RecruitingACTRN12623001105639

The host-microbiome in specialty patient populations

A multicentre prospective cohort study of the HOst-MIcrobiome interaction in SPECialty patient populations (HOMISPEC)


Sponsor

Royal Melbourne Hospital

Enrollment

768 participants

Start Date

Jun 15, 2021

Study Type

Observational

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria1

  • 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

Exclusion Criteria1

  • 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

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Interventions

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 le

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


Locations(3)

Austin Health - Austin Hospital - Heidelberg

VIC, Australia

Royal Melbourne Hospital - City campus - Parkville

VIC, Australia

Peter MacCallum Cancer Centre - Melbourne

VIC, Australia

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