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Trial registered on ANZCTR
Registration number
ACTRN12624001120561p
Ethics application status
Submitted, not yet approved
Date submitted
20/08/2024
Date registered
17/09/2024
Date last updated
17/09/2024
Date data sharing statement initially provided
17/09/2024
Type of registration
Prospectively registered
Titles & IDs
Public title
Patient Initiated Follow Up (PIFU) in Endometrial Cancer (PECAN) – a Randomised Pilot Feasibility Study
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Scientific title
Patient Initiated Follow Up (PIFU) in Endometrial Cancer (PECAN) – a Randomised Pilot Feasibility Study
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Secondary ID [1]
312796
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None
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Universal Trial Number (UTN)
None
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Trial acronym
PECAN
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Linked study record
None
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Health condition
Health condition(s) or problem(s) studied:
Endometrial cancer
334859
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Condition category
Condition code
Cancer
331412
331412
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0
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Womb (Uterine or endometrial cancer)
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Public Health
331542
331542
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0
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Health service research
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The experimental intervention is patient initiated follow-up (PIFU).
Participants will be randomised and allocated to either patient initiated follow-up (PIFU) or to standard general practitioner (GP) follow-up (regular 6-monthly visits with their GP).
Participants allocated to the PIFU arm will not have to attend follow-up appointments or their general practitioner for an examination every few months. Instead, they will receive education about symptoms to look out for, which may suggest that their endometrial cancer could have returned (for example, vaginal bleeding).
The Education will be provided by a Research Nurse during one 30 minutes session provided either face-to-face or by telephone one-on-one. Written information about symptoms of endometrial cancer recurrence developed specifically for this study will be provided to participants at this education session by a Research Nurse. Attendance at this education session will be mandatory for study enrolment. The 'teach back' technique will be used to ensure that participants have understood the information. Participants will be asked by the Research Nurse to repeat back the information they have received in their own words.
If participants allocated to the PIFU arm do have any symptoms or are concerned they will be asked to contact the gynaecological cancer clinic and will be offered an urgent clinic appointment.
Participants will be asked to complete three questionnaires about your health and quality of life on two separate occasions.
1. At the beginning of the study, after they have been allocated to either the PIFU group or to the standard GP follow-up group.
2. After 12 months, at the end of the study.
The qualitative sub-study will be 'opt-in' and involve interviews exploring participant experiences of participating in PIFU to explore their views on the acceptability of the intervention. The interviews will be semi-structured and conducted by a psychology researcher at the Psycho-oncology Co-operative Research Group (PoCoG) based at the University of Sydney. The approximate duration of interviews will be 45 minutes. Approximately 20 participants in the PFU arm will be asked to participate. Interviews will be audio-recorded and transcribed. The coding of the interviews will be conducted by a single researcher; a second researcher will conduct an independent audit to confirm that the analysis was systematic and transparent and that the resulting themes are credible. NVivo qualitative data management software will facilitate the organisation and thematic analysis.
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Intervention code [1]
329321
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Treatment: Other
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Comparator / control treatment
Participants allocated to the control arm will receive standard of care follow up that involved 6-monthly follow-up visits with their GP. These visits involve review of symptoms and physical examination. Patients will also receive education to seek review outside of planned follow up schedule if any new symptoms or concerns,
Participants allocated to the PIFU arm will not receive follow-up as this is the intervention.
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Control group
Active
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Outcomes
Primary outcome [1]
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The proportion of eligible patients who enrol in the PECAN pilot study
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Assessment method [1]
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The intervention (PIFU) will be deemed feasible if the recruitment rate is >50%.
The recruitment rate will be determined by an audit of study recruitment records.
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Timepoint [1]
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At completion of the recruitment period
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Primary outcome [2]
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Acceptability
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Assessment method [2]
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Qualitative sub-study.
One 45 minute semi-structured interview will be conducted.
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Timepoint [2]
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12 months
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Secondary outcome [1]
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The proportion of patients randomised to PIFU who self-refer back to the gynaecologic oncology clinic.
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Assessment method [1]
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Number of participants allocated to the PIFU arm who self-refer back to the gynaecological oncology clinic divided by the total number of participants allocated to the PIFU arm.
This will be determined by linking participant data to clinic records
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Timepoint [1]
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Participants will be followed until 12 months post-baseline. The proportion of patients who self-refer back to the gynaecologic oncology clinic will be assessed at the end of the study.
