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Trial registered on ANZCTR


Registration number
ACTRN12621001146886
Ethics application status
Approved
Date submitted
17/04/2021
Date registered
25/08/2021
Date last updated
25/08/2021
Date data sharing statement initially provided
25/08/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Predictors of Immune Related Adverse Events from the use of the Immunotherapy in Patients with Cancer
Scientific title
A comprehensive ImmuNe-related adVerse Event (irAE) database associated with immune checkpoint use in SouTh WEst SyDney to investigate mechanisms and impact of adverse effects in patients with cancer.
Secondary ID [1] 303982 0
Nil known
Universal Trial Number (UTN)
Nil known
Trial acronym
INVESTED
Linked study record
Nil

Health condition
Health condition(s) or problem(s) studied:
Solid Malignancies where patients are receiving immune checkpoint inhibitors - either alone or in combination with other anti-cancer agents 321596 0
Condition category
Condition code
Cancer 319337 319337 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
- Collection of demographic, treatment and disease based factors from review of the patients' medical records. This includes age, sex, co-morbidities, list of medications, date of diagnosis, type of cancer, histopathology, type of treatment, intent of treatment, date treatment was commenced and outcome (disease response, progression or stabilisation). Participants will provide consent for this information to be collected from their medical files.
- Collection of blood samples (3x tubes for, 2x EDTA, 1 x serum) for storage and testing at the following time points (baseline i.e. before starting treatment, before the second cycle of treatment with immune checkpoint inhibitors, before the third cycle of treatment with checkpoint inhibitors, at 12 months following commencement of immune checkpoint inhibitor therapy (if still on this) and on development of a grade 2 or greater immune related adverse event at any point from commencement of an immune checkpoint inhibitor
- Collection of stool sample at baseline and before second cycle of treatment with immunotherapy
- Access to tissue collected at biopsy or cytology before commencement of treatment, where accessible. No additional biopsy will be required.
- The overall duration of observation will be 12 months from recruitment.
Intervention code [1] 320290 0
Early Detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 327204 0
T-cell repertoire using T cell receptor sequencing
Timepoint [1] 327204 0
T cell repertoire at baseline, on bloods conducted before commencement of cycle 2, on bloods before commencement of cycle 3 and at the onset of a grade 2 or greater immune related adverse event
Primary outcome [2] 328644 0
Auto-antibodies using line blots
Timepoint [2] 328644 0
Auto-antibodies at baseline, on bloods conducted before commencement of cycle 2 and on bloods before commencement of cycle 3 and at the onset of a grade 2 or greater immune related adverse event
Secondary outcome [1] 394200 0
Changes in peripheral blood cells - specifically, development of eosinophilia
Timepoint [1] 394200 0
Peripheral blood cell levels at baseline, on bloods conducted before commencement of cycle 2 and on bloods before commencement of cycle 3 and at the onset of a grade 2 or greater immune related adverse event
Secondary outcome [2] 394201 0
Markers of body composition index measured through analysis of whole body fat and fat free mass using routine CT scans
Timepoint [2] 394201 0
At baseline, before commencement of treatment with immune checkpoint inhibitors and upon first and second re-staging scans which will be performed at the oncologists discretion whilst the patient is on treatment with immune checkpoint inhibitors
Secondary outcome [3] 400097 0
Changes in peripheral blood cells - specifically, high neutrophil to lymphocyte ratio
Timepoint [3] 400097 0
Peripheral blood cell levels at baseline, on bloods conducted before commencement of cycle 2 and on bloods before commencement of cycle 3 and at the onset of a grade 2 or greater immune related adverse event
Secondary outcome [4] 400098 0
Changes in peripheral blood cells - specifically, development of thrombocytopenia
Timepoint [4] 400098 0
Peripheral blood cell levels at baseline, on bloods conducted before commencement of cycle 2 and on bloods before commencement of cycle 3 and at the onset of a grade 2 or greater immune related adverse event

Eligibility
Key inclusion criteria
All patients with histologically or cytologically confirmed solid organ malignancies starting immune checkpoint inhibitors alone or in combination with chemotherapy

Patients receiving treatment in either the adjuvant or metastatic settings

Age >= 18 years

Ability to provide informed consent for the study procedures and data collection

Willingness and ability to comply with the study requirements

Signed, written informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with prior exposure to immune checkpoint inhibitors

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
This is an exploratory prospective single arm cohort study.

