- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.
Panoramica dello studio
Stato
Condizioni
Tipo di studio
Iscrizione (Anticipato)
Contatti e Sedi
Contatto studio
- Nome: CHRISTELLE JADEAU
- Numero di telefono: 37482 +33 2 43 43 43 43
- Email: cjadeau@ch-lemans.fr
Backup dei contatti dello studio
- Nome: OLIVIER MOLINIER, MD
- Numero di telefono: +33 2 43 43 43 43
- Email: omolinier@ch-lemans.fr
Luoghi di studio
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Le Mans, Francia, 72000
- Reclutamento
- Centre Hospitalier du Mans
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Investigatore principale:
- Olivier MOLINIER, MD
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
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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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Comparison of clinical characteristics
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Comparison of diagnostic procedures
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Sponsor
Collaboratori
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Infezioni da coronavirus
- Infezioni da Coronaviridae
- Infezioni da Nidovirus
- Infezioni da virus a RNA
- Malattie virali
- Infezioni
- Infezioni delle vie respiratorie
- Malattie delle vie respiratorie
- Neoplasie
- Polmonite, virale
- Polmonite
- Malattie polmonari
- Neoplasie per sede
- Neoplasie delle vie respiratorie
- Neoplasie toraciche
- COVID-19
- Neoplasie polmonari
Altri numeri di identificazione dello studio
- CHM-2020/S15/03
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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