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Trial registered on ANZCTR


Registration number
ACTRN12620001287921
Ethics application status
Approved
Date submitted
17/09/2020
Date registered
27/11/2020
Date last updated
27/11/2020
Date data sharing statement initially provided
27/11/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Assessment of DNA damage-repair capacity in systemic lupus erythematosus patients as a potential biomarker of response to cyclophosphamide.
Scientific title
Assessment of DNA damage-repair capacity in systemic lupus erythematosus patients as a potential biomarker of response to cyclophosphamide.
Secondary ID [1] 302335 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lupus nephritis 319105 0
Condition category
Condition code
Inflammatory and Immune System 317063 317063 0 0
Autoimmune diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The study involves collection of a single blood sample from patients diagnosed with systemic lupus erythematosus. Information on age, gender, self-identified ethnicity will be collected as well as data from the medical notes about recent lab-test results on lupus, kidney function and medications received as part of routine care.
This is a single observation at this one timepoint.
Intervention code [1] 318627 0
Early Detection / Screening
Comparator / control treatment
Healthy volunteers donating blood from 2018- to current date. These are volunteers recruited at the University of Auckland under a separate ethics approval for collection of blood sample for use in this assay
Control group
Historical

Outcomes
Primary outcome [1] 325157 0
To assess the range of IC50 values of phosphoramide-induced QPCR-block in ex vivo treated peripheral blood mononuclear cells (PBMC) from lupus nephritis patients.
Timepoint [1] 325157 0
Following sample collection for each participant
Secondary outcome [1] 387029 0
none
Timepoint [1] 387029 0
not applicable

Eligibility
Key inclusion criteria
>18 years of age
Diagnosed with lupus nephritis
Able to give informed consent
Not currently receiving cyclophosphamide or other alkylating agent
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Not able to provide a blood sample
Currently taking cyclophosphamide or other alkylating agent

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Convenience sample
Timing
Both
Statistical methods / analysis
The range of IC50 values (in ex vivo treated blood cells) from up to n=17 donors will be reported. The mean and SD (or median, IQR) will be reported. The data will be compared to data collected from a historical group of healthy volunteer donors. Comparison of the means of the continuous variable ( IC50 values) between the groups (patient vs heathy controls) will be assessed using T-test and a P value <0.05 will be considered significant.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 22993 0
New Zealand
State/province [1] 22993 0
Auckland

Funding & Sponsors
Funding source category [1] 306764 0
University
Name [1] 306764 0
University of Auckland
Address [1] 306764 0
Private Bag 92019. Victoria Street West Auckland 1142. New Zealand
Country [1] 306764 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
Private Bag 92019. Victoria Street West Auckland 1142. New Zealand
Country
New Zealand
Secondary sponsor category [1] 307318 0
None
Name [1] 307318 0
Address [1] 307318 0
Country [1] 307318 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306929 0
Northern B Health and Disability Ethics Committee
Ethics committee address [1] 306929 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 306929 0
New Zealand
Date submitted for ethics approval [1] 306929 0
23/07/2020
Approval date [1] 306929 0
17/08/2020
Ethics approval number [1] 306929 0
20/NTB/182

Summary
Brief summary
Cyclophosphamide is one of several medications that may be used to help to treat damage to the kidney that can occur in some patients with systemic lupus erythematosus (lupus nephritis). Unfortunately treatment with cyclophosphamide is not always successful in every patient. Cyclophosphamide works by killing the over-active immune cells which are causing inflammation in the kidney. Recent international research suggests that, compared with healthy volunteers, immune cells from patients with lupus have a decreased ability to repair the type of damage caused by drugs like cyclophosphamide. We want to investigate whether a test using cells collected from a blood sample can detect this type of decreased repair activity.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 105482 0
A/Prof Nuala Helsby
Address 105482 0
Molecular Medicine and Pathology, Faculty of Medical and Health Sciences, University of Auckland, Private Bag 92019, Auckland 1145, New Zealand.
Country 105482 0
New Zealand
Phone 105482 0
+6499239831
Fax 105482 0
Email 105482 0
n.helsby@auckland.ac.nz
Contact person for public queries
Name 105483 0
A/Prof Nuala Helsby
Address 105483 0
Molecular Medicine and Pathology, Faculty of Medical and Health Sciences, University of Auckland, Private Bag 92019, Auckland 1142, New Zealand.
Country 105483 0
New Zealand
Phone 105483 0
+6499239831
Fax 105483 0
Email 105483 0
n.helsby@auckland.ac.nz
Contact person for scientific queries
Name 105484 0
A/Prof Nuala Helsby
Address 105484 0
Molecular Medicine and Pathology, Faculty of Medical and Health Sciences, University of Auckland, Private Bag 92019, Auckland 1142, New Zealand.
Country 105484 0
New Zealand
Phone 105484 0
+6499239831
Fax 105484 0
Email 105484 0
n.helsby@auckland.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This is an ex vivo study of activity in blood cells and only the range of data will be reported.
What supporting documents are/will be available?
No other documents available
Summary results
No Results