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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06476639
Registration number
NCT06476639
Ethics application status
Date submitted
17/06/2024
Date registered
26/06/2024
Date last updated
26/06/2024
Titles & IDs
Public title
Australian National Vulvar Cancer Trial
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Scientific title
A Phase II Randomised Clinical Trial of Ultrasound Groin Monitoring Versus Groin Lymph Node Dissection to De-Escalate the Extent of Surgery in Vulvar Cancer
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Secondary ID [1]
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ANVU
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Universal Trial Number (UTN)
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Trial acronym
ANVU
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Vulvar Cancer Stage I
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Vulvar Cancer Stage II
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Lymph Node Metastasis
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Groin Node
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Ultrasound Therapy; Complications
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Condition category
Condition code
Cancer
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Other cancer types
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Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Diagnosis / Prognosis - High-resolution bilateral groin ultrasound monitoring
Experimental: Participants with normal/negative baseline groin ultrasounds - Intervention Group - Surgical removal of primary tumour and serial high-resolution bilateral groin ultrasound monitoring every 2 months and clinical examination every 3 months (n=120).
No intervention: Participants with normal/negative baseline groin ultrasounds - Standard Group - Surgical removal of primary tumour and upfront full groin LND or sentinel node biopsy (SNB) based on clinician choice (according to local clinical practice management guidelines).
No intervention: Participants with suspicious/indeterminate baseline groin ultrasound - Standard Treatment - Participants with suspicious/indeterminate baseline groin ultrasound (third group) will receive an upfront full groin LND or SNB, consistent with the current standard treatment, according to local clinical practice management guidelines.
Diagnosis / Prognosis: High-resolution bilateral groin ultrasound monitoring
Participants in the Interventional Group will undergo surgical excision of the primary tumor, either via radical wide local excision or radical vulvectomy. Post-vulvar surgery, participants will receive a groin node ultrasound every 2 months and a clinical examination every 3 months, for a follow up period of 12 months. Senior imaging specialists review bilateral ultrasound scans for positive lymph nodes or suspicious findings, promptly sending reports to the primary care physician and trial manager if detected within 3 business days. Subsequently, participants consult their primary care physician for options. Depending on clinical judgment, they may be referred for LND or continue with bi-monthly ultrasounds based on preference and clinician guidance.
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Intervention code [1]
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Diagnosis / Prognosis
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Incidence of enlarged clinically palpable groin nodes (groin metastases) in women with vulvar cancer randomised to serial high-resolution groin ultrasound monitoring compared to standard upfront surgical groin LND.
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Assessment method [1]
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Determine the incidence of palpable, fixed to skin and histologically positive groin nodes in women with vulvar cancer randomised to serial high-resolution groin ultrasound monitoring compared to standard upfront surgical groin LND.
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Timepoint [1]
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12 months after surgery
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Secondary outcome [1]
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Patient Reported Outcomes (PROMs)
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Assessment method [1]
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Compare PROMS between the groups, as measured by the EuroQoL-5D and FACT-V questionnaires, at baseline, 8 weeks, 6 months, and 12 months.
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Timepoint [1]
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12 months after surgery
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Secondary outcome [2]
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Health Related Quality of Life (HRQL)
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Assessment method [2]
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Compare HRQL between the groups, as measured by the EuroQoL-5D and FACT-V questionnaires at baseline, 8 weeks, 6 months and 12 months.
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Timepoint [2]
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12 months after surgery
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Secondary outcome [3]
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Pain
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Assessment method [3]
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Compare pain levels between the groups
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Timepoint [3]
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12 months after surgery
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Secondary outcome [4]
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Adverse events
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Assessment method [4]
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Compare adverse events between the groups
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Timepoint [4]
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12 months after surgery
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Secondary outcome [5]
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Lower limb lymphoedema
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Assessment method [5]
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Compare the incidence of lower limb lymphoedema between the groups
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Timepoint [5]
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12 months after surgery
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Secondary outcome [6]
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Cost-effectiveness
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Assessment method [6]
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Compare cost effectiveness between the groups
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Timepoint [6]
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12 months after surgery
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Secondary outcome [7]
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Disease-free survival
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Assessment method [7]
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Compare disease-free survival between the groups
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Timepoint [7]
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12 months after surgery
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Secondary outcome [8]
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Overall survival
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Assessment method [8]
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Compare overall survival between the groups
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Timepoint [8]
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12 months after surgery
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Secondary outcome [9]
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Clinical accuracy of high-resolution serial ultrasound to predict groin lymph node involvement
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Assessment method [9]
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Determine the diagnostic accuracy of pre-operative, standardised, high-resolution groin ultrasound to identify groin node metastasis
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Timepoint [9]
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12 months after surgery
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Secondary outcome [10]
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Utility of circulating tumour DNA to reliably reflect the presence or absence of positive groin lymph nodes
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Assessment method [10]
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Assess the role of circulating tumour DNA to accurately determine the burden of disease (positive lymph nodes) in vulvar cancer, assist with risk stratification and aid disease surveillance
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Timepoint [10]
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Study duration of up to 15 years
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Secondary outcome [11]
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Utility of plasma to reliably reflect the presence or absence of positive groin lymph nodes
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Assessment method [11]
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Assess the role of plasma to accurately determine the burden of disease (positive lymph nodes) in vulvar cancer, assist with risk stratification and aid disease surveillance
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Timepoint [11]
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Study duration of up to 15 years
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Secondary outcome [12]
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Utility of serum to reliably reflect the presence or absence of positive groin lymph nodes
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Assessment method [12]
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Assess the role of serum to accurately determine the burden of disease (positive lymph nodes) in vulvar cancer, assist with risk stratification and aid disease surveillance
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Timepoint [12]
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Study duration of up to 15 years
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Secondary outcome [13]
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Utility of tumour mutations to reliably reflect the presence or absence of positive groin lymph nodes
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Assessment method [13]
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Assess the role of tumour mutations to accurately determine the burden of disease (positive lymph nodes) in vulvar cancer, assist with risk stratification and aid disease surveillance
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Timepoint [13]
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Study duration of up to 15 years
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Eligibility
Key inclusion criteria
* Females, over 18 years, with histologically confirmed SCC, adenocarcinoma, or melanoma of the vulvar
* Clinically stage 1 or 2 on medical imaging (CT or MRI scan of pelvis, abdomen, and chest), without evidence of regional or distant metastatic disease
* Undergo IFL/SNB according to local clinical practice management guidelines
* Willing and able to comply with all study requirements, timing and/or nature of required assessments.
