Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000546853
Ethics application status
Approved
Date submitted
18/02/2021
Date registered
11/05/2021
Date last updated
17/11/2021
Date data sharing statement initially provided
11/05/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
SERENITY: a case-controlled study of risk factors for developing breast implant associated lymphoma
Scientific title
SERENITY: a case-controlled study of risk factors for developing breast implant associated lymphoma
Secondary ID [1] 303507 0
Nil known
Universal Trial Number (UTN)
Trial acronym
SERENITY
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Implant Associated Lymphoma 320834 0
Condition category
Condition code
Cancer 318657 318657 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Cancer 318658 318658 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Public Health 318659 318659 0 0
Other public health

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
non-interventional study.

Reviewing the demographics, lifestyle and procedural factors of patients with breast implant, patients with lymphoma, and patients with both

Participants will be able to self nominate to complete the survey after seeing the study advertisement. They will complete eConsent and then complete an online survey. Whole process will take max 30 minutes.

Participants will not be contacted again

Responses are about:
Age
Sex
Gender
Ethnicity
Private health insurance coverage
Breast Implant Surgery
Lymphoma diagnosis
Alcohol use
Diagnosis of high blood pressure
Diagnosis of high cholesterol
Illicit drug use
Diagnosis of iron deficiency
Occupational exposures & hazards – exposure to benzene or formaldehyde
Other diagnosed medical conditions
Overweight & obesity - BMI
Tobacco use and exposure
Type of implant
Age at implant surgery
Date of surgery
Date of diagnosis of lymphoma
Lymphoma subtype
Stage at diagnosis
Treatment received
Lymphoma screening
Advised of BIAL risk
Intervention code [1] 319794 0
Not applicable
Comparator / control treatment
The SERENITY study will be a case-controlled study utilising a once off patient eConsent and electronic survey of identified population who self elect to complete, compared to the general population using an interactive dataset from a publicly available national database - the Australian Institute of Health and Welfare Australian Burden of Disease Study: Impact and causes of illness and death in Australia, 2015 (Australian Institute of Health and Welfare, 2015). Patients identified in the study population will be case matched by age with the controlled data set
Control group
Historical

Outcomes
Primary outcome [1] 326602 0
Primary Outcome: Lymphoma diagnosis assessed using a study-specific survey to assess how many patients with lymphoma and breast implants also have comorbidities; have high cholesterol; have occupational hazard exposures; have used tobacco; and/or are obese.
Timepoint [1] 326602 0
once off when the patient self elects to complete
Secondary outcome [1] 392075 0
n/a
Timepoint [1] 392075 0
n/a

Eligibility
Key inclusion criteria
• 18 or older
• Capable of providing consent to participate
• Have previously: been diagnosed with lymphoma; or have had breast implant surgery; or have been diagnosed with lymphoma and have also had breast implant surgery.
• Live in Australia.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
none

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Case control
Timing
Both
Statistical methods / analysis
The primary measures in this study are proportions and rates. Estimates of these statistics will include margins of error and comparisons made across populations using appropriate inferential methods. Survey response data will be summarised, displayed, and analysed as applicable for the scale of variables involved.

Split populations have been chosen in order to identify the factors seen in each of the groups with one of the variables only (lymphoma only or breast implants only) so that factors identified can be differentiated between the risk of developing lymphoma without implants and with breast implants. By using an Australian data set, the potential variance from using an international dataset with differing environment, social and health services is removed. Case-matching by age will ensure that the increased risk of developing malignancies as a patient ages is removed.

Results will be analysed with intention to make recommendations for pilot screening program.

