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NCT07788430
Impact of Pesticide Exposure on Survival and Tumor Aggressiveness in Patients With Glioblastoma: A Prospective Clinical Study
Conditions: Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 120
Sponsor: Institut Claudius Regaud
Location: Institut Universitaire du Cancer de Toulouse - Oncopole Toulouse
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.
Eligibility Criteria
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)
Source: ClinicalTrials.gov (NCT07788430). StuddyBuddy aggregates publicly available trial information.