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Trial registered on ANZCTR


Registration number
ACTRN12621000176864
Ethics application status
Approved
Date submitted
2/11/2020
Date registered
18/02/2021
Date last updated
18/02/2021
Date data sharing statement initially provided
18/02/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
MEL-SELF: a randomised controlled trial of patient-led surveillance compared to clinician-led surveillance in people treated for localised melanoma.
Scientific title
MEL-SELF: a randomised controlled trial of patient-led surveillance compared to clinician-led surveillance for the detection of new primary or recurrent melanoma.
Secondary ID [1] 300884 0
Nil known
Universal Trial Number (UTN)
U1111-1250-3619
Trial acronym
MEL-SELF
Linked study record
This randomised controlled trial is linked to a pilot project ACTRN12616001716459. NCT03581188 is also a pilot of this study.

Health condition
Health condition(s) or problem(s) studied:
Melanoma 316817 0
Keratinocyte skin cancer 316818 0
Condition category
Condition code
Cancer 315025 315025 0 0
Malignant melanoma
Cancer 315026 315026 0 0
Non melanoma skin cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Before randomisation, all potential participants undergo an active run-in phase.
In the active run-in phase participants will be asked to:
• complete an online Baseline Questionnaire measuring demographics, knowledge, attitudes and confidence on self-examination and smartphone applications, and their baseline level of fear of new or recurrent melanoma (using a melanoma specific version of the Fear of Cancer Recurrence Index)
• log-in to the web-based ASICA skin checker platform, view instructional videos, and undertake guided total skin self-examination and electronic reporting of their findings
• upload a macroscopic digital photo, using their smartphone, of a predetermined target lesion and a photo of their back (to document sun damage) to the study’s web-based platform (in REDCap).
The active run-in phase will occur approximately one week prior to randomisation and participants who successfully complete all activities will continue in the trial.

Intervention details
The intervention arm will receive the intervention (patient-led surveillance) as an adjunct to usual care (clinician-led surveillance) for 12 months from the date of randomisation.
They receive clinician-led surveillance:
• An educational booklet ‘Your guide to early melanoma’ (freely available at https://www.melanoma.org.au/melanoma/assets/File/Stage%20I%20and%20II%20(Early%20Stage)%20Melanoma%20Information%20Packs_FINAL.pdf)
• Routinely scheduled visits as per treating clinician.
• Unscheduled (short notice) visits as needed through usual referral pathways (e.g. local general practitioner).
In addition, they receive patient-led surveillance:
• Continued access to web-based ASICA skin checker instructional videos as described in Murchie P, Allan JL, Brant W, et al: Total skin self-examination at home for people treated for cutaneous melanoma: development and pilot of a digital intervention. BMJ Open 5:e007993, 2015.
• A mobile dermatoscope to attach to their phone, with random allocation to either low cost (non-polarised light source) or higher cost device (polarised light source). Detailed written and video instructions on how to use the dermatoscope and accompanying smartphone app (readily available to anyone who purchases the device – i.e. not study specific).
• One-to-one training for the participant and their partner on how to use the dermatoscope and accompanying app, delivered by web conferencing. The frequency and duration of training will be tailored to the participants needs and preferences
• Email or SMS text (dependent on participant preference) reminders every 3 months to perform skin self-examination.
• Teledermatology:
Participants take dermoscopic images of a “target” lesion determined by their treating clinician and up to 8 additional lesions of concern.
These images are submitted through the dermatoscope smartphone app and transmitted to one of the study teledermatologists who will undertake review within 3 working days.
The results are reported to the participant and study personnel.
• A fast-tracked unscheduled clinic visit is facilitated by study staff if recommended by the teledermatologist.

Adherence will be measured through self-report in questionnaires at baseline, 6 and 12 months and through the submission of a minimum of one and a maximum of eight images at the end of each three-month cycle.

