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Trial registered on ANZCTR


Registration number
ACTRN12622000886785
Ethics application status
Approved
Date submitted
17/06/2022
Date registered
22/06/2022
Date last updated
2/05/2024
Date data sharing statement initially provided
22/06/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Feasibility of Groin Ultrasound to Predict Groin Lymph Node Involvement in Patients with Histologically Proven Vulvar Cancer
Scientific title
Feasibility of Groin Ultrasound to Predict Groin Lymph Node Involvement in Patients with Histologically Proven Vulvar Cancer
Secondary ID [1] 307381 0
None
Universal Trial Number (UTN)
Trial acronym
Pre-ANVU
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vulvar Cancer 326693 0
Condition category
Condition code
Cancer 323935 323935 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Groin ultrasound to assess groin lymph node involvement in patients with histologically proven vulvar cancer.

Eligible participants will receive a bilateral groin node ultrasound up to 30 days prior to planned surgery. The groin ultrasound will capture 6 variables of interest for each identified groin node on a study specific case report form: shape (globular vs non globular); homogeneity of echo structure; hyper- or hypoechoic areas within the lymph nodes; hilum abnormalities; cortical thickening; and nodal grouping

For the most suspicious or largest lymph node: long (L) and short (S) axis; L/S ratio (values of <2 are considered abnormal); cortical (C) and medullar (M) thickness; C/M ratio (values >1 are considered abnormal); perinodal hyperechoic ring (inflammation); cortical interruption (possibility of extra-nodal spread); nodal vascularity. An overall assessment will be made by the radiologist into normal, indeterminate or suspicious/positive.

All groin ultrasound examinations will be performed by registered sonographers recognised by the Australian Sonographers Accreditation Registry.

No preparation is required for a groin ultrasound. Examinations usually take between 30 and 45 minutes and participants will be given instructions on how to prepare for their ultrasound
examinations and what happens during the procedure and the sonographer will guide them
throughout the procedure. Participants will undergo a bilateral groin high-resolution ultrasound examination once only.

A Central Review of all ultrasound images will be used to ensure optimal quality and to monitor adherence to the intervention.
Intervention code [1] 323815 0
Diagnosis / Prognosis
Intervention code [2] 323827 0
Early detection / Screening
Comparator / control treatment
Standard treatment comprises surgical removal of the primary tumour plus surgical groin lymph node dissection (LND). Groin LND can be delivered through a full inguino-femoral node dissection (IFL) (removing as many nodes as possible) or through sentinel node biopsy (SNB -removing only one or two targeted groin lymph nodes).

All participants will receive a bilateral groin node ultrasound and subsequently will undergo surgery to the vulva and groin(s).
Control group
Active

Outcomes
Primary outcome [1] 331736 0
Feasibility of preoperative bilateral high-resolution groin ultrasound to diagnose groin node
involvement in women with vulvar cancer.

Six key features will be captured for each identified groin node on a study specific case report form (CRF/eCRF): shape (globular vs non globular); homogeneity of echo structure; hyper- or hypoechoic areas within the lymph nodes; hilum abnormalities; cortical thickening; and nodal grouping. For the most suspicious or largest lymph node: long (L) and short (S) axis; L/S ratio (values of <2 are considered abnormal); cortical (C) and medullar (M) thickness; C/M ratio (values >1 are considered abnormal); perinodal hyperechoic ring (inflammation); cortical interruption (possibility of extra-nodal
spread); nodal vascularity. An overall assessment will be made by the radiologist into normal, indeterminate or suspicious/positive. All participants subsequently will undergo surgery to the vulva and groin(s). The histopathological findings of the groin node dissection will be compared with the ultrasound findings and the accuracy of ultrasound in the detection of groin node involvement will be assessed.
Timepoint [1] 331736 0
Upon completion of the study
Secondary outcome [1] 410928 0
Utility of biomarkers to reliably reflect the presence or absence of involved groin lymph nodes. Participants have the option to provide samples for use in future translational research. We will collect blood samples from participants who consent at two time points, Baseline (pre-operatively) and 6 weeks after surgery to be banked for the purpose of future molecular and biomarker research into vulvar cancer. Each participant will be asked to donate three tubes of blood (approximately 37 mls) at their convenience. Participants’ blood samples will be collected for Germline DNA, Circulating tumour DNA, and Plasma and Serum. Participants can still participate in this study if they choose not to provide blood samples. For participants who have consented for the future use of blood samples, analyses will include examining circulating factors, such as extracellular vesicles and their contents.
Timepoint [1] 410928 0
Baseline - (pre-operative)

