COVIDCBP-COVIDNCT04366219
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 observational study of COVID and SARS-CoV 2, run by Centre Hospitalier le Mans at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID, SARS-CoV 2, Lung Cancer
- How many people
- 2,000 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2021to Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier Du Mans
Le Mans, 72000
Christelle JADEAU, +33244710781, cjadeau@ch-lemans.fr
Olivier MOLINIER, MD
About this study
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.
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
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Comparison of clinical characteristics
Comparison Group 2019 versus Group 2019
Measured: At the end of the second period, i.e. on August 28, 2020
Secondary outcomes (4)
Comparison of diagnostic procedures
Comparison Group 2019 versus Group 2020
Measured: 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
Measured: At the end of the second period, i.e. on August 28, 2020
Comparison of patients management deadlines
Comparison Group 2019 versus Group 2020
Measured: At the end of the second period, i.e. on August 28, 2020
Comparison of survival
Comparison Group 2019 versus Group 2020
Measured: After 2 years post diagnoses
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2020
- Study start1 Dec 2021
- Primary completionSep 2022 (estimated)
- Study completionSep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVIDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier le Mans
- Sponsor type
- University, hospital or other
- Collaborators
- ONCO PAYS de la LOIRE
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04366219
- Sponsor's protocol ID
- CHM-2020/S15/03
- Acronym
- CBP-COVID
- Status last verified
- Mar 2022
- First submitted
- 27 Apr 2020
- Last updated
- 28 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04366219
- Acronym / sponsor ID
- CBP-COVID / CHM-2020/S15/03
- Conditions
- COVID, SARS-CoV 2, Lung Cancer
- Keywords
- Diagnostic management, Therapeutic management
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Centre Hospitalier le MansUniversity, hospital or other
- Collaborators
- ONCO PAYS de la LOIRE
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 28 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Comparison of clinical characteristics
Time frame: At the end of the second period, i.e. on August 28, 2020
Comparison Group 2019 versus Group 2019
4 secondary outcomes
Comparison of diagnostic procedures
Time frame: At the end of the second period, i.e. on August 28, 2020
Comparison of treatments (according to stage of disease)
Time frame: At the end of the second period, i.e. on August 28, 2020
Comparison of patients management deadlines
Time frame: At the end of the second period, i.e. on August 28, 2020
Comparison of survival
Time frame: After 2 years post diagnoses
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID and SARS-CoV 2, run by Centre Hospitalier le Mans at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact CHRISTELLE JADEAU (+33 2 43 43 43 43 ext. 37482, cjadeau@ch-lemans.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of clinical characteristics (time frame: At the end of the second period, i.e. on August 28, 2020). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2022.