In addition, a nested qualitative study will be conducted to understand patients’ and clinicians’ acceptability and satisfaction with the intervention and explore components which may need to be changed for implementation into routine clinical practice. A sub-set of participants from both study arms and all clinicians of intervention arm patients will be approached and invited to take part in semi structured telephone interviews. Up to 45 semi-structured interviews will be held with patients, and up to 10 semi-structured interviews will be held with clinicians. We will invite participants who indicated their interest in taking part in the interviews. We will use purposive sampling of participants who opt-in to this additional interview component to maximise diversity of experience. We anticipate recruiting 30-45 participants for the nested qualitative study, a sample size commonly sufficient to reach saturation in themes and topics.
Intervention code [1] 317210 0
Early detection / Screening
Comparator / control treatment
The control arm will receive clinician-led surveillance (usual care) which involves:
• An educational booklet ‘Your guide to early melanoma’ (freely available at https://www.melanoma.org.au/melanoma/assets/File/Stage%20I%20and%20II%20(Early%20Stage)%20Melanoma%20Information%20Packs_FINAL.pdf)
• Routinely scheduled visits as per treating clinician.
• Unscheduled visits if needed.
Control group
Active

Outcomes
Primary outcome [1] 323326 0
Proportion of participants who are diagnosed with a new primary or recurrent melanoma (any stage) at an unscheduled visit at the treatment centre during the 12 months follow-up of the trial. All new melanoma diagnoses will be identified through patient medical records, and through data linkage to the NSW cancer registry. The slides for all new melanoma diagnoses will be reviewed by the trial dermatopathologist, masked to randomised arm of the participant to confirm or refute the melanoma diagnosis.
Timepoint [1] 323326 0
At 12 months after randomisation.
Secondary outcome [1] 381573 0
Time to diagnosis of any skin cancer: time from randomisation to the diagnosis of a melanoma or non-melanoma skin cancer, identified through patient medical records.
Timepoint [1] 381573 0
At 12 months after randomisation
Secondary outcome [2] 381575 0
Fear of Cancer Recurrence (FCR) will be assessed using a modified (i.e. melanoma-specific) version of the 9-item Fear of Cancer Recurrence Inventory (FCRI) severity subscale, with each item scored on a 5-point Likert scale. The final score is calculated by summing the scores for the relevant items. The total score for each participant ranges from 0 to 36. A higher score is indicative of greater FCR.
Timepoint [2] 381575 0
At Baseline, 6 months and 12 months after randomisation
Secondary outcome [3] 381576 0
Anxiety, stress and depression will be measured using the short version of the Depression Anxiety and Stress Scales (DASS-21). The DASS-21 is a set of three 7-item self-report scales, with each scored on a 4-point Likert scale designed to measure depression, anxiety and stress.
Timepoint [3] 381576 0
At Baseline, 6 months and 12 months after randomisation.
Secondary outcome [4] 381577 0
Acceptability of reduction in scheduled clinic visit frequency will be measured through a 3-item subscale on a 5-point Likert scale designed specifically for this study. For each item, the total score ranges from 0 to 4. A higher score indicates an acceptable reduction in scheduled visits.
Timepoint [4] 381577 0
At Baseline, 6 months and 12 months post randomisation.
Secondary outcome [5] 381578 0
Number of lesions surgically evaluated will be measured through interrogation of clinic data.
Timepoint [5] 381578 0
12 months after randomisation
Secondary outcome [6] 381579 0
Number of clinic visits attended (both scheduled and unscheduled) will be measured through interrogation of clinic data.
Timepoint [6] 381579 0
At 12 months after randomisation
Secondary outcome [7] 387918 0
AJCC substage and pathological characteristics of melanoma including thickness, mitotic rate and other prognostic factors measured through pathology reports, patient medical records, and clinic databases.
Timepoint [7] 387918 0
At 12 months post randomisation
Secondary outcome [8] 387919 0