Aimed for minimum of 10 in each cohort. If recruitment reaches 25 responses in each cohort, the study will close.
While it would be ideal to collect as many responses as possible, due to the time restrictions based on the dissertation submission requirement of the student Investigators Master course, numbers have been limited.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Study closed sooner than expected due to staff leaving organisation
Date of first participant enrolment
Anticipated
Actual
12/03/2021
Date of last participant enrolment
Anticipated
31/05/2021
Actual
31/08/2021
Date of last data collection
Anticipated
31/05/2021
Actual
31/08/2021
Sample size
Target
75
Accrual to date
Final
11
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC
Recruitment hospital [1] 18762 0
Icon Cancer Centre Richmond - Richmond
Recruitment hospital [2] 18763 0
Icon Cancer Care South Brisbane - South Brisbane
Recruitment hospital [3] 18764 0
Icon Cancer Care Wesley - Auchenflower
Recruitment hospital [4] 18765 0
Icon Cancer Care Chermside - Chermside
Recruitment hospital [5] 18766 0
Icon Cancer Care Southport - Southport
Recruitment hospital [6] 18767 0
Icon Cancer Care Adelaide - Kurralta Park
Recruitment hospital [7] 18768 0
Icon Integrated Cancer Centre North Lakes - North Lakes
Recruitment hospital [8] 18769 0
Icon Cancer Centre Epworth Freemasons - East Melbourne
Recruitment postcode(s) [1] 33208 0
3121 - Richmond
Recruitment postcode(s) [2] 33209 0
4101 - South Brisbane
Recruitment postcode(s) [3] 33210 0
4066 - Auchenflower
Recruitment postcode(s) [4] 33211 0
4032 - Chermside
Recruitment postcode(s) [5] 33212 0
4215 - Southport
Recruitment postcode(s) [6] 33213 0
5037 - Kurralta Park
Recruitment postcode(s) [7] 33214 0
4509 - North Lakes
Recruitment postcode(s) [8] 33215 0
3002 - East Melbourne

Funding & Sponsors
Funding source category [1] 307924 0
Commercial sector/Industry
Name [1] 307924 0
Icon Cancer Centre
Country [1] 307924 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Icon Cancer Centre
Address
Level 1/22 Cordelia Street
South Brisbane, QLD 4101
Country
Australia
Secondary sponsor category [1] 308645 0
University
Name [1] 308645 0
Griffith University
Address [1] 308645 0
170 Kessels Road
Nathan Qld 4111
Country [1] 308645 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307923 0
Griffith University HREC
Ethics committee address [1] 307923 0
170 Kessels Road
Nathan Qld 4111
Ethics committee country [1] 307923 0
Australia
Date submitted for ethics approval [1] 307923 0
09/02/2021
Approval date [1] 307923 0
09/03/2021
Ethics approval number [1] 307923 0
GU Ref No: 2021/097

Summary
Brief summary
The SERENITY study will look at demographic and lifestyle factors, and procedural information of patients with breast implants and lymphoma to determine risk factors for breast implant associated lymphoma

Who is it for?
You may be eligible to join this study if you are aged 18 and above, have had breast implant surgery and/or been diagnosed with lymphoma

Study details
All participants in this study will self nominate to participate by responding to the advertisements. Participants will then complete an eConsent and then a once-time electronic survey. The demographic, lifestyle and procedural information provided/gathered will be used to determine risk factors for developing breast implant associated lymphoma.

It is hoped that the information captured by this study will contribute towards planning for a pilot screening program for BIAL in order to support earlier diagnosis and as such better patient outcomes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 108942 0
Dr Ian Irving
Address 108942 0
Icon Cancer Centre
Level 1/22 Cordelia Street
South Brisbane, QLD 4101
Country 108942 0
Australia
Phone 108942 0
+61737374555
Fax 108942 0
Email 108942 0
[email protected]
Contact person for public queries
Name 108943 0
Mel Grand
Address 108943 0
Icon Cancer Centre
Level 1/22 Cordelia Street
South Brisbane, QLD 4101
Country 108943 0
Australia
Phone 108943 0
+61 437067494
Fax 108943 0
Email 108943 0
[email protected]
Contact person for scientific queries
Name 108944 0
Mel Grand
Address 108944 0
Icon Cancer Centre
Level 1/22 Cordelia Street
South Brisbane, QLD 4101
Country 108944 0
Australia
Phone 108944 0
+61 437067494
Fax 108944 0
Email 108944 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All deidentified patient responses from patients who have opted in to allowing their responses to be used
When will data be available (start and end dates)?
Data will be available from 01 Jan 2022 for a minimum period of 5 years
Available to whom?
Data will be available based on participants chosen response to opting in to the option of 'Sharing with other researchers who may be exploring a different topic than this project.'. This will be on a case-by-case basis of researchers contacting the investigators.
Available for what types of analyses?
any research purpose
How or where can data be obtained?
Via contacting Icon Cancer Centre [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
10748Ethical approval  [email protected] Available on request
10749Informed consent form  [email protected] Available on request
11110Study protocol   



Results publications and other study-related documents

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