A biostatistician has been consulted for input into the statistical analysis plan of this study.

For the primary objective, a cox-based regression model with time varying covariates will be used to analyse the primary outcome. Multiple event analyses will be considered.

For the secondary objectives:
• Multilevel models will be utilised assessing clinical, laboratory and blood based variables with treatment response
• A cox-regression model with time varying co-variates will be used to assess clinical, laboratory and blood based variables with survival

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
28/04/2021
Date of last participant enrolment
Anticipated
1/02/2022
Actual
Date of last data collection
Anticipated
30/06/2022
Actual
Sample size
Target
120
Accrual to date
12
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 19134 0
Liverpool Hospital - Liverpool
Recruitment hospital [2] 19135 0
Campbelltown Hospital - Campbelltown
Recruitment postcode(s) [1] 33693 0
2170 - Liverpool
Recruitment postcode(s) [2] 33694 0
2560 - Campbelltown

Funding & Sponsors
Funding source category [1] 308361 0
University
Name [1] 308361 0
Western Sydney University
Country [1] 308361 0
Australia
Funding source category [2] 308363 0
Other Collaborative groups
Name [2] 308363 0
Ingham Institute
Country [2] 308363 0
Australia
Funding source category [3] 308364 0
Hospital
Name [3] 308364 0
Department of Medical Oncology, Clinical Trial Funds, Liverpool Hospital
Country [3] 308364 0
Australia
Funding source category [4] 308365 0
Hospital
Name [4] 308365 0
Department of Immunology, Campbelltown Hospital
Country [4] 308365 0
Australia
Primary sponsor type
University
Name
Western Sydney University
Address
Western Sydney University, Narellan Road & Gilchrist Drive, Campbelltown NSW 2560
Country
Australia
Secondary sponsor category [1] 309182 0
None
Name [1] 309182 0
Address [1] 309182 0
Country [1] 309182 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308333 0
South Western Sydney Local Health DistrictHuman Research Ethics Committee
Ethics committee address [1] 308333 0
Research Directorate
Locked Bag 7279
Eastern Campus
Liverpool BC NSW 1871
Ethics committee country [1] 308333 0
Australia
Date submitted for ethics approval [1] 308333 0
Approval date [1] 308333 0
11/03/2021
Ethics approval number [1] 308333 0
2020/ETH03197:

Summary
Brief summary
This study is aiming to create an adverse event database to document any negative side effects that people with cancer who are taking specific immunotherapy drugs (immune checkpoint inhibitors) may experience.

Who is it for?
You may be eligible for this study if you are aged 18 or older, you have been diagnosed with any type of cancer that features solid tumours and you are about to start an immune checkpoint inhibitor therapy alone or in combination with chemotherapy.

Study details
All participants who choose to enrol in this study will be asked to provide a blood sample once before they start the immunotherapy and then before the second and third cycle of treatment. Participants will also be asked to provide stool and tissue samples before starting treatment and before the second cycle, for biomarker analysis. All participants will be asked to list any side effects/adverse events that they experience while taking the immunotherapy drugs to their usual treating oncologist.

It is hoped this research will identify potential biomarkers and clinical features that may predict adverse events related to treatment with immune checkpoint inhibiting drugs that are increasingly being used to treat cancer patients. This information may then be used to improve health outcomes for future cancer patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 110338 0
Dr Sana Haider
Address 110338 0
Liverpool Cancer Therapy Centre
1 Campbell Street
Liverpool
NSW 2170
Country 110338 0
Australia
Phone 110338 0
+61406652148
Fax 110338 0
Email 110338 0
[email protected]
Contact person for public queries
Name 110339 0
Sana Haider
Address 110339 0
Liverpool Cancer Therapy Centre
1 Campbell Street
Liverpool
NSW 2170
Country 110339 0
Australia
Phone 110339 0
+61406652148
Fax 110339 0
Email 110339 0
[email protected]
Contact person for scientific queries
Name 110340 0
Sana Haider
Address 110340 0
Liverpool Cancer Therapy Centre
1 Campbell Street
Liverpool
NSW 2170
Country 110340 0
Australia
Phone 110340 0
+61406652148
Fax 110340 0
Email 110340 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.