Resource use: patient out of pocket and health system costs associated with each arm of the trial will be estimated using an online resource use diary. This will be used to document and measure health behaviours and service use - such as hospitalisations, other allied health consultations, use of alternative therapies and self-monitoring behaviours. It will also document days out-of-role (including paid and unpaid work), travel costs and carer costs. The diary will be based on existing resource use questionnaires and the patient diary used in our pilot study.
Timepoint [8] 387919 0
At 12 months post randomisation
Secondary outcome [9] 387920 0
Carbon costs of resources used will be estimated using data from the Australian Industrial Ecology Virtual Laboratory (IELab) and other carbon accounting methods.
Timepoint [9] 387920 0
At 12 months post randomisation
Secondary outcome [10] 387922 0
Adherence with 3 monthly image submission will be measured through interrogation of the study database.
Timepoint [10] 387922 0
At 12 months post randomisation
Secondary outcome [11] 389744 0
Participant satisfaction with low cost and higher cost dermatoscopes will be assessed using a study-specific questionnaire.
Timepoint [11] 389744 0
At 12 months post randomisation
Secondary outcome [12] 389745 0
Performance of dermatoscopes: quality of the images will be measured using a checklist developed and tested in another teledermatology study*),
*Janda M, Horsham C, Vagenas D, et al: Accuracy of mobile digital teledermoscopy for skin self-examinations in adults at high risk of skin cancer: an open-label, randomised controlled trial. The Lancet Digital Health 2:e129-e137, 2020
Timepoint [12] 389745 0
At 12 months post randomisation
Secondary outcome [13] 389746 0
Performance of dermatoscopes: device deficiencies reported by participants to study staff and recorded in study database.
Timepoint [13] 389746 0
At 12 months post randomisation
Secondary outcome [14] 389747 0
Self-reported adherence with recommended SSE practice (total body self-examination conducted three- monthly) will be measured with a study specific questionnaire.
Timepoint [14] 389747 0
At Baseline, 6 months, 12 months after randomisation.
Secondary outcome [15] 389748 0
Thoroughness of SSE will be assessed by items adapted from Janda et al.
(Janda M, Youl P, Neale R, et al: Clinical skin examination outcomes after a video-based behavioral intervention: analysis from a randomized clinical trial. JAMA Dermatol 150:372-9, 2014)
Timepoint [15] 389748 0
At Baseline, 6 months, 12 months after randomisation.
Secondary outcome [16] 389749 0
Confidence in performing SSE will be assessed by items adapted from Janda et al.
(Janda M, Youl P, Neale R, et al: Clinical skin examination outcomes after a video-based behavioral intervention: analysis from a randomized clinical trial. JAMA Dermatol 150:372-9,
Timepoint [16] 389749 0
At Baseline, 6 months, 12 months after randomisation.
Secondary outcome [17] 389750 0
Beliefs regarding SSE will be assessed by items adapted from Janda et al.
(Janda M, Youl P, Neale R, et al: Clinical skin examination outcomes after a video-based behavioral intervention: analysis from a randomized clinical trial. JAMA Dermatol 150:372-9,
Timepoint [17] 389750 0
At Baseline, 6 months, 12 months after randomisation.
Secondary outcome [18] 389751 0
Attitudes towards SSE will be assessed by items adapted from Janda et al.
(Janda M, Youl P, Neale R, et al: Clinical skin examination outcomes after a video-based behavioral intervention: analysis from a randomized clinical trial. JAMA Dermatol 150:372-9,
Timepoint [18] 389751 0
At Baseline, 6 months, 12 months after randomisation.
Secondary outcome [19] 389752 0
Knowledge of SSE will be assessed by items adapted from Janda et al.
(Janda M, Youl P, Neale R, et al: Clinical skin examination outcomes after a video-based behavioral intervention: analysis from a randomized clinical trial. JAMA Dermatol 150:372-9,
Timepoint [19] 389752 0
At Baseline, 6 months, 12 months after randomisation.
Secondary outcome [20] 390851 0
Patients' experiences with digitally supported self-examination will be assessed by qualitative analysis of semi-structured telephone interviews.
Timepoint [20] 390851 0
At baseline, 6 months and 12 months after randomisation.
Secondary outcome [21] 390852 0
Clinicians' experiences of the benefits and limitations of the intervention will be assessed by qualitative analysis of semi-structured telephone interviews.
Timepoint [21] 390852 0
At baseline, 6 months and 12 months after randomisation
Secondary outcome [22] 390853 0
Patients' experiences of clinician-led surveillance (usual care) will be assessed by qualitative analysis of semi structured telephone interviews with control group participants.
Timepoint [22] 390853 0
At 12 months after randomisation.

