Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000374460
Ethics application status
Approved
Date submitted
26/03/2025
Date registered
28/04/2025
Date last updated
28/04/2025
Date data sharing statement initially provided
28/04/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Microbiome in Transplant and Cellular Therapy Outcomes.
Scientific title
Gastrointestinal microbiome influences health outcomes in patients undergoing Transplantation and Cellular Therapy.
Secondary ID [1] 313886 0
None
Universal Trial Number (UTN)
Trial acronym
micro TCT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Graft-Versus-Host-Disease (GVHD) 336554 0
Gastrointestinal (GI) microbiome interaction post-therapy/transplant 336555 0
Antimicrobial Resistance (AMR) 336556 0
Immune system function 336557 0
Condition category
Condition code
Inflammatory and Immune System 333070 333070 0 0
Normal development and function of the immune system
Inflammatory and Immune System 333071 333071 0 0
Autoimmune diseases
Metabolic and Endocrine 333072 333072 0 0
Normal metabolism and endocrine development and function

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This observational study involves the collection from each time point (below): Blood samples, rectal swabs, frozen stool and bronchoalveolar lavage/ wash samples, processed and stored whole or as derivatives. To help us define the interaction between the microbiome and the outcomes of participants' transplant or cellular therapy.

Clinical information and samples will be collected prospectively at the following timepoints for participants receiving Hematopoietic Stem Cell Transplantation (HSCT):
- The day of patients transplant (Day 0);
- Day 14 post-transplant;
- Day of hospital discharge; and
- Day 100
Participants who receive HSCT, are also invited to undergo the optional PET-scan at Day 14-18 post-transplant, and may be invited for a repeat scan if they are readmitted with GVHD.

Patients who receive Chimeric Antigen Receptor (CAR) T/Natural Killer (NK) cellular therapy will have samples collected:
- Day of infusion;
- Day 14;
- Day 30 and;
- Day 100 post-infusion

For patients that receive Solid Organ Transplantation, will have samples collected:
- Prior to their scheduled transplant (Day of Listing on this study)
- Day of transplant;
- Day of hospital discharge post-transplant;
- Day 21 post-transplant procedure;
- Day 90 post-transplant;
- 6 months post-transplant; and
- 12 months post-transplant

Participants may also be invited to donate samples if they are readmitted to hospital with an infection, or GVHD.

