Impact of Confinement and Preventive Measures in Period of SARS-COV2 Infection on Clinical Features, Diagnostic and Therapeutic Management and Prognosis of Patients With Lung Cancer (CBP-COVID)
Impact of Confinement and Preventive Measures in Period of SARS-COV2 Infection on Clinical Features, Diagnostic and Therapeutic Management and Prognosis of Patients With Lung Cancer: an Ambispective Study Extended Over 2 Time Periods.
The unexpected onset of SARS-COV2 infection modified our practices, especially in routine medicine. In order to reverse the epidemic curve of severe cases and slow the spread of the infection, confinement was generalized in France from March 13, 2020.These restrictive measures were imposed on anyone with symptoms compatible with the infection, with the exception of dyspnea and other criteria of severity. March 12, 2020 is the pivotal date when the management of COVID came to interfere with medical and healthcare organizations. From this date, it is likely that some imaging or endoscopic exams have been de-scheduled for symptoms that are sometimes wrongly judged to be non-urgent and have seen their numbers drop dramatically.Otherwise, concerning lung cancer, preventive measures have been extremely strengthened. For instance, it is recommended to delay surgeries for localized tumors, to relieve or remove some chemotherapy or to delete radiotherapy sessions deemed non-essential. However, symptoms that may initially be attributed to viral infection, such as cough, fever, fatigue, or chest pain may be clinical indicators of early-stage Lung cancer. In addition, lung cancer is likely to make the patient more susceptible to pneumopathy, due to a weakened of immune response to viruses and bacteria. Consequently, as necessary as the restriction measures are, a risk of slowing down in the management of the Lung cancer pathology exists.
The CBP-COVID Study intends to assess consequences of restrictive measures linked to the SARS-COV2 epidemic, by comparing clinical characteristics at diagnosis, treatment times and treatments, regarding to 2 distinct time periods identical to the calendar, but one in 2019, the other in 2020.
調査の概要
状態
条件
研究の種類
入学 (予想される)
連絡先と場所
研究連絡先
- 名前:CHRISTELLE JADEAU
- 電話番号:37482 +33 2 43 43 43 43
- メール:cjadeau@ch-lemans.fr
研究連絡先のバックアップ
- 名前:OLIVIER MOLINIER, MD
- 電話番号:+33 2 43 43 43 43
- メール:omolinier@ch-lemans.fr
研究場所
-
-
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Le Mans、フランス、72000
- 募集
- Centre Hospitalier du Mans
-
主任研究者:
- Olivier MOLINIER, MD
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Patient newly diagnosed with a lung cancer based on histological or cytological criteria.
- Patient followed by investigating site participating in the study.
- Patient informed verbally and by an information document specifying the interest of the study and having given his oral agreement for the participation for the prospective part of the study.
Exclusion Criteria:
- Patient investigated and / or monitored in a site not involved in the study.
- Patient with lung cancer of incidental finding during hospitalization for another reason.
- Patient with recurrence of a previoulsy known lung cancer.
- Patient included in a clinical research trial.
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 |
---|
2019
Data collection on patients with Lung cancer diagnosed between March 13, 2019 and August 28, 2019.
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2020
Data collection on patients with Lung cancer diagnosed between March 13, 2020 and August 28, 2020.
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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 |
---|---|---|
Comparison of clinical characteristics
時間枠:At the end of the second period, i.e. on August 28, 2020
|
Comparison Group 2019 versus Group 2019
|
At the end of the second period, i.e. on August 28, 2020
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Comparison of diagnostic procedures
時間枠:At the end of the second period, i.e. on August 28, 2020
|
Comparison Group 2019 versus Group 2020
|
At the end of the second period, i.e. on August 28, 2020
|
Comparison of treatments (according to stage of disease)
時間枠:At the end of the second period, i.e. on August 28, 2020
|
Comparison Group 2019 versus Group 2020
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At the end of the second period, i.e. on August 28, 2020
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Comparison of patients management deadlines
時間枠:At the end of the second period, i.e. on August 28, 2020
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Comparison Group 2019 versus Group 2020
|
At the end of the second period, i.e. on August 28, 2020
|
Comparison of survival
時間枠:After 2 years post diagnoses
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Comparison Group 2019 versus Group 2020
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After 2 years post diagnoses
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
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
追加の関連 MeSH 用語
その他の研究ID番号
- CHM-2020/S15/03
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
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。
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