Eligibility
Key inclusion criteria
Patients who:
• Have been treated for stage 0/I/II melanoma, and are attending regular melanoma follow-up as indicated by at least one scheduled visit within next 12 months at a recruiting clinic
• Are able to self-examine
• Have a suitable study partner (spouse, partner, family member, friend) to help with self-examination
• Own a compatible smartphone (and have access to Internet / email / SMS text messaging)
• Are having no more frequent than 6 monthly scheduled clinics at treatment centres
• Are able to give informed consent
• Have sufficient English language skills to read the materials and complete the questionnaires
• Are 18+ years old.
• Successfully complete the active run in activities
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who:
• Have ever had stage III/IV melanoma
• Have a known past or current diagnosis of cognitive impairment.
• Were participants in the MEL-SELF pilot trial




Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be randomly assigned to either control or intervention arms with a 1:1 allocation using the NHMRC Clinical Trials Centre’s Interactive voice response system (IVRS) ensuring allocation concealment.
Within the intervention arm, participants will be randomised 1:1 into two arms for the two models of mobile dermatoscope (low cost vs higher cost). The ratio will be adapted depending on adherence with submission of images that are of sufficient quality for teledermatology reporting.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Consenting patients who meet all inclusion/exclusion criteria and complete the active run-in phase will be randomised by minimisation to the intervention or control group ensuring balance of prognostic factors. The prognostic factors that will be used for minimisation are:
• Site ID (two sites = (1) Melanoma Institute Australia / Royal Prince Alfred Hospital and (2) Newcastle Skin Check)
• Patient date of birth (age groups = 18–39, 40–70, 71+)
• Gender (Male, female, other)
• Melanoma Stage (Stage 0, IA, IB, IIA, IIB, IIC)
• New primary melanoma risk score (1-year absolute risk score - High, medium, or low risk in line with the Cust MIA tool) as described in Cust AE, Badcock C, Smith J, et al: A risk prediction model for the development of subsequent primary melanoma in a population-based cohort. British Journal of Dermatology 182:1148-1157, 2020
• Dysplastic naevus syndrome (diagnosis or no diagnosis)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features

Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Sample size
Assuming that 1% of patients in the clinician-led surveillance group have a new primary or recurrent melanoma diagnosed through an unscheduled visit at the treatment centre, we will need to recruit at least 452 participants (226 to patient-led surveillance and 226 to clinician-led surveillance) in order to have at least 80% power to detect a 5% increase in the patient-led surveillance group (i.e. 6% have new or recurrent melanoma diagnosed through unscheduled visit at treatment centre). Assuming up to 25% of study participants drop out (withdraw consent or move interstate) we will recruit 600 participants (300 to patient-led surveillance and 300 to clinician-led surveillance). These calculations assume a two-sided 5% significance level and were done using Fishers exact test. This sample size will also ensure at least 80% power to detect a hazard ratio of 1.71 for time from randomisation to diagnosis of any skin cancer for the patient-led vs clinician-led surveillance groups (due to earlier and increased detection in the patient-led group). This calculation assumes a 20% event rate in the clinician-led surveillance group, 60 events among 300 control participants) a 32% event rate in the patient-led surveillance group (96 events among 300 intervention participants), and 26% event rate overall (115 events among 600 trial participants).

Primary outcome
We will use generalised linear models to investigate the difference between patient-led and clinician-led surveillance on the proportion of participants with a new primary or recurrent melanoma diagnosed through an unscheduled visit at the treatment centre. We will present the proportion of participants with the primary outcome in each randomised group, and the between group difference in proportions, along with the p-value and 95% CI. Unadjusted and adjusted analyses will also be presented. For the latter, we will include baseline measurements of important prognostic variables as covariates in the model. These will include: age, sex, site ID, melanoma substage, new primary melanoma risk score and dysplastic nevus syndrome. We will check the appropriate assumptions for of the model and for any covariate modelled as a continuous variable. The adjusted and unadjusted analysis will be presented as an odds ratio along with the 95% confidence interval and p-value.