Participants enrolled in this study will also have clinical information collected (if consented) during their collection timepoints and at Month 6 and 12 post-transplant/infusion check-ups. This may include disease indication, characteristics of Transplant and Cellular Therapy (TCT), incidence of acute toxicities and disease response, and incidence of longer-term complications, survival and episodes of Infection, GVHD and organ rejection. As well as the collection of information regarding other indirect complications of TCT, including but not limited to GVHD, infectious complications, immunological complications, duration of hospitalization and use of concurrent medications
Intervention code [1] 330487 0
Early Detection / Screening
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 340801 0
To characterise the Intestinal microbial composition outcomes following transplantation and cellular therapies.
Assessment method [1] 340801 0
Rectal swabs will be ran in batched shotgun metagenomic sequencing and MetaPanel analysis. Stool samples from Cohort 1, will undergo bacterial sequencing using a novel technique, i.e., IgA-LongReadSeq. Coupled with long-read sequencing to output quality genomic analysis. Metabolite and metabolomic analysis of stool and blood samples will be performed using high accuracy orbitrap mass spectrometry and a highly curated subset of relevant metabolites
Timepoint [1] 340801 0
Participants who receive CAR T/NK cellular therapy or Hematopoietic Stem Cell Transplantation (HSCT) will have their faecal (rectal swab and solid stool) samples analysed from the timepoints: Day 0 (day of infusion/transplantation), Day 14, Day 30 or day of hospital discharge, and Day 100. Participants may also be invited to have additional samples collected if readmitted with Infection and/or Graft-versus-Host-Disease (GVHD) while enrolled in the study. Participants who receive Solid Organ Transplantation (SOT) will have faecal samples collected at differing timepoints: Day of listing, Day of transplant, Day of discharge from the hospital, Day 21, and 90 post-transplant, and Month 6 and 12 post-transplant. Participants who receive SOT will also be invited to donate samples if they are readmitted while enrolled in the study.
Primary outcome [2] 341045 0
To characterise the composition and diversity of the Gastrointestinal (GI) Microbiome in Transplant and Cellular Therapy (TCT) patients.
Assessment method [2] 341045 0
Faecal bacterial sequencing, faecal microbial metabolite and metabolomic measurement, and Metabolite analysis.
Timepoint [2] 341045 0
Participants who receive CAR T/NK therapy or HSCT will have a rectal swab, and solid stool sample analysed from the timepoints: Day 0 (day of infusion/transplantation), Day 14, Day 30 or day of hospital discharge, and Day 100. Participants who receive Solid Organ Transplantation (SOT) will have faecal samples collected at differing timepoints: Day of listing, Day of transplant, Day of discharge from the hospital, Day 21, and 90 post-transplant, and Month 6 and 12 post-transplants. Participants may also be invited to have additional samples collected if readmitted while enrolled in the study.
Primary outcome [3] 341047 0
Measurement and characterisation of Short Chain Fatty Acid (SCFA) levels in participant's biological samples
Assessment method [3] 341047 0
SCFA will be obtained via collected biological samples (e.g., stool, blood plasma/serum); Faecal bacterial sequencing, faecal microbial metabolite and metabolomic measurement, Bronchiolar lavage bacterial sequencing, blood SCFA and Metabolite analysis
Timepoint [3] 341047 0
Participants who receive CAR T/NK therapy or HSCT will have their blood and stool samples analysed from the timepoint: Day 0 (day of infusion/transplantation), Day 14, Day 30 or day of hospital discharge, and Day 100. Participants may also be invited to have additional samples collected if readmitted with Infection and/or GVHD while enrolled in the study. Participants who receive Solid Organ Transplantation (SOT) will have blood, faecal, and Bronchial Wash samples collected at differing timepoints: Day of listing, Day of transplant, Day of discharge from the hospital, Day 21, and 90 post-transplant, and Month 6 and 12 post-transplants. Participants who receive SOT will also be invited to donate samples if they are readmitted while enrolled in the study.
Secondary outcome [1] 445230 0
To evaluate the accuracy of integrated, comprehensive multiomics analyses in predicting GI-GVHD, compared to clinical information and patient outcomes obtained throughout their enrolment.
Assessment method [1] 445230 0
Metagenomic microbial sequencing, measurement of microbe-derived metabolites, immune cell enumeration and phenotyping and FDG-PET analyses.
Timepoint [1] 445230 0
Participants who receive CAR T/NK cellular therapy or HSCT will have their blood and stool samples analysed from the timepoints: Day 0 (day of infusion/transplantation), Day 14, Day 30 or day of hospital discharge, and Day 100. Participants may also be invited to have additional samples collected if readmitted with Infection and/or GVHD while enrolled in the study.
Secondary outcome [2] 445231 0
To detect and monitor the carriage of AMR genes and pathogens over time in the intestinal microbiota of transplant and cellular therapy patients
Assessment method [2] 445231 0
Clinical data obtained from your medical records which include transplant type, antibiotic use and infections experienced will be collected and analysed. Where AMR genes are detected by faecal sequencing, additional samples may be collected at the next available sample timepoint for culture.
Timepoint [2] 445231 0
If participants are found to have AMR genes/pathogens while enrolled in the study, samples will be collected at their next scheduled timepoint of specimen collection. If participants are readmitted to hospital, while enrolled, they may be asked by the investigator to donate blood and stool samples when convenient.
Secondary outcome [3] 445232 0
To characterise lung microbiome outcomes in solid organ transplant patients.
Assessment method [3] 445232 0
Clinicopathological correlation, Bronchiolar Lavage bacterial sequencing, Immune and Cellular Analysis, Faecal metagenomic sequencing and MetaPanel analysis, and Faecal Microbial Metabolite and Metabolomic Measurement.
Timepoint [3] 445232 0
Participants who receive Solid Organ Transplantation (SOT) will have blood, faecal, and/or Bronchial Wash samples collected at the following timepoints: - Day of listing, - Day of transplant, - Day of discharge from the hospital, - Day 21, and 90 post-transplant, and - Month 6 and 12 post-transplant. Participants who receive SOT will also be invited to have samples collected if they are readmitted to hospital while enrolled in the study.
Secondary outcome [4] 445949 0
Primary Outcome: Characterising the interaction of immune function in TCT patients
Assessment method [4] 445949 0
Assessment may include but not be limited to immune markers and immune cell populations, such as cytokine profiles from blood samples.
Timepoint [4] 445949 0
Participants who receive CAR T/NK therapy or HSCT will have their blood and stool samples analysed from the timepoint: Day 0 (day of infusion/transplantation), Day 14, Day 30 or day of hospital discharge, and Day 100. Participants may also be invited to have additional samples collected if readmitted with Infection and/or GVHD while enrolled in the study. Participants who receive Solid Organ Transplantation (SOT) will have blood, faecal, and Bronchial Wash samples collected at differing timepoints: Day of listing, Day of transplant, Day of discharge from the hospital, Day 21, and 90 post-transplant, and Month 6 and 12 post-transplants. Participants who receive SOT will also be invited to donate samples if they are readmitted while enrolled in the study.
Secondary outcome [5] 445950 0
Clinical information/outcomes will be collected to categorize and correlate TCT patient responses to their transplant or cellular therapy.
Assessment method [5] 445950 0
Clinical information/outcome of participants will involve composite correlation of their Disease indication, characteristics of HSCT/CAR-T/SOT, incidence of acute toxicities and disease response, and incidence of longer-term complications, survival and episodes of Infection, GVHD and organ rejection. This will include collection of information regarding other indirect complications of TCT including but not limited to GVHD, infectious complications, immunological complications, duration of hospitalization and use of concurrent medications. This clinical annotation of samples will provide insight into patient groups with the highest rates of complications, and identification of factors linked to clinical outcome
Timepoint [5] 445950 0
A baseline dataset plus specified clinical information will be collected at each time point, as well as 6 and 12 months post-procedure. If novel scientific findings prompt requirement for additional clinicopathological correlation, clinical data may be obtained from the participant’s medical record.

