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- Klinische proef 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.
Studie Overzicht
Toestand
Conditie
Studietype
Inschrijving (Verwacht)
Contacten en locaties
Studiecontact
- Naam: CHRISTELLE JADEAU
- Telefoonnummer: 37482 +33 2 43 43 43 43
- E-mail: cjadeau@ch-lemans.fr
Studie Contact Back-up
- Naam: OLIVIER MOLINIER, MD
- Telefoonnummer: +33 2 43 43 43 43
- E-mail: omolinier@ch-lemans.fr
Studie Locaties
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Le Mans, Frankrijk, 72000
- Werving
- Centre Hospitalier du Mans
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Hoofdonderzoeker:
- Olivier MOLINIER, MD
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
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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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Comparison of clinical characteristics
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Comparison of diagnostic procedures
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Medewerkers en onderzoekers
Sponsor
Medewerkers
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Coronavirus-infecties
- Coronaviridae-infecties
- Nidovirales-infecties
- RNA-virusinfecties
- Virusziekten
- Infecties
- Luchtweginfecties
- Ziekten van de luchtwegen
- Neoplasmata
- Longontsteking, viraal
- Longontsteking
- Longziekten
- Neoplasmata per site
- Neoplasmata van de luchtwegen
- Thoracale neoplasmata
- COVID-19
- Longneoplasmata
Andere studie-ID-nummers
- CHM-2020/S15/03
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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