Eligibility
Key inclusion criteria
- Females, over 18 years, with histologically confirmed squamous cell carcinoma (SCC), adenocarcinoma or melanoma of the vulva
- Undergo inguino-femoral lymphadenectomy /sentinel node biopsy according to local clinical practice management guidelines
- Signed written informed consent
- Negative serum pregnancy test less than or equal to 30 days of surgery in pre-menopausal women and women < 2 years after the onset of menopause.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
- Women with non-invasive vulvar conditions (e.g. non-invasive non-mammary Paget’s disease)
- SCC of the vulva with depth of invasion less than or equal to 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.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The women subsequently will undergo surgery to the vulva and groin. The histopathological findings of the groin node dissection will be compared with the ultrasound findings and the accuracy of ultrasound in the detection of groin node involvement will be assessed.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/08/2022
Actual
17/08/2022
Date of last participant enrolment
Anticipated
30/06/2026
Actual
Date of last data collection
Anticipated
30/06/2026
Actual
Sample size
Target
100
Accrual to date
19
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 22575 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [2] 22576 0
Mater Adult Hospital - South Brisbane
Recruitment hospital [3] 22577 0
St Andrew's War Memorial Hospital - Brisbane
Recruitment hospital [4] 22578 0
The Wesley Hospital - Auchenflower
Recruitment postcode(s) [1] 37827 0
4029 - Herston
Recruitment postcode(s) [2] 37828 0
4101 - South Brisbane
Recruitment postcode(s) [3] 37829 0
4000 - Brisbane
Recruitment postcode(s) [4] 37830 0
4066 - Auchenflower

Funding & Sponsors
Funding source category [1] 311658 0
Other
Name [1] 311658 0
Queensland Centre for Gynaecological Cancer (QCGC) Research
Country [1] 311658 0
Australia
Primary sponsor type
University
Name
University of Queensland
Address
UQ Centre for Clinical Research, Building 71/918
Butterfield Street
Royal Brisbane and Women’s Hospital
Herston QLD 4029
Country
Australia
Secondary sponsor category [1] 313105 0
None
Name [1] 313105 0
Address [1] 313105 0
Country [1] 313105 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311115 0
The Prince Charles Hospital Human Research Ethics Committee
Ethics committee address [1] 311115 0
Building 14, The Prince Charles Hospital, Rode Road, Chermside, Qld 4032
Ethics committee country [1] 311115 0
Australia
Date submitted for ethics approval [1] 311115 0
28/02/2022
Approval date [1] 311115 0
07/04/2022
Ethics approval number [1] 311115 0
HREC/2022/QPCH/84516:
Ethics committee name [2] 311116 0
UnitingCare Human Research Ethics Committee
Ethics committee address [2] 311116 0
451 Coronation Drive, Auchenflower, QLD 4066
Ethics committee country [2] 311116 0
Australia
Date submitted for ethics approval [2] 311116 0
21/06/2022
Approval date [2] 311116 0
Ethics approval number [2] 311116 0

Summary
Brief summary
Standard treatment of vulvar cancer includes surgery to remove the primary tumour, and if required, removal of groin lymph nodes. Groin Lymph Node Dissection (LND) can be delivered through a full inguinofemoral node dissection (removing as many nodes as possible) or through sentinel node biopsy (SNB -removing only one or two targeted groin lymph nodes). While the gold standard is often curative, groin LND is associated with debilitating long-term outcomes for virtually all women. The aim of this study is to assess the feasibility and accuracy of using high-resolution groin ultrasound as a non-invasive alternative method of identifying lymph node involvement in these patients.

Who is it for?
You may be eligible for this study if you are aged 18 years and over, have been diagnosed with vulvar cancer (i.e. without evidence of regional or distant metastatic disease), and are scheduled to undergo surgery to the vulva and groin(s) within the next 30 days.

Study details
Up to 30 days prior to their planned surgery, all participants will undergo a bilateral (i.e. on both sides) groin ultrasound. This will involve a radiologist placing a small probe on the groin to take measurements of any identified lymph nodes, and will take between 30 and 45 minutes to complete. After their planned surgery, any removed lymph nodes will be assessed by a pathologist for detection of spread of vulvar cancer cells. This will then be compared to the ultrasound measurements to determine whether groin ultrasound can be used to predict nodal involvement.

It is hoped that this study may show that non-invasive groin ultrasound is a feasible and accurate method of predicting nodal involvement in vulvar cancer patients. If so, the ability to predict the absence of nodal involvement may spare future vulvar cancer patients unnecessary LND procedures to reduce complications, improve recovery time, and facilitate their return to normal daily activities.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 119990 0
Prof Andreas Obermair
Address 119990 0
Queensland Centre for Gynaecological Cancer (QCGC) Research
UQ Centre for Clinical Research, Building 71/918
Butterfield Street
Royal Brisbane and Women’s Hospital
Herston QLD 4029
Country 119990 0
Australia
Phone 119990 0
+6107 3346 5073
Fax 119990 0
Email 119990 0
[email protected]
Contact person for public queries
Name 119991 0
Avalon Knott
Address 119991 0
Queensland Centre for Gynaecological Cancer (QCGC) Research
UQ Centre for Clinical Research, Building 71/918
Butterfield Street
Royal Brisbane and Women’s Hospital
Herston QLD 4029
Country 119991 0
Australia
Phone 119991 0
+6107 3346 5063
Fax 119991 0
Email 119991 0
[email protected]
Contact person for scientific queries
Name 119992 0
Andreas Obermair
Address 119992 0
Queensland Centre for Gynaecological Cancer (QCGC) Research
UQ Centre for Clinical Research, Building 71/918
Butterfield Street
Royal Brisbane and Women’s Hospital
Herston QLD 4029
Country 119992 0
Australia
Phone 119992 0
+6107 3346 5073
Fax 119992 0
Email 119992 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
16412Ethical approval    384233-(Uploaded-17-06-2022-11-47-00)-Study-related document.pdf



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

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