Secondary outcomes
We will assess the effect of patient-led and clinician-led surveillance on the secondary outcome of time to diagnosis of any skin cancer (melanoma or NMSC), using Cox proportional hazards model. We will present unadjusted and adjusted analyses. For the latter, we will include the same covariates as for the primary outcome (important prognostic variables for event). We will check the proportional hazards assumption using visual inspection of plots (including Schoenfeld residuals) and corresponding test statistics. Other assumptions to be checked include if there is non-informative censoring and a secular trend. Participants who withdrawal will continue to be followed up unless they have withdrawn their consent or moved interstate. In the case that they have withdrawn their consent or moved interstate, the participants will be censored at last available follow-up. The unadjusted and adjusted hazard ratios with 95% confidence interval and p-values will be reported. If the assumptions including the proportional hazards assumptions are violated, these will be addressed as required. The time to diagnosis will also be analysed allowing for competing risk of death.

The appropriate generalised linear model will be used to assess the remaining secondary outcomes. In general, Poisson regression will be used for count variables, logistic regression for any proportions and multiple linear regression for any continuous variable. We will assess effects on continuous outcomes (adherence with SSE; thoroughness, confidence, beliefs, attitude and knowledge of SSE; level of fear of new or recurrent melanoma severity, general anxiety, stress and depression and acceptability of reducing the frequency of scheduled clinic visits) by including baseline measurement of the outcome as well as other relevant prognostic variables as covariates in the multiple linear regression model. For example, for the outcome: level of fear of new or recurrent melanoma severity, we will include baseline measurement of FCRI severity subscale, and personal history of depression or anxiety as covariates. We will estimate the between group difference in change from baseline for each outcome, together with 95% CI and p-values. We will check the appropriate model assumptions and if any are violated, then we will use other generalised linear models.

Recruitment
Recruitment status
Not yet 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 in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 16173 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 16174 0
The Poche Centre, Melanoma Institute Australia - North Sydney
Recruitment postcode(s) [1] 29715 0
2050 - Camperdown
Recruitment postcode(s) [2] 29716 0
2060 - North Sydney
Recruitment postcode(s) [3] 29717 0
2290 - Charlestown

Funding & Sponsors
Funding source category [1] 305335 0
Government body
Name [1] 305335 0
National Health and Medical Research Council (NHMRC)
Address [1] 305335 0
GPO Box 1421
CANBERRA ACT 2601
Country [1] 305335 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
The University of Sydney
NSW 2006
Country
Australia
Secondary sponsor category [1] 306753 0
None
Name [1] 306753 0
Address [1] 306753 0
Country [1] 306753 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305670 0
Sydney Local Health District Ethics Review Committee (RPAH Zone).
Ethics committee address [1] 305670 0
Missenden Road,
CAMPERDOWN, NSW, 2050
Ethics committee country [1] 305670 0
Australia
Date submitted for ethics approval [1] 305670 0
24/03/2020
Approval date [1] 305670 0
24/07/2020
Ethics approval number [1] 305670 0
X20-0106 & 2019/ETH13612

Summary
Brief summary
This study tests patient-led surveillance which is a new way of following up people who have had an early melanoma (in situ melanoma or stage I or II invasive melanoma). Patient-led surveillance combines skin self-examination and teledermatology, which involves taking pictures of skin lesions on your body with a device attached to your smartphone and uploading these images for a dermatologist to review remotely. This study will investigate if this type of follow-up can diagnose new or recurrent melanoma earlier than if regular clinic visits with the patient’s doctor is used alone.

Who is it for?
You may be eligible for this study if you are 18+ years old, have previously had surgery to remove a melanoma in-situ or early invasive melanoma (stage I or II), own a smartphone, are being followed up at a recruiting dermatology clinic, skin cancer specialist clinic or general practice clinic, and have a suitable study partner (spouse, partner, family member, friend) to help with skin self-examination.

