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

NCT04366219 | Unknown

• 1 other identifier: CHM-2020/S15/03
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

COVID; SARS-CoV 2; Lung Cancer

Keywords

Diagnostic management; Therapeutic management

Outcome Measures

Primary Outcomes (1)

• Comparison of clinical characteristics

  Comparison Group 2019 versus Group 2019

  At the end of the second period, i.e. on August 28, 2020

Secondary Outcomes (4)

• Comparison of diagnostic procedures

  At the end of the second period, i.e. on August 28, 2020

• Comparison of treatments (according to stage of disease)

  At the end of the second period, i.e. on August 28, 2020

• Comparison of patients management deadlines

  At the end of the second period, i.e. on August 28, 2020

• Comparison of survival

  After 2 years post diagnoses

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier le Mans: lead
• ONCO PAYS de la LOIRE: collaborator

Study Sites (1)

Centre Hospitalier Du Mans

Le Mans, 72000, France

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

CHRISTELLE JADEAU

CONTACT

+33 2 43 43 43 43; cjadeau@ch-lemans.fr

OLIVIER MOLINIER, MD

CONTACT

+33 2 43 43 43 43; omolinier@ch-lemans.fr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2020
• First Posted: April 28, 2020
• Study Start: December 1, 2021
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: July 28, 2022

Record last verified: 2022-03

Locations

FR (1)