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Clinical Trials/ACTRN12622000886785
ACTRN12622000886785Recruiting未知

Feasibility of Groin Ultrasound to Predict Groin Lymph Node Involvement in Patients with Histologically Proven Vulvar Cancer

niversity of Queensