekly and post-operative progastrin variations(every 3 hours within 24 hours for the Nycthemeral cohort, and every week for 2 or 3 weeks for the weekly cohort)
- Determinants of progastrin serum values: hepatic function(6 years)
- Determinants of progastrin serum values: renal function(6 years)
- Determinants of progastrin serum values: age(at the inclusion)
- Determinants of progastrin serum values: gender(at the inclusion)
- Overall survival(6 years)
- recurrence free survival(6 years)
- progression free survival(6 years)
- The tumor size at cancer diagnosis(At baseline)
- Complete surgery(6 years)
- time to recurrence (for patients enrolled in curative intent cohorts).(6 years)
- time to progression (for patients enrolled in non-curative intent cohorts)(6 years)
- time to death (whenever it occurred)(6 years)
- Comparison of the initial values and of the kinetics of other serum tumor markers (CA15-3, CA 19-9, CA125, CEA, PSA, AFP) with those of progastrin(at the baseline)