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Trial registered on ANZCTR


Registration number
ACTRN12621001307897
Ethics application status
Approved
Date submitted
6/09/2021
Date registered
27/09/2021
Date last updated
12/10/2021
Date data sharing statement initially provided
27/09/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
EVEREST: Evaluation of COVID-19 Vaccination Efficacy and Rare Events in Solid Tumours
Scientific title
Assessment of antibody response to COVID-19 vaccination in people with solid tumours
Secondary ID [1] 305235 0
Nil
Universal Trial Number (UTN)
Trial acronym
EVEREST
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer (solid tumour) 323513 0
Condition category
Condition code
Cancer 321074 321074 0 0
Any cancer

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
People with cancer are at increased risk of serious health outcomes from COVID-19 infection due to their underlying cancer and/or cancer treatment. Vaccination is the current best defence against severe illness from COVID-19. However, only a small number of people with cancer were included in initial clinical trials for COVID-19 vaccines.
This study is being conducted to better understand the immune response to vaccination in people with cancer, compared with the general population. The study is also aimed at assessing if people with cancer remain protected in the longer term. Any impact from cancer treatment on vaccine efficacy will be assessed.
Participants will have blood samples drawn at baseline prior to any COVID-19 vaccination, between their first and second dose of vaccination, then 1, 3 and 6 months following their second dose of COVID-19 vaccination. Approximately 8mL of blood will be collected in each session, taking approximately 15 minutes per session. Blood collection will be through ACT Pathology collection centres within The Canberra Region Cancer Centre (for patients) and The Canberra Hospital (for healthy controls). A study coordinator will assist in coordination of blood collection time-points. Baseline demographics on the study subjects, as well as characteristics of cancer type and treatment will be collected on the cancer patient cohort.
Administration of the COVID-19 vaccine itself will not be part of this study. Patients will receive vaccination at their usual GP clinic, pharmacy, or at one of the government vaccination centres, and then report adverse events and continue cancer care as per standard practice.
Intervention code [1] 321631 0
Not applicable
Comparator / control treatment
Healthy control subjects
Control group
Active

Outcomes
Primary outcome [1] 328855 0
Serological response post COVID-19 vaccination in people with cancer, as measured by the COVID-19 antibody level
Timepoint [1] 328855 0
Three months following second dose of COVID-19 vaccine
Primary outcome [2] 328856 0
Serological response post COVID-19 vaccination in healthy control subjects, as measured by the COVID-19 antibody level
Timepoint [2] 328856 0
Three months following second dose of COVID-19 vaccine
Secondary outcome [1] 400654 0
Serological response post COVID-19 vaccination in people with cancer as measured by the COVID-19 antibody level
Timepoint [1] 400654 0
baseline (pre vaccination)
one week prior second dose vaccine
one month post second dose vaccine
six months post second dose vaccine.
Secondary outcome [2] 400655 0
Serological response post COVID-19 vaccination in health control subjects as measured by the COVID-19 antibody level
Timepoint [2] 400655 0
baseline (pre vaccination)
one week prior second dose vaccine
one month post second dose vaccine
six months post second dose vaccine.

Eligibility
Key inclusion criteria
1. Planning to receive the COVID-19 vaccine or
received one dose of COVID-19 vaccine or
within 3 months of completion of COVID-19 vaccination (received two doses of the vaccine)
2. Recipients of either the Pfizer, AstraZeneca or Moderna COVID-19 vaccines
3. Cancer patient cohort: confirmed solid tumour malignancy and:
a. Receiving systemic cancer treatment: cytotoxic therapy, immunotherapy or targeted therapy within two weeks of at least one of the vaccine doses.
b. Targeted therapy includes and is not limited to tyrosine kinase inhibitors e.g. imatinib, cabozantinib, pazopanib, gefitinib, osimertinib; CDK4/6 inhibitors; BRAF/MEK inhibitors
c. Patients receiving hormonal therapy alone will not be eligible for the study.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Beyond 3 months following receipt of second dose of COVID-19 vaccination.
2. Past laboratory confirmed diagnosis of COVID-19 infection (such as nasopharyngeal RT-PCR swab). Routine screening for COVID-19 infection beyond requirements of the local health authority is not required.
3. Concurrent diagnosis of active haematological malignancy.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
6/09/2021
Date of last participant enrolment
Anticipated
6/09/2022
Actual
Date of last data collection
Anticipated
6/09/2023
Actual
Sample size
Target
200
Accrual to date
14
Final
Recruitment in Australia
Recruitment state(s)
ACT
Recruitment hospital [1] 20479 0
The Canberra Hospital - Garran
Recruitment postcode(s) [1] 35249 0
2605 - Garran

Funding & Sponsors
Funding source category [1] 309610 0
Charities/Societies/Foundations
Name [1] 309610 0
The Canberra Hospital Private Practice Fund
Country [1] 309610 0
Australia
Funding source category [2] 309612 0
Charities/Societies/Foundations
Name [2] 309612 0
John James Foundation
Country [2] 309612 0
Australia
Funding source category [3] 309634 0
Charities/Societies/Foundations
Name [3] 309634 0
Radiation Oncology Private Practice Fund
Country [3] 309634 0
Australia
Primary sponsor type
Hospital
Name
The Canberra Hospital
Address
Yamba Drive
Garran
ACT 2605
Country
Australia
Secondary sponsor category [1] 310627 0
None
Name [1] 310627 0
Address [1] 310627 0
Country [1] 310627 0
Other collaborator category [1] 281975 0
University
Name [1] 281975 0
Australian National University
Address [1] 281975 0
Canberra
ACT 0200
Country [1] 281975 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309385 0
ACT Health Human Reserch Ethics Committee
Ethics committee address [1] 309385 0
Ethics committee country [1] 309385 0
Australia
Date submitted for ethics approval [1] 309385 0
19/07/2021
Approval date [1] 309385 0
18/08/2021
Ethics approval number [1] 309385 0
2021.ETH.00062

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 113970 0
Dr Yada Kanjanapan
Address 113970 0
The Canberra Hospital
Yamba Drive
Garran ACT 2605
Country 113970 0
Australia
Phone 113970 0
+61 02 5124 8444
Fax 113970 0
+61 02 5124 4266
Email 113970 0
chs.everest@act.gov.au
Contact person for public queries
Name 113971 0
Sue Brew
Address 113971 0
Level 3 Building 6
The Canberra Hospital
Yamba Drive
Garran ACT 2605
Country 113971 0
Australia
Phone 113971 0
+61 02 5124 4338
Fax 113971 0
+61 02 5124 3645
Email 113971 0
sue.brew@act.gov.au
Contact person for scientific queries
Name 113972 0
Yada Kanjanapan
Address 113972 0
The Canberra Hospital
Yamba Drive
Garran ACT 2605
Country 113972 0
Australia
Phone 113972 0
+61 02 5124 8444
Fax 113972 0
+61 02 5124 4266
Email 113972 0
chs.everest@act.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
13112Ethical approval  sue.brew@act.gov.au



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.