Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001105639
Ethics application status
Approved
Date submitted
20/09/2023
Date registered
20/10/2023
Date last updated
20/10/2023
Date data sharing statement initially provided
20/10/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
The host-microbiome in specialty patient populations
Scientific title
A multicentre prospective cohort study of the HOst-MIcrobiome interaction in SPECialty patient populations (HOMISPEC)
Secondary ID [1] 310652 0
Nil known
Universal Trial Number (UTN)
Trial acronym
HOMISPEC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Immunecompromised 331534 0
End stage liver disease 331535 0
Liver transplant 331536 0
Leukemia 331537 0
allogeneic stem cell transplant 331538 0
Condition category
Condition code
Infection 328275 328275 0 0
Studies of infection and infectious agents
Cancer 328276 328276 0 0
Any cancer
Inflammatory and Immune System 328461 328461 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 328462 328462 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is a multicentre, prospective observational cohort study across three centres in Melbourne, Victoria, Australia. Participants will be recruited across the following clinical streams; (1) acute leukaemia and allogeneic stem cell transplant; (2) end stage liver disease and liver transplant; (3) receiving cancer immunotherapies; (4) deceased organ donors and (5) healthy adult controls. Participants will provide paired peripheral blood and microbiota samples (stool and saliva) at either a) single time point for healthy controls and deceased organ donors or b) longitudinally over multiple time points for the remaining cohorts (Pre transplant, weekly for 4 weeks post transplant then 3 monthly up to 2 years). Additional event driven sampling from bronchoalveolar lavage, colonoscopy and biopsy of tissues undertaken during routine care will also be procured at the time of infection or rejection event. Samples will be collected during hospitalisation or at home and returned via Express post if the participant is not otherwise attending a routine scheduled outpatient visit at the time of sample collection. Participants will be followed up for 2 years after transplant or cancer therapy or until death
Intervention code [1] 327055 0
Not applicable
Comparator / control treatment
Healthy adult controls
Control group
Active

Outcomes
Primary outcome [1] 336132 0
First infection which is a composite of either cinicall or microbioloigcally defined infection
Timepoint [1] 336132 0
Outcome will be asessed 6 monthly for up to 2 years post transplant or cancer immune therapy
Secondary outcome [1] 426961 0
First immune event which is a composite of either graft versus host disease (GVHD) or allograft rejection
Timepoint [1] 426961 0
Outcome will be asessed 6 monthly for up to 2 years post transplant or cancer immune therapy

Eligibility
Key inclusion criteria
Adults greater than or equal to 18 years of age with acute leukemia undergoing induction/consolidation chemotherapy +/- planned for allogeneic stem cell transplant OR receiving cellular or immune based therapies OR waitlisted for liver transplant for end stage liver disease willing and able to provide informed consent or with a medical decision maker able to provide consent OR healthy controls
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants will be excluded if (1) age less than 18 years; (2) either they or their medical treatment decision maker are unable or unwilling to provide written and informed consent

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
15/06/2021
Date of last participant enrolment
Anticipated
1/06/2026
Actual
Date of last data collection
Anticipated
1/06/2028
Actual
Sample size
Target
216
Accrual to date
180
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 25569 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [2] 25570 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [3] 25571 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 41390 0
3084 - Heidelberg
Recruitment postcode(s) [2] 41391 0
3050 - Parkville
Recruitment postcode(s) [3] 41392 0
3000 - Melbourne

Funding & Sponsors
Funding source category [1] 314865 0
Government body
Name [1] 314865 0
National Health and Medical Research Council
Country [1] 314865 0
Australia
Funding source category [2] 314985 0
Hospital
Name [2] 314985 0
Austin Health
Country [2] 314985 0
Australia
Funding source category [3] 314986 0
Hospital
Name [3] 314986 0
Peter MacCallum Cancer Center
Country [3] 314986 0
Australia
Primary sponsor type
Hospital
Name
Royal Melbourne Hospital
Address
300 Grattan Street, Parkville, VIC, 3050
Country
Australia
Secondary sponsor category [1] 316861 0
None
Name [1] 316861 0
Address [1] 316861 0
Country [1] 316861 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313866 0
The Royal Melbourne Hospital Human Research Ethics Committee
Ethics committee address [1] 313866 0
300 Grattan St, Parkville VIC 3050
Ethics committee country [1] 313866 0
Australia
Date submitted for ethics approval [1] 313866 0
19/02/2021
Approval date [1] 313866 0
22/03/2021
Ethics approval number [1] 313866 0

Summary
Brief summary
This is a multicentre, prospective observational cohort study across three centres in Melbourne, Victoria, Australia examining differences in the microbiota of people with leukaemia, people with liver disease, people with other types of cancer who are receiving immunotherapy and healthy volunteers.

Who is it for?
You may be eligible for this study if you are an adult aged 18 years or older and you are either:
a) a healthy volunteer who has not been diagnosed with cancer or liver disease, or
b) someone who has been diagnosed with acute leukaemia who has or has not received an allogeneic stem cell transplant, or
c) someone who has end stage liver disease and has received a liver transplant, or
d) someone who has another type of cancer who is receiving an immunotherapy treatment.

Study details
Participants who fall into one of the health conditions described above who choose to enrol in this study will be asked to provide a series of blood, stool (faeces) and saliva samples weekly for initial hospital duration then 3 monthly for up to 2 years after enrolment.
Participants who are healthy volunteers will be asked to provide a once off blood, stool and saliva sample at the time of enrolment.

It is hoped this research will determine whether there are any differences in the diversity of microbiota in people who are immunocompromised compared to healthy volunteers, and whether the type of microbiota that a person hosts has an impact on their susceptability to infection.
Trial website
Trial related presentations / publications
Public notes
Deceased organ donor stool samples will be compared with the stool samples of transplant recipients for similarities in diversity and composition

Contacts
Principal investigator
Name 129606 0
Prof Monica Slavin
Address 129606 0
Peter MacCallum Cancer Center, 305 Grattan St, Melbourne VIC 3052
Country 129606 0
Australia
Phone 129606 0
+61 3 8559 5000
Fax 129606 0
Email 129606 0
[email protected]
Contact person for public queries
Name 129607 0
Dr Olivia Smibert
Address 129607 0
Peter MacCallum Cancer Center, 305 Grattan St, Melbourne VIC 3052
Country 129607 0
Australia
Phone 129607 0
+61 3 8559 5000
Fax 129607 0
Email 129607 0
[email protected]
Contact person for scientific queries
Name 129608 0
Dr Olivia Smibert
Address 129608 0
Peter MacCallum Cancer Center, 305 Grattan St, Melbourne VIC 3052
Country 129608 0
Australia
Phone 129608 0
+61 3 8559 5000
Fax 129608 0
Email 129608 0
[email protected]

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?

No Supporting Document Provided



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.