Clinical trial · Interventional
NODE (groiN ultrasOunD cancEr)
Randomised Feasibility Study of Groin Ultrasound Surveillance to De-Escalate Surgical Intervention in Women With Vulvar Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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 for 12 months.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Groin Node | — | UNRESOLVED | — |
| Lymph Node Metastasis | — | UNRESOLVED | — |
| Ultrasound Therapy; Complications | — | UNRESOLVED | — |
| Vulvar Cancer Stage Ib | Malignant Vulvar Neoplasm | CURATED_BROADER | 0.78 |
| Vulvar Cancer Stage II | Malignant Vulvar Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| High-resolution bilateral groin ultrasound surveillance | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Participants with normal/negative baseline groin ultrasounds
- description
- Interventional Treatment: serial high-resolution bilateral groin ultrasound surveillance in conjunction with clinical examinations every 2 months (n=13).
- interventionNames
- Diagnostic Test: High-resolution bilateral groin ultrasound surveillance
- type
- NO_INTERVENTION
- label
- Participants with normal/negative baseline groin ultrasounds - Standard Care
- description
- Standard Treatment: receive upfront full groin LND or sentinel node biopsy (SNB) based on clinician choice (according to local clinical practice management guidelines) (n=7).
- type
- NO_INTERVENTION
- label
- Participants with suspicious/indeterminate baseline groin ultrasound
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Women, over 18 years, with histologically confirmed SCC or adenocarcinoma 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) * 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
References
Publications (0)
Data not yet available