Pilot Study of hPG80 (Circulating Progastrin) as a Blood Biomarker for High-grade Glial Tumors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Plasma concentrations of hPG80
研究概览
简要总结
PROGLIO is a French mono-centric study with longitudinal follow-up, in which patients with high grade brain tumors will be included. Blood samples will be taken during their therapeutic follow-up to evaluate plasma concentrations of hPG80 (circulating progastrin).
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
- •Female or male 18 years of age or older.
- •Patients with a high grade primary glial tumor (Astrocytoma grade 3; Glioblastoma; Anaplastic Oligodendroglioma)
- •Patients scheduled to begin radiation and/or chemotherapy.
- •Able to give informed consent to participate in the research.
- •Enrolled in a social security plan or beneficiary of such a plan.
排除标准
- •Patient under guardianship or curatorship
- •Psychological disorder (cognitive disorders, vigilance disorders, etc.) or social reasons (deprivation of liberty by judicial or administrative decision) or geographical reasons that could compromise the medical follow-up of the trial.
- •Refusal to participate.
- •Pregnant or breastfeeding woman.
研究组 & 干预措施
All patients
A fasting blood sample will be taken on the day of the beginning and the day of the end of the radiotherapy and during the adjuvant chemotherapy (every 3 cycles). A follow-up will be performed for 9 months, with a blood sample taken every three months on the day of the follow-up MRI.
干预措施: Blood sample (Biological)
结局指标
主要结局
Plasma concentrations of hPG80
时间窗: From Radiotherapy 1st session to 9 month follow-up
To evaluate plasma concentrations of hPG80 (circulating progastrin) during therapeutic and recurrence follow-up in patients with high-grade brain tumors.
次要结局
- Sensitivity of hPG80 concentration changes to irradiation(Through study completion, an average of 1 year and 6 months)
- Interindividual variations of hPG80 concentration(Through study completion, an average of 1 year and 6 months)
- hPG80 concentration according to tumor progression(Through study completion, an average of 1 year and 6 months)