Ultrasound Therapy; Complications Clinical Trial
— NODEOfficial title:
Randomised Feasibility Study of Groin Ultrasound Surveillance to De-Escalate Surgical Intervention in Queensland Women With Vulvar Cancer
This study is an open label, prospective, experimental, randomised clinical trial. The primary aim of this study is to determine whether it is feasible to randomise vulvar cancer patients into one of two treatment arms:1) surgical groin node dissection (as delivered though either a sentinel node biopsy or inguinofemoral lymph node dissection (IFL), or 2) serial high-resolution bilateral groin ultrasound surveillance and clinical examination every 2 months.
Status | Not yet recruiting |
Enrollment | 30 |
Est. completion date | March 31, 2028 |
Est. primary completion date | March 31, 2026 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Women, over 18 years, with histologically confirmed SCC, adenocarcinoma or melanoma of the vulva - Clinically stage I or II on medical imaging (CT scan of pelvis, abdomen, and chest), without evidence of regional or distant metastatic disease - Participant must be suitable to undergo IFL/SNB according to local clinical practice management guidelines - Signed written informed consent - Negative serum pregnancy test = 30 days of surgery in pre-menopausal women and women < 2 years after the onset of menopause - Patient lives within 40 km of a medical diagnostic imaging centre (site investigator approval required for special circumstances) Exclusion Criteria: - Women with non-invasive vulvar conditions (e.g. non-invasive non-mammary Paget's disease) - Squamous cell carcinoma (SCC) of the vulva 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 |
Country | Name | City | State |
---|---|---|---|
Australia | Royal Brisbane and Women's Hospital | Brisbane | Queensland |
Australia | St Andrew's War Memorial Hospital | Brisbane | Queensland |
Lead Sponsor | Collaborator |
---|---|
Queensland Centre for Gynaecological Cancer | Royal Brisbane and Women's Hospital |
Australia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Feasibility of randomisation: The percentage of patients willing to be randomised to either surgical groin node dissection or serial high-resolution bilateral groin ultrasound surveillance in conjunction with clinical examination every 2 months. | The feasibility of randomisation into (1) LND (IFL vs SNB) or (2) high-resolution bilateral groin ultrasound surveillance every 2 months will be determined through a practical sample size of n=20. Feasibility is declared if 30% of eligible patients (n=6 or more) can be randomised. | 12 months | |
Secondary | Utility of tumour mutations to determine positive lymph node metastasis. | Translational research - Compare the molecular profile of tumour mutations between positive and negative lymph nodes. | Study duration up to 15 years | |
Secondary | Utility of circulating tumour DNA to determine positive lymph node metastasis. | Translational research - Compare the molecular profile of circulating tumour DNA between positive and negative lymph nodes. | Study duration up to 15 years | |
Secondary | Utility of plasma to determine positive lymph node metastasis. | Translational research - Compare the molecular profile of plasma between positive and negative lymph nodes. | Study duration up to 15 years | |
Secondary | Utility of serum to determine positive lymph node metastasis. | Translational research - Compare the molecular profile of serum between positive and negative lymph nodes. | Study duration up to 15 years |
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