Eligibility
Key inclusion criteria
- Age 18 years or older;
- Able to provide voluntary informed consent;
- Planned administration of allogeneic HSCT, CAR T/NK or SOT.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Unwilling or unable to undertake specific components of the study, such as:
- Venepuncture;
- Provision of faecal specimens;
- Rectal swab
2. Allergy/intolerance to FDG; these subjects may still be enrolled for specimen provision but abstain from the FDG-PET component.

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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
5/05/2025
Actual
Date of last participant enrolment
Anticipated
29/12/2028
Actual
Date of last data collection
Anticipated
30/03/2029
Actual
Sample size
Target
250
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 27658 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [2] 27659 0
The Prince Charles Hospital - Chermside
Recruitment postcode(s) [1] 43832 0
4029 - Herston
Recruitment postcode(s) [2] 43833 0
4032 - Chermside

Funding & Sponsors
Funding source category [1] 318355 0
Government body
Name [1] 318355 0
Department of Health and Aged Care: Medical Research Future Fund (MRFF)
Country [1] 318355 0
Australia
Funding source category [2] 318370 0
Government body
Name [2] 318370 0
NHMRC Ideas Grant
Country [2] 318370 0
Australia
Primary sponsor type
Government body
Name
Metro North Hospital and Health Service (MNHHS)
Country
Australia
Secondary sponsor category [1] 320769 0
None
Name [1] 320769 0
Country [1] 320769 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316986 0
Metro North Health Human Research Ethics Committee
Ethics committee address [1] 316986 0
Ethics committee country [1] 316986 0
Australia
Date submitted for ethics approval [1] 316986 0
Approval date [1] 316986 0
08/01/2025
Ethics approval number [1] 316986 0

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 139662 0
A/Prof Andrea Henden
Address 139662 0
Royal Brisbane and Women's Hospital. Butterfield St, Herston 4006 QLD.
Country 139662 0
Australia
Phone 139662 0
+61736461340
Email 139662 0
Andrea.Henden@health.qld.gov.au
Contact person for public queries
Name 139663 0
Andrea Henden
Address 139663 0
Royal Brisbane and Women's Hospital. Butterfield St, Herston 4006 QLD.
Country 139663 0
Australia
Phone 139663 0
+61736461340
Email 139663 0
Andrea.Henden@health.qld.gov.au
Contact person for scientific queries
Name 139664 0
Andrea Henden
Address 139664 0
Royal Brisbane and Women's Hospital. Butterfield St, Herston 4006 QLD.
Country 139664 0
Australia
Phone 139664 0
+61736461340
Email 139664 0
Andrea.Henden@health.qld.gov.au

Data sharing statement
Will the study consider sharing individual participant data?
No


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.