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.
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Adèle MEOLA, MD
- 電話番号：+33(0) 5 31 15 51 21
- メール：meola.adele@iuct-oncopole.fr
研究場所
-
-
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Toulouse、フランス、31059
- Institut Universitaire du Cancer de Toulouse - Oncopole
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コンタクト：
- Adèle MEOLA, MD
- 電話番号：+33(0) 5 31 15 51 21
- メール：meola.adele@iuct-oncopole.fr
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コンタクト：
- Elizabeth COHEN-JONATHAN MOYAL, MD, PhD
- 電話番号：+33 5 31 15 54 45
- メール：moyal.elizabeth@iuct-oncopole.fr
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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)
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：ヘルスサービス研究
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Study assessments
The same study assessments will apply to all study participants
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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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Progression-Free Survival (PFS)
時間枠：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.
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through study completion, an average of 5 years
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Pesticide Exposure
時間枠：through study completion, an average of 5 years
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A patient is considered as exposed to pesticides if he meets at least one of the two following conditions:
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through study completion, an average of 5 years
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Overall Survival (OS)
時間枠：through study completion, an average of 5 years
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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.
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through study completion, an average of 5 years
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Pesticide Exposure
時間枠：through study completion, an average of 5 years
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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…).
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through study completion, an average of 5 years
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- 26 TETE 02
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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