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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04366219
Other study ID # CHM-2020/S15/03
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 1, 2021
Est. completion date September 2022

Study information

Verified date March 2022
Source Centre Hospitalier le Mans
Contact CHRISTELLE JADEAU
Phone +33 2 43 43 43 43
Email cjadeau@ch-lemans.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 2000
Est. completion date September 2022
Est. primary completion date September 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Centre Hospitalier Du Mans Le Mans

Sponsors (2)

Lead Sponsor Collaborator
Centre Hospitalier le Mans ONCO PAYS de la LOIRE

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Comparison of clinical characteristics Comparison Group 2019 versus Group 2019 At the end of the second period, i.e. on August 28, 2020
Secondary Comparison of diagnostic procedures Comparison Group 2019 versus Group 2020 At the end of the second period, i.e. on August 28, 2020
Secondary Comparison of treatments (according to stage of disease) Comparison Group 2019 versus Group 2020 At the end of the second period, i.e. on August 28, 2020
Secondary Comparison of patients management deadlines Comparison Group 2019 versus Group 2020 At the end of the second period, i.e. on August 28, 2020
Secondary Comparison of survival Comparison Group 2019 versus Group 2020 After 2 years post diagnoses
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