NCT04704466

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 7, 2021

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

January 8, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 11, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2021

Completed
Last Updated

February 10, 2023

Status Verified

February 1, 2023

Enrollment Period

10 months

First QC Date

January 8, 2021

Last Update Submit

February 9, 2023

Conditions

Keywords

Head and Neck Cancerupper aero digestive tract cancerCovid19patient care

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens

Amiens, 80480, France

Location

MeSH Terms

Conditions

Head and Neck NeoplasmsCOVID-19

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2021

First Posted

January 11, 2021

Study Start

January 7, 2021

Primary Completion

November 1, 2021

Study Completion

November 1, 2021

Last Updated

February 10, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations