Head and Neck CancerVADS-CovidNCT04704466
Impact of Covid-19 Pandemic on Management of Head and Neck Cancers
An observational study of Head and Neck Cancer and Covid19, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
Since its emergence in late December 2019, the SARS-CoV-2 coronavirus has spread rapidly, causing a global health crisis. The disease caused by this highly contagious respiratory virus is called COVID-19. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Covid19, Patient Care
- How many people
- 44 participants
- Where
- 1 siteFrance
- Study dates
- 7 Jan 2021to 1 Nov 2021
- 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: Patients undergoing maxillofacial surgery at the Amiens-Picardie University Hospital between March the 1st 2020 and February the 28th 2021, and in particular from those who have benefited from a multidisciplinary consultation meeting in H\&N oncology for treatment decisions during this period.
Who may be able to join
- patient diagnosed with cancer of the upper aero digestive tract
- patient benefiting from a medical consultation
- patient benefiting from a multidisciplinary consultation meeting for treatment decision between 01/03/2020 and 28/02/2021.
Who cannot join
- patient diagnosed with cancer other than upper aero digestive tract cancer
- patient whose treatment decision was made before 01/03/2020 (date considered as the beginning of the epidemic at the CHU Amiens-Picardie).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observational Study Evaluating the Impact of the Covid-19 Pandemic on the Management of Patients With Head and Neck Cancer in the Maxillofacial Surgery Department
Since its emergence in late December 2019, the SARS-CoV-2 coronavirus has spread rapidly, causing a global health crisis. The disease caused by this highly contagious respiratory virus is called COVID-19. At the beginning of August 2020, there were more than 194,000 confirmed cases in France - including approximately 16,000 cases in the Hauts-de-France area - and more than 30,300 deaths.
Cancer patients are generally susceptible to respiratory infections, and CoV-2-SARS is no exception. Early Chinese studies reported a higher rate of CoV-2-SARS infection in people with cancer (or a history of cancer) than in the general population, with more severe forms and with an increased risk if surgery or chemotherapy is performed in the month prior to infection. The purpose of this study is to describe the management modalities of patients with H\&N (Head and Neck) cancer during the COVID-19 pandemic in the Maxillofacial Surgery Department of CHU Amiens-Picardie.
- Conditions
- Head and Neck Cancer, Covid19, Patient Care
- Keywords
- Head and Neck Cancer, upper aero digestive tract cancer, Covid19, patient care
- Medical subject headings
- Head and Neck Neoplasms, COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation of delay (in days) between the first cancer consultation and the beginning of the first line of treatment
Variation of delay (in days) between the first cancer consultation and the beginning of the first line of treatment for patients with H\&N cancer during the COVID-19 pandemic in the Maxillofacial Surgery Department of CHU Amiens-Picardie.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2021
- Study start7 Jan 2021
- Primary completion1 Nov 2021
- Study completion1 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04704466
- Sponsor's protocol ID
- PI2021_843_0003
- Acronym
- VADS-Covid
- Status last verified
- Feb 2023
- First submitted
- 8 Jan 2021
- Last updated
- 10 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study Evaluating the Impact of the Covid-19 Pandemic on the Management of Patients With Head and Neck Cancer in the Maxillofacial Surgery Department
- ClinicalTrials.gov ID
- NCT04704466
- Acronym / sponsor ID
- VADS-Covid / PI2021_843_0003
- Conditions
- Head and Neck Cancer, Covid19, Patient Care
- Keywords
- Head and Neck Cancer, upper aero digestive tract cancer, Covid19, patient care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 7 Jan 2021 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 1 Nov 2021 (actual)
- First posted
- 11 Jan 2021 (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.
Since its emergence in late December 2019, the SARS-CoV-2 coronavirus has spread rapidly, causing a global health crisis. The disease caused by this highly contagious respiratory virus is called COVID-19. At the beginning of August 2020, there were more than 194,000 confirmed cases in France - including approximately 16,000 cases in the Hauts-de-France area - and more than 30,300 deaths.
Cancer patients are generally susceptible to respiratory infections, and CoV-2-SARS is no exception. Early Chinese studies reported a higher rate of CoV-2-SARS infection in people with cancer (or a history of cancer) than in the general population, with more severe forms and with an increased risk if surgery or chemotherapy is performed in the month prior to infection. The purpose of this study is to describe the management modalities of patients with H\&N (Head and Neck) cancer during the COVID-19 pandemic in the Maxillofacial Surgery Department of CHU Amiens-Picardie.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing maxillofacial surgery at the Amiens-Picardie University Hospital between March the 1st 2020 and February the 28th 2021, and in particular from those who have benefited from a multidisciplinary consultation meeting in H\&N oncology for treatment decisions during this period.
Key inclusion criteria (3 listed)
- patient diagnosed with cancer of the upper aero digestive tract
- patient benefiting from a medical consultation
- patient benefiting from a multidisciplinary consultation meeting for treatment decision between 01/03/2020 and 28/02/2021.
Key exclusion criteria (2 listed)
- patient diagnosed with cancer other than upper aero digestive tract cancer
- patient whose treatment decision was made before 01/03/2020 (date considered as the beginning of the epidemic at the CHU Amiens-Picardie).
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
Variation of delay (in days) between the first cancer consultation and the beginning of the first line of treatment
Time frame: 6 months
Variation of delay (in days) between the first cancer consultation and the beginning of the first line of treatment for patients with H\&N cancer during the COVID-19 pandemic in the Maxillofacial Surgery Department of CHU Amiens-Picardie.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Head and Neck Cancer and Covid19, run by Centre Hospitalier Universitaire, Amiens 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 2 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: finished, as of the sponsor's last update on 10 Feb 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variation of delay (in days) between the first cancer consultation and the beginning of the first line of treatment (time frame: 6 months). 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 10 Feb 2023.