The Surveillance, Epidemiology, and End Results Database Program on Endometrial Cancer in the Italian Population (ENDOCancerDATA)
The ENDOCancer-DATA: the Surveillance, Epidemiology, and End Results Database Program on Endometrial Cancer in the Italian Population
調査の概要
詳細な説明
Endometrial cancer represents the most common gynecological cancer in industrialized countries and the fourth most common neoplasm after breast, lung and colorectal cancer. Unlike other neoplasms, its incidence and mortality are continuously increasing. In this context, the National Health System requires an optimization of the diagnosis and treatment strategies of this carcinoma. This aspect leads a continuous effort to improve to properly manage the impact that this disease has on female health in Italy. Throughout the world, there are national, supranational models and registers aimed at establishing and managing over time an archive of all newly diagnosed cancer cases, ensuring that data recording takes place in a rigorous, continuous and systematic manner. An excellent example of this is the SEER of the National Cancer Institute of America, which has the task of recording and monitoring the epidemiological-clinical data of various carcinomas, to monitor the clinical progress and management of therapeutic programs of neoplastic pathologies. This program represents the epidemiological and statistical basis of important scientific evidence, both prospective and retrospective, aimed at reporting and demonstrating the effectiveness of preventive, diagnostic and therapeutic approaches in the various oncological pathologies examined.
On these premises, the aim of this study is to lay the bases for an ambitious project that reports and records all the epidemiological-clinical information of the cases of endometrial carcinoma diagnosed and treated in the reference oncology centers involved on the national territory, to create a process of analysis of the data
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前:Francesco Fanfani, MD
- 電話番号:+390630133421
- メール:francesco.fanfani@policlinicogemelli.it
研究場所
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Roma、イタリア、00136
- 募集
- Fondazione Policlinico Universitario Agostino Gemelli, IRCCS
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コンタクト:
- Francesco Fanfani, MD
- 電話番号:0630153421
- メール:francesco.fanfani@policlinicogemelli.it
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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
サンプリング方法
調査対象母集団
All patients undergoing staging and cytoreduction surgery for endometrial cancer will be included in the study.
This database will make use of data collected retrospectively with prospectively continuously updated prognostic and clinical information.
The following data will be collected: clinical characteristics (age, BMI, ASA, previous tumors), histopathological data (histotype, grade, FIGO stage, etc.) Furthermore, data will be collected relating to the adjuvant chemotherapy or radiotherapy treatment performed, survival outcome (DFS and OS), number of relapses and deaths, type of relapse, treatment at relapse, cause of death.
説明
Inclusion Criteria:
- diagnosis of endometrial cancer (stage I-IV, G1-3, and special histotypes)
- age > 18 years
- American Society of Anesthesiologists classification (ASA score) 1-3
- patients undergoing staging, cytoreduction or diagnostic surgery with acquisition of histological examination on which IHC and/or NGS studies have been performed for the molecular profile of the carcinoma
- Signed informed consent
Exclusion Criteria:
- patients with missing information
- patients not treated in the participating centers for which only partial and fragmented information will be available
- molecular profile not known and\or not recoverable and retrospectively analysable
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
コホートと介入
グループ/コホート |
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Endometrial cancer patients
All patients undergoing staging and cytoreduction surgery for endometrial cancer
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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 |
|---|---|---|
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Disease Free Survival
時間枠:Baseline.
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To evaluate the impact of the immuno-molecular and clinical profile of endometrial cancer on the outcomes of DFS (Disease-Free Survival).
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Baseline.
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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
時間枠:Baseline.
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To evaluate the impact of the immuno-molecular and clinical profile of endometrial cancer on the outcomes of OS (overall survival).
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Baseline.
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協力者と研究者
捜査官
- 主任研究者:Francesco Fanfani、Fondazione Policlinico Universitario Agostino Gemelli IRCCS
研究記録日
主要日程の研究
研究開始 (実際)
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
- 6168
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?
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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