Impact of Pesticide Exposure on Survival and Tumor Aggressiveness in Patients With Glioblastoma: A Prospective Clinical 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.

Interventions

• Biological sample collection · OTHER

  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)

• Self-reported questionnaire · OTHER

  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.

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

Sites (1)

• Institut Universitaire du Cancer de Toulouse - Oncopole, Toulouse, France