Impact of Pesticide Exposure on Survival and Tumor Aggressiveness in Patients With Glioblastoma: A Prospective Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
This prospective, interventional, monocentric study will aim at investigating the relationship between pesticide exposure and the treatment response of patients with GBM.
The study will be conducted on a population of 120 participants aged over 18 years, diagnosed with IDH wild-type GBM, and who will receive the treatment for GBM (by, where applicable, concomitant radiochemotherapy or chemotherapy in combination with targeted therapy).
The recruitment period will last 2 years. After eligibility is confirmed, study assessments will be performed at the baseline visit (i.e. before GBM treatment initiation). The study specific assessments consist of: biological sample collection (urine, hair and blood) and completion of a self-reported questionnaire.
The questionnaire will entail 2 parts: i- the main part delivered to all participants, ii- an optional part delivered only when a professional pesticide exposure is suspected (based on answers provided in part 1).
Then, the patient will be followed up for about 3 years (or 6 timepoints) for data collection. During this period, data collection will take place twice a year according to the routine visits at the investigator site for clinical benefit assessment to document tumor response, survival status and further anti-cancer treatments if applicable. This data is routinely captured in patient's medical records per SOC and will not require study specific visits.
The follow-up period might differ between patients as it will depend on the routine visit schedule. This schedule will be set up for each patient specifically according to their SOC.
详细描述
The study assessments entail: biological sample collection and self-reported questionnaire completion.
- After the biological sample (urine and hair) collection, samples will be transfered to the Limoges Hospital for analysis (detection of pesticides residus and metabolites).
- After the optional blood sample collection, samples will be processed (Peripheral Blood Mononuclear Cell isolation) and stored at the sponsor site for constitution of a biobank (plasma and PBMC).
- The data pertaining to the self-reported questionnaires will be transfered to the INSERM team in Bordeaux for epidemiology analysis. The resulting Pesticides Exposure Scores will be integrated in the clinical database. No patient confidential information will be retained by the sub-contracting INSERM team after the end of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 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
- •1. Patient newly diagnosed with IDH wild-type GBM
- •2. Age >18 years old at the time of study entry
- •3. Patient who have not yet started the treatment for GBM (by, where applicable, concomitant radiochemotherapy or chemotherapy in combination with targeted therapy)
- •4. Patient having signed an informed consent form prior to any study-related procedures
- •5. Patient able to participate and willing to comply with the study procedures
- •6. Patient affiliated to a Social Health Insurance in France
排除标准
- •1. Any condition contra-indicating sampling procedures required by the protocol.
- •2. Any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure
- •3. Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice)
研究组 & 干预措施
Study assessments
The same study assessments will apply to all study participants
干预措施: Biological sample collection (Other)
Study assessments
The same study assessments will apply to all study participants
干预措施: Self-reported questionnaire (Other)
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: through study completion, an average of 5 years
PFS is defined as the time from inclusion until progression (according to the investigator's judgment) or death. Patients alive without documented progression at last-follow-up news will be censored at this date.
Pesticide Exposure
时间窗: through study completion, an average of 5 years
A patient is considered as exposed to pesticides if he meets at least one of the two following conditions: * probability of professional exposure \> 90% in at least one occupation * environmental exposure
次要结局
- Overall Survival (OS)(through study completion, an average of 5 years)
- Pesticide Exposure(through study completion, an average of 5 years)