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Australian Clinical Trials

Clinical Trial Details

The SerOzNET study seeks to better understand the safety and efficacy of the COVID-19 vaccines in people with cancer.

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Trial Information

Broad Health Condition Cancer
Cancer
Cancer
Cancer
Cancer

Specific Health ConditionAny cancer
Leukaemia - Chronic leukaemia
Myeloma
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Children's - Leukaemia & Lymphoma

Trial Focus

Recruitment Details

Recruitment status
Recruiting

Recruitment State
NSW,WA,VIC

Hospital
Monash Medical Centre - Clayton campus - Clayton
Monash Medical Centre - Moorabbin campus - East Bentleigh
Dandenong Hospital - Dandenong
Casey Hospital - Berwick
Sydney Children's Hospital - Randwick
The Children's Hospital at Westmead - Westmead
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Royal Perth Hospital - Perth

Postcode
3168 - Clayton
3165 - East Bentleigh
3175 - Dandenong
3806 - Berwick
2031 - Randwick
2145 - Westmead
2010 - Darlinghurst
6000 - Perth

Anticipated date of last participant enrolment30/12/2022

Phase of TrialNot Applicable

Has the study received ethics approval?Further information iconApproved

Trial summary

This study will investigate the serological and immune response of cancer patients to the COVID-19 vaccine

Who is it for?
You may be eligible to join this study if you are aged 5 and above, have not received COVID-19 vaccination, with one or more of the following criteria:

 •	Currently on chemotherapy
•	Currently on immunotherapy
•	Currently on hormonal therapy
•	Received chemotherapy 6-12 months ago
•	Have an allergy to either a vaccine or an anticancer treatment
•	Have a diagnosis of multiple myeloma, CLL, or low grade lymphoma,
        are eligible for government COVID-19 vaccination program and willing to receive the 
        vaccine

Study details
All participants in this study will have serial sampling of blood and collection of data from “qualitative studies” (patient-reported adverse events, quality of life, common data elements (CDE), and vaccine hesitancy; together with post-hoc toxicity reporting) at baseline, day 7 post initial vaccination, at booster appointment, 7 days post booster and at 3 months after booster vaccination.

Administration of the vaccine itself and real-time collection/assessment/management of toxicities will not form part of the SerOzNET study. Patients will receive vaccination at their usual GP clinic or at one of the government vaccination centres, and then report adverse events and continue cancer care as per standard practice.

It is hoped this research will contribute to the cancer immunology field in order to assist oncologist improve health outcomes for patients with cancer.

The study involves serial sampling of blood and collection of data from “qualitative studies” (patient-reported adverse events, quality of life, common data elements (CDE), and vaccine hesitancy; together with post-hoc toxicity reporting).

Eligibility

Key inclusion criteria

 Aged 5 years or over as per ATAGI guidelines for COVID-19 vaccination (January 10, 2022)
• Able to give informed consent (parent/guardian for participants < 16 years)
• Eligible for government COVID-19 vaccination program and willing to receive the
vaccine
• Cancer diagnosis fitting one of the study cohorts (solid tumour, haematological
malignancy, currently receiving chemotherapy, currently receiving immunotherapy &
known allergic reaction to PEG or Polysorbate)

Minimum age5 Years

GenderBoth males and females

Can Healthy volunteers participate? No

Key exclusion criteria

•	Not appropriate for serial peripheral blood collections, due to clinical reasons such as 
        severe anaemia, poor venous access or other, as determined by the patient’s  
        oncologist or haematologist.
•	Life expectancy estimated to be greater than 12 months
•	Individual is not able to provide informed consent
•	Pregnancy
Contact details and further information

Sponsor Primary Sponsor Type: Hospital
Primary Sponsor Name: Monash Health
Primary Sponsor Address: 246 Clayton Road Clayton VIC 3168
Primary Sponsor Country: Australia

Trial websitehttps://www.canceraustralia.gov.au/SerOzNET-Study

Trial IDACTRN12621001004853

Contact person for information and recruitmentMs
Luxi Lal
Monash Health MHTP Clinical Trial Centre 246 Clayton Rd Clayton VIC 3168
+61428803521
+6139594 3982

Email contact Further information iconseroznet@monashhealth.org

Australia