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.

Study Overview

• Status: Recruiting
• Conditions: SARS-CoV 2; Lung Cancer; COVID

• Study Type: Observational
• Enrollment (Anticipated): 2000

Contacts and Locations

• Study Contact: Name: CHRISTELLE JADEAU; Phone Number: 37482 +33 2 43 43 43 43; Email: cjadeau@ch-lemans.fr
• Study Contact Backup: Name: OLIVIER MOLINIER, MD; Phone Number: +33 2 43 43 43 43; Email: omolinier@ch-lemans.fr

Study Locations

• France
  • Le Mans, France, 72000
    • Recruiting
    • Centre Hospitalier du Mans
    • Principal Investigator: Olivier MOLINIER, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Group 2019: Patient diagnosed with lung cancer from March 13, 2019 until August 28, 2019 Group 2020: Patient diagnosed with lung cancer from March 13, 2020 until August 28, 2020

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
2019; Data collection on patients with Lung cancer diagnosed between March 13, 2019 and August 28, 2019.
2020; Data collection on patients with Lung cancer diagnosed between March 13, 2020 and August 28, 2020.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of clinical characteristics	Comparison Group 2019 versus Group 2019	At the end of the second period, i.e. on August 28, 2020

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of diagnostic procedures	Comparison Group 2019 versus Group 2020	At the end of the second period, i.e. on August 28, 2020
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
Comparison of patients management deadlines	Comparison Group 2019 versus Group 2020	At the end of the second period, i.e. on August 28, 2020
Comparison of survival	Comparison Group 2019 versus Group 2020	After 2 years post diagnoses

Collaborators and Investigators

• Sponsor: Centre Hospitalier le Mans
• Collaborators: ONCO PAYS de la LOIRE

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Anticipated): September 1, 2022
• Study Completion (Anticipated): September 1, 2022

Study Registration Dates

• First Submitted: April 27, 2020
• First Submitted That Met QC Criteria: April 27, 2020
• First Posted (Actual): April 28, 2020

Study Record Updates

• Last Update Posted (Actual): July 28, 2022
• Last Update Submitted That Met QC Criteria: July 27, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Diagnostic management; Therapeutic management
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Neoplasms; Pneumonia, Viral; Pneumonia; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; COVID-19; Lung Neoplasms
• Other Study ID Numbers: CHM-2020/S15/03

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No