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Secondary outcome [2]
438824
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Fear of Cancer Recurrence
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Assessment method [2]
438824
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Fear of Cancer Recurrence Inventory- Short Form (FCRI-SF)
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Timepoint [2]
438824
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Baseline and 12 months post-baseline
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Secondary outcome [3]
438825
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Cancer recurrence
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Assessment method [3]
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Clinical examination, imaging (CT and PET-CT) and histopathology of biopsy
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Timepoint [3]
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12 months post-baseline
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Secondary outcome [4]
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Quality of life
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Assessment method [4]
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The EORTC Core Quality of Life questionnaire (EORTC QLQ-C30)
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Timepoint [4]
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Baseline and 12 months post-baseline
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Secondary outcome [5]
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Endometrial Cancer Specific Quality of Life
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Assessment method [5]
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Endometrial Cancer Module (EORTC QLQ-EN24)
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Timepoint [5]
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Baseline and 12 months post-baseline
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Eligibility
Key inclusion criteria
1. Women who have completed definitive primary surgical treatment for endometrial endometrioid adenocarcinoma
2. Women who are assessed by a gynaecological oncology multidisciplinary team as having low risk disease in whom adjuvant therapy is not indicated
3. Patients who are clinically well, have no side effects needing ongoing intervention or management, and are not on any active treatment or enrolled in any clinical trials
4. Patients who can access the gynaecological oncology team while undergoing PIFU (access to phone / internet / transport if needed)
5. Non-English-speaking patients with access to interpreter services, and where PROMS are available in the appropriate language, and with capacity to consent to enrol in the trial
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Non-endometrioid histology
2. Not able to engage with PIFU
3. Stage 1B
4. Grade 3
5. p53 abnormal tumours
6. Extensive LVSI
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Centralised randomisation by computer
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
This is a pilot study. Analyses will be descriptive.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
3/02/2025
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Actual
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Date of last participant enrolment
Anticipated
30/01/2026
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Actual
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Date of last data collection
Anticipated
26/02/2027
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Actual
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Sample size
Target
100
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
WA
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Recruitment hospital [1]
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King Edward Memorial Hospital - Subiaco
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Recruitment postcode(s) [1]
43043
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6008 - Subiaco
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Funding & Sponsors
Funding source category [1]
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Charities/Societies/Foundations
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Name [1]
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Australia and New Zealand Gynaecological Oncology Group (ANZGOG)
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Address [1]
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Country [1]
317227
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Australia
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Funding source category [2]
317228
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Charities/Societies/Foundations
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Name [2]
317228
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Australasian Society of Gynaecological Oncologists
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Address [2]
317228
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Country [2]
317228
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Australia
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Primary sponsor type
Hospital
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Name
King Edward Memorial Hospital
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Address
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Country
Australia
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Secondary sponsor category [1]
319506
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None
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Name [1]
319506
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None
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Address [1]
319506
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Country [1]
319506
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Ethics approval
Ethics application status
Submitted, not yet approved
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Ethics committee name [1]
315964
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Child and Adolescent Health Service Human Research Ethics Committee
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Ethics committee address [1]
315964
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https://cahs.health.wa.gov.au/Research/For-researchers/Ethics-and-governance-approval
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Ethics committee country [1]
315964
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Australia
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Date submitted for ethics approval [1]
315964
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03/09/2024
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Approval date [1]
315964
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Ethics approval number [1]
315964
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Summary
Brief summary
This study aims to investigate the feasibility and acceptability of patient initiated follow-up (PIFU) following surgery for low risk endometrial cancer. Who is it for? You may be eligible for this study if you are a woman aged 18 years or over who has completed definitive primary surgical treatment for endometrial endometrioid adenocarcinoma, and has been assessed by a gynaecological oncology multidisciplinary team as having low risk disease in whom adjuvant therapy is not indicated. Study details Participants will be randomly allocated to PIFU, or standard of care follow up 6-monthly with the patient's General Practitioner. In the PIFU group, participants will receive an education session at baseline regarding when and how to contact the gynaecologic oncology service. Data will be collected on how many women on PIFU refer themselves back to the clinic. All participants will be followed up at 12 months post-baseline to conduct quality of life measures and cancer recurrence rates will be assessed. It is hoped that findings from this study inform a larger trial in future to assess healthcare costs and long term cancer outcomes associated with PIFU in endometrial cancer.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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A/Prof Emma Allanson
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Address
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Western Australia Gynaecological Cancer Service, King Edward Memorial Hospital, 374 Bagot Road, Subiaco, WA 6008
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Country
136366
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Australia
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Phone
136366
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+61 8 6458 1164
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Fax
136366
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Email
136366
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emma.allanson@health.wa.gov.au
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Contact person for public queries
Name
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A/Professor Emma Allanson
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Address
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Western Australia Gynaecological Cancer Service, King Edward Memorial Hospital, 374 Bagot Road, Subiaco, WA 6008
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Country
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Australia
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Phone
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+61 8 6458 1164
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Fax
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Email
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emma.allanson@health.wa.gov.au
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Contact person for scientific queries
Name
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A/Professor Emma Allanson
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Address
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Western Australia Gynaecological Cancer Service, King Edward Memorial Hospital, 374 Bagot Road, Subiaco, WA 6008
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Country
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Australia
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Phone
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+61 8 6458 2222
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Fax
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Email
136368
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emma.allanson@health.wa.gov.au
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
24154
Informed consent form
388327-(Uploaded-03-09-2024-15-40-20)-PECAN PICF 20 August 2024.pdf
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.
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