Prospective Exploratory Study of a Multiomic Blood Biomarker Panel to Predict Chemotherapy-Induced Peripheral Neuropathy (CIPN)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 192
- 主要终点
- Neuropathy prediction
研究概览
简要总结
The goal of this prospective, multicenter, observational cohort study with longitudinal blood sampling and standardized neurological evaluation over 6 months is to identify biomarkers to predict the overall occurrence of chronic chemotherapy-induced peripheral neuropathy (CIPN, any grade), in each of two treatment subgroups (taxanes and oxaliplatin). It involves integration of clinical data and plasma multiomic biomarkers (proteomic + metabolomic panel) analyzed via supervised machine learning to identify predictive features of CIPN.
详细描述
In this prospective exploratory cohort study based on artificial intelligence data analysis, we aim to identify useful markers to predict the occurrence of CIPN in patients receiving taxanes or oxaliplatin to treat their cancers.
We plan to recruit 192 consecutive patients from 2 hospitals (Hôpital Forcilles and Centre Hospitalier de Bligny) treated for cancer, aimed to receive a prolonged treatment (9 weeks or more) with a neurotoxic drug: taxanes (subgroup 1: 78 patients), and oxaliplatin (subgroup 2: 114 patients). Study design is built to detect promising markers (including biomarkers from our exclusive panel) possibly linked to neuropathy that could help predict its occurrence and clinically meaningful impact. A balanced selection was made to enable the collection of as much information as possible while limiting the impact on patients. Patients will be included before treatment and follow-up will last 6 months after start of treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have received detailed information about the study and have signed, with the investigator, a consent form to participate in the study
- •Patients being treated for cancer at any stage of the disease and scheduled to receive chemotherapy including one (and only one) of the following molecules: paclitaxel, docetaxel, or oxaliplatin, for a planned duration of 9 weeks or more
- •Age > 18 years
- •Life expectancy > 3 months
- •Patient affiliated with or entitled to social security
排除标准
- •Patients already suffering from neuropathy or chronic neurogenic pain
- •Patients with type 1 or type 2 diabetes (for more than 10 years for type 2 diabetes)
- •Patients who have already received neurotoxic cancer treatment including those in clinical trials
- •Patients receiving two of the study molecules simultaneously (only one study molecule is permitted, including in combination chemotherapy but that does not include another neurotoxic molecule)
- •Patients receiving immunotherapy
结局指标
主要结局
Neuropathy prediction
时间窗: From enrollment to 6 months after.
1\. To predict the occurrence of severe CIPN defined as grade 3 chronic neuropathy measured with appropriate tool (cf related section), in each of the two treatment subgroups (taxanes and oxaliplatin).
次要结局
- Neuropathy severity prediction(From enrollment to 6 months after)
- Time to onset of chronic neuropathy(from enrollment to 6 months after)