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

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07788430 on ClinicalTrials.gov