Genetic Predisposition to Breast and Ovarian Cancer: Prospective Study of BRCAx Gene Mutation (GENEPSO)
2020年6月30日 更新者：Institut Paoli-Calmettes
Cohort of subjects carrying a BRCA gene mutation: genetic predispositions to breast and ovarian cancers
調査の概要
詳細な説明
Cohort of subjects carrying a BRCA gene mutation: genetic predispositions to breast and ovarian cancers
研究の種類
観察的
入学 (予想される)
5000
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Dominique GENRE, MD
- 電話番号：33 491 22 37 78
- メール：DRCI.UP@ipc.unicancer.fr
研究連絡先のバックアップ
- 名前：Margot BERLINE, MSc, MBA
- 電話番号：33 491 22 33 14
- メール：DRCI.UP@ipc.unicancer.fr
研究場所
-
-
-
Marseille、フランス、13009
- 募集
- Institut Paoli-Calmettes
-
コンタクト：
- Catherine NOGUES, MD
- 電話番号：334 91 223395
- メール：NOGUESC@ipc.unicancer.fr
-
主任研究者：
- Catherine NOGUES, MD
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
サンプリング方法
非確率サンプル
調査対象母集団
women and men with a BRCA1 or BRCA2 mutation
説明
Woman or man, with or without cancer, carrying a deleterious BRCA1/BRCA2 mutation, aged 18 years and over.
- Woman with or without breast cancer or ovarian cancer at baseline.
- Man with or without breast cancer at baseline.
- Signed consent to participation
- Affiliation to a social security regimen, or beneficiary of such a regimen.
Exclusion Criteria:
- A person of legal age subject to a legal protection measure, or unable to express consent.
- Impossibility to submit to the follow-up of the test for geographical, social or psychological reasons
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：コホート
- 時間の展望：見込みのある
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
subjects carrying a BRCA gene mutation
|
standardized data collection and 10-year prospective follow-up
|
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 |
|---|---|---|
|
Incidence of breast and / or ovarian cancer during subject lifetime
時間枠：10 years
|
risk that a subject with a mutation develops breast and / or ovarian cancer during his lifetime, assessed by epidemiologic questionnaires (carcinologic events).
|
10 years
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Catherine NOGUES, MD、Institut Paoli-Calmettes
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
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研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
1999年10月15日
一次修了 (予想される)
2028年10月15日
研究の完了 (予想される)
2028年10月15日
試験登録日
最初に提出
2018年9月10日
QC基準を満たした最初の提出物
2018年9月11日
最初の投稿 (実際)
2018年9月12日
学習記録の更新
投稿された最後の更新 (実際)
2020年7月1日
QC基準を満たした最後の更新が送信されました
2020年6月30日
最終確認日
2020年6月1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
- GENEPSO-IPC 2018-031
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
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
いいえ
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。