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

Lung Cancer Clinical Trial

— CBP-COVID  

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04366219
• Other study ID #: CHM-2020/S15/03
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• COVID
• COVID-19
• Lung Cancer
• Lung Neoplasms
• SARS-CoV 2

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