- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT04366219
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.
Aperçu de l'étude
Statut
Les conditions
Type d'étude
Inscription (Anticipé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: CHRISTELLE JADEAU
- Numéro de téléphone: 37482 +33 2 43 43 43 43
- E-mail: cjadeau@ch-lemans.fr
Sauvegarde des contacts de l'étude
- Nom: OLIVIER MOLINIER, MD
- Numéro de téléphone: +33 2 43 43 43 43
- E-mail: omolinier@ch-lemans.fr
Lieux d'étude
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Le Mans, France, 72000
- Recrutement
- Centre Hospitalier Du Mans
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Chercheur principal:
- Olivier MOLINIER, MD
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Comparison of clinical characteristics
Délai: At the end of the second period, i.e. on August 28, 2020
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Comparison Group 2019 versus Group 2019
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At the end of the second period, i.e. on August 28, 2020
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Comparison of diagnostic procedures
Délai: At the end of the second period, i.e. on August 28, 2020
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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 treatments (according to stage of disease)
Délai: At the end of the second period, i.e. on August 28, 2020
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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
Délai: At the end of the second period, i.e. on August 28, 2020
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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 survival
Délai: After 2 years post diagnoses
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Comparison Group 2019 versus Group 2020
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After 2 years post diagnoses
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Infections à coronavirus
- Infections à Coronaviridae
- Infections à Nidovirales
- Infections par virus à ARN
- Maladies virales
- Infections
- Infections des voies respiratoires
- Maladies des voies respiratoires
- Tumeurs
- Pneumonie virale
- Pneumonie
- Maladies pulmonaires
- Tumeurs par site
- Tumeurs des voies respiratoires
- Tumeurs thoraciques
- COVID-19 [feminine]
- Tumeurs pulmonaires
Autres numéros d'identification d'étude
- CHM-2020/S15/03
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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