* Signed written informed consent
* Negative (serum or urine) pregnancy (BHCG) test = 30 days of surgery ONLY in pre-menopausal women and women < 2 years after the onset of menopause.
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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
* Women with non-invasive vulvar conditions (e.g. non-invasive non-mammary Paget's disease)
* SCC of the vulvar with depth of invasion =1 mm
* Clinical or medical imaging evidence of regional and/or distant metastatic disease
* Serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator)
* Other prior malignancies <5 years before inclusion, except for successfully treated keratinocyte skin cancers, or ductal carcinoma in situ
* Estimated life expectancy of =6 months
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Study design
Purpose of the study
Other
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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)
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Methods used to generate the sequence in which subjects will be randomised (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
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
1/04/2025
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/04/2029
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Actual
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Sample size
Target
240
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,NT,QLD,SA,TAS,VIC,WA
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Recruitment hospital [1]
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John Hunter Hospital - Newcastle
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Recruitment hospital [2]
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The Royal North Shore Hospital - Sydney
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Recruitment hospital [3]
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The Royal Darwin Hospital - Darwin
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Recruitment hospital [4]
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The Wesley Hospital - Auchenflower
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Recruitment hospital [5]
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Mater Hospital - Brisbane
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Recruitment hospital [6]
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St Andrew's War Memorial Hospital - Brisbane
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Recruitment hospital [7]
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Royal Brisbane and Women's Hospital - Brisbane
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Recruitment hospital [8]
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Buderim Private Hospital - Buderim
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Recruitment hospital [9]
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Royal Adelaide Hospital - Adelaide
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Recruitment hospital [10]
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Royal Hobart Hospital - Hobart
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Recruitment hospital [11]
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Mercy Hospital for Women - Heidelberg
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Recruitment hospital [12]
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Royal Women's Hospital - Parkville
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Recruitment hospital [13]
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St John of God Hospital - Subiaco
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Recruitment postcode(s) [1]
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2305 - Newcastle
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Recruitment postcode(s) [2]
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2065 - Sydney
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Recruitment postcode(s) [3]
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0810 - Darwin
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Recruitment postcode(s) [4]
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4066 - Auchenflower
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Recruitment postcode(s) [5]
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4000 - Brisbane
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Recruitment postcode(s) [6]
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4029 - Brisbane
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Recruitment postcode(s) [7]
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4556 - Buderim
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Recruitment postcode(s) [8]
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5000 - Adelaide
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Recruitment postcode(s) [9]
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7000 - Hobart
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Recruitment postcode(s) [10]
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3084 - Heidelberg
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Recruitment postcode(s) [11]
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3052 - Parkville
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Recruitment postcode(s) [12]
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6904 - Subiaco
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Funding & Sponsors
Primary sponsor type
Government body
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Name
Queensland Centre for Gynaecological Cancer
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Address
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Country
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Other collaborator category [1]
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Government body
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Name [1]
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Royal Brisbane and Women's Hospital
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
This study is a phase II, open label, multicentre, three-group, randomised clinical trial. The primary aim of this study is to determine whether intensive groin ultrasound monitoring (1) is effective and safe to replace invasive groin lymph node dissection (LND) to manage vulvar cancer, (2) decreases the morbidity associated with vulvar cancer surgery, and (3) is cost effective.
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Trial website
https://clinicaltrials.gov/study/NCT06476639
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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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Andreas Obermair, MD
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Address
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Director, Queensland Centre for Gynaecological Cancer Research
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Brianna Armstrong
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Address
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Country
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Phone
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07 3346 5063
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Fax
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Email
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[email protected]
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Contact person for scientific queries
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
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06476639
Download to PDF