NCT04632173

Brief Summary

To develop an International registry on head and neck cancer patients infected with COVID-19

Trial Health

47
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
750

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2021

Geographic Reach
3 countries

3 active sites

Status
unknown

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

First Submitted

Initial submission to the registry

November 15, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 17, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

May 3, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

March 17, 2022

Status Verified

March 1, 2022

Enrollment Period

1.2 years

First QC Date

November 15, 2020

Last Update Submit

March 16, 2022

Conditions

Head and Neck CancerCovid19

Outcome Measures

Primary Outcomes (7)

  • Demographic features

    age, performance status etc

    Nov 1 2019 to January 31 2021

  • prevalence of comorbidities in head and neck cancer patients with COVID-19

    Nov 1 2019 to January 31 2021

  • proportion of head and neck cancer patients experiencing severe adverse events

    Nov 1 2019 to January 31 2021

  • proportion of head and neck cancer patients by COVID-19 clinical course severity

    Nov 1 2019 to January 31 2021

  • proportion of head and neck cancer patients with COVID-19 who received chemotherapy, surgery, radiotherapy, immune check point inhibitors in the last 3 months before, as well as during, COVID-19 infection

    Nov 1 2019 to January 31 2021

  • predictive factors of severe adverse events in head and neck cancer patients with COVID-19 including cancer-related treatment

    Nov 1 2019 to January 31 2021

  • prognostic factors of head and neck cancer patients with COVID-19 including cancer related treatment including Human papilloma virus(HPV).

    Nov 1 2019 to January 31 2021

Interventions

non interventional studyOTHER

There is no intervention

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This is a longitudinal multi-centre study on head and neck cancer patients (any age, sex, histology, stage, in active treatment as well as in clinical follow-up) who contract COVID-19. Information on clinical features, clinical course, management and outcomes will be collected for both, head and neck cancers and COVID-19 infection. Considering the limited data available about COVID-19 evolution, the sample size will be not anticipated. However, with about 150 centers and a median of 5 patients at every center, a sample size of 750 patients approximately can produce a confidence interval for the categorical estimate of +/-2%. Clinical data will be extracted from medical records of consecutive patients from November 1st, 2019 until January 31 2021.

You may qualify if:

  • Any head and neck cancer patients (including salivary gland, thyroid, nasal and paranasal cancer with a COVID-19 diagnosis defined as any of the following:
  • Laboratory confirmed \[Real Time - Polymerase Chain Reaction (RT-PCR) technique\] COVID-19.
  • Suspected COVID-19 cases; diagnosed clinically based on symptoms (fever \>37.5°, decrease of oximeter saturation of at least 5 %, cough, diarrhoea, otitis, dysgeusia, anosmia, myalgia, arthralgia, conjunctivitis and rhinorrhea and exposure to confirmed COVID-19 positive case (laboratory confirmation).
  • Clinically diagnosed cases; suspected cases with lung imaging features consistent with coronavirus pneumonia.
  • Asymptomatic cases; diagnosed based on positive viral nucleic acid test results but without any COVID- 19 symptoms

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

"Attikon" University Hospital

Chaïdári, Athens, 12462, Greece

RECRUITING

Lisa Licitra

Milan, 20133, Italy

RECRUITING

National Cancer Centre (NCC)- Radiation Oncology Dept

Singapore, 169610, Singapore

RECRUITING

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 Officials

  • Evita Fragou

    HeCOG

    STUDY DIRECTOR

Central Study Contacts

Amanda Psyrri, MD

CONTACT

+302105831664psyrri237@yahoo.com

Lisa Licitra, MD

CONTACT

lisa.licitra@istitutotumori.mi.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medical Oncology

Study Record Dates

First Submitted

November 15, 2020

First Posted

November 17, 2020

Study Start

May 3, 2021

Primary Completion

June 30, 2022

Study Completion

December 30, 2022

Last Updated

March 17, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

GR(1)IT(1)SG(1)