Study details
Participants will be screened via questionnaire, asked to view videos on skin self-examination and to upload test photos via the secure web-based platform. On satisfactory completion of these tasks they will be randomly allocated to either a patient-led surveillance or clinician-led surveillance arm.
Clinician-led surveillance: Educational booklet, regular scheduled appointments with treating clinician, access to unscheduled appointments as required.
Patient-led surveillance: All components of clinician-led surveillance as well as a mobile dermatoscope and smartphone app for taking detailed photos of skin lesions, training in skin self-examination and in using the dermatoscope, and access to timely remote dermatology review of any concerning lesions.
Participants will be asked to complete online questionnaires and patient diaries. Their clinical data and any relevant diagnoses will also be collected.

Information from this study will allow investigators to document the efficacy of patient-led surveillance in terms of melanoma diagnoses and resource use.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 101166 0
A/Prof Katy Bell
Address 101166 0
Rm 131 Edward Ford Building A27 | The University of Sydney | NSW 2006
Country 101166 0
Australia
Phone 101166 0
+61 2 9351 4823
Fax 101166 0
Email 101166 0
katy.bell@sydney.edu.au
Contact person for public queries
Name 101167 0
A/Prof Katy Bell
Address 101167 0
Rm 131 Edward Ford Building A27 | The University of Sydney | NSW 2006
Country 101167 0
Australia
Phone 101167 0
+61 2 9351 4823
Fax 101167 0
Email 101167 0
mel-self@sydney.edu.au
Contact person for scientific queries
Name 101168 0
A/Prof Katy Bell
Address 101168 0
Rm 131 Edward Ford Building A27 | The University of Sydney | NSW 2006
Country 101168 0
Australia
Phone 101168 0
+61 2 9351 4823
Fax 101168 0
Email 101168 0
mel-self@sydney.edu.au

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 non-identifiable participant data will be made available to other researchers to maximise the benefits that can be derived from the data. A data dictionary and code book will be available. It will be made available in Excel format either .csv or .xlsx format.
When will data be available (start and end dates)?
Data will be available from within 12 Months of final publication of all study results until 15 years after trial completion.
Available to whom?
Data will be made available on a case by case basis at the discretion of the Coordinating Principal Investigator, Associate Professor Katy Bell.
Available for what types of analyses?
Data will be made available on a case by case basis at the discretion of the Coordinating Principal Investigator, Associate Professor Katy Bell.
How or where can data be obtained?
Access to the data will be arranged by contacting the Coordinating Principal Investigator, Associate Professor Katy Bell by email at mel-self@sydney.edu.au.
What supporting documents are/will be available?
Study protocol
Statistical analysis plan
Informed consent form
Clinical study report
Ethical approval
How or where can supporting documents be obtained?
Type [1] 8658 0
Study protocol
Citation [1] 8658 0
Link [1] 8658 0
Email [1] 8658 0
mel-self@sydney.edu.au
Other [1] 8658 0
Attachment [1] 8658 0
Type [2] 8671 0
Statistical analysis plan
Citation [2] 8671 0
Link [2] 8671 0
Email [2] 8671 0
mel-self@sydney.edu.au
Other [2] 8671 0
Attachment [2] 8671 0
Type [3] 8672 0
Informed consent form
Citation [3] 8672 0
Link [3] 8672 0
Email [3] 8672 0
mel-self@sydney.edu.au
Other [3] 8672 0
Attachment [3] 8672 0
Type [4] 8674 0
Ethical approval
Citation [4] 8674 0
Link [4] 8674 0
Email [4] 8674 0
mel-self@sydney.edu.au
Other [4] 8674 0
Attachment [4] 8674 0
Type [5] 9471 0
Clinical study report
Citation [5] 9471 0
Link [5] 9471 0
Email [5] 9471 0
mel-self@sydney.edu.au
Other [5] 9471 0
Attachment [5] 9471 0
Summary results
No Results