Impact of Pesticide Exposure on Survival and Tumor Aggressiveness in Patients With Glioblastoma: A Prospective Clinical Study
NCT07788430 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120
Last updated 2026-08-26
Summary
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.
Conditions
- Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype
Interventions
- OTHER
-
Biological sample collection
At the baseline visit, the following biological sample collection will be carried out: * Urine sample (15 mL) * Hair sample (50 to 100 hairs) * Optional blood sample (40 mL)
- OTHER
-
Self-reported questionnaire
At the baseline visit, the patient will be handed a blank copy of the questionnaire to be completed at home. The patient will be asked to return the completed questionnaire within 1 month. Within two weeks of receipt, a member of the investigator staff will review the questionnaire for completeness and consistency and if necessary will make a follow-up phone call to the patient for clarification. If, based on the patient answers, a suspicion of occupational pesticide exposure is identified, the patient will be provided with a second part of the questionnaire in order to enhance the granularity of the answers. The patient will be given one month to return the questionnaire part 2 to the site staff. Within two weeks of receipt of the second part of the questionnaire, a member of the investigator staff will review it and contact the patient if necessary (see questionnaire part 1) The questionnaire part 1 should take about 1h and the part 2 about 30 minutes to fill out.
Sponsors & Collaborators
-
Institut National de la Santé Et de la Recherche Médicale, France
collaborator OTHER_GOV -
Institut Claudius Regaud
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- HEALTH_SERVICES_RESEARCH
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-10-15
- Primary Completion
- 2031-10-15
- Completion
- 2031-10-15
Countries
- France
Study Locations
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