Impact of Pesticide Exposure on Survival and Tumor Aggressiveness in Patients With Glioblastoma: A Prospective Clinical Study (EXPOGLIO)
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.
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Adèle MEOLA, MD
- Telefonní číslo: +33(0) 5 31 15 51 21
- E-mail: meola.adele@iuct-oncopole.fr
Studijní místa
-
-
-
Toulouse, Francie, 31059
- Institut Universitaire du Cancer de Toulouse - Oncopole
-
Kontakt:
- Adèle MEOLA, MD
- Telefonní číslo: +33(0) 5 31 15 51 21
- E-mail: meola.adele@iuct-oncopole.fr
-
Kontakt:
- Elizabeth COHEN-JONATHAN MOYAL, MD, PhD
- Telefonní číslo: +33 5 31 15 54 45
- E-mail: moyal.elizabeth@iuct-oncopole.fr
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
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)
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Výzkum zdravotnických služeb
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: Study assessments
The same study assessments will apply to all study participants
|
At the baseline visit, the following biological sample collection will be carried out:
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.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Progression-Free Survival (PFS)
Časové okno: 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.
|
through study completion, an average of 5 years
|
|
Pesticide Exposure
Časové okno: 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:
|
through study completion, an average of 5 years
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Overall Survival (OS)
Časové okno: through study completion, an average of 5 years
|
OS is defined as the time from inclusion to death from any cause.
At the time of analysis, patients alive will be censored at the date of last follow-up news.
|
through study completion, an average of 5 years
|
|
Pesticide Exposure
Časové okno: through study completion, an average of 5 years
|
Exposure to pesticides will be defined using the self-reported standardized questionnaire (derived from CERENAT study).
Three types of exposition will be defined (professional, environmental and domestic) and different metrics will be derived from the questionnaire (probability, intensity…).
|
through study completion, an average of 5 years
|
Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 26 TETE 02
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .