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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

Sponsor
Centre Hospitalier le Mans (Other)
Overall Status
Recruiting
CT.gov ID
NCT04366219
Collaborator
ONCO PAYS de la LOIRE (Other)
2,000
Enrollment
1
Location
9
Anticipated Duration (Months)
222.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    2000 participants
    Observational Model:
    Other
    Time Perspective:
    Other
    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.
    Actual Study Start Date :
    Dec 1, 2021
    Anticipated Primary Completion Date :
    Sep 1, 2022
    Anticipated Study Completion Date :
    Sep 1, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Comparison of clinical characteristics [At the end of the second period, i.e. on August 28, 2020]

      Comparison Group 2019 versus Group 2019

    Secondary Outcome Measures

    1. Comparison of diagnostic procedures [At the end of the second period, i.e. on August 28, 2020]

      Comparison Group 2019 versus Group 2020

    2. Comparison of treatments (according to stage of disease) [At the end of the second period, i.e. on August 28, 2020]

      Comparison Group 2019 versus Group 2020

    3. Comparison of patients management deadlines [At the end of the second period, i.e. on August 28, 2020]

      Comparison Group 2019 versus Group 2020

    4. Comparison of survival [After 2 years post diagnoses]

      Comparison Group 2019 versus Group 2020

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Centre Hospitalier Du Mans Le Mans France 72000

    Sponsors and Collaborators

    • Centre Hospitalier le Mans
    • ONCO PAYS de la LOIRE

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Centre Hospitalier le Mans
    ClinicalTrials.gov Identifier:
    NCT04366219
    Other Study ID Numbers:
    • CHM-2020/S15/03
    First Posted:
    Apr 28, 2020
    Last Update Posted:
    Jul 28, 2022
    Last Verified:
    Mar 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Centre Hospitalier le Mans
    Diagnostic management
    Therapeutic management
    Additional relevant MeSH terms:
    COVID-19
    Lung Neoplasms

    Study Results

    No Results Posted as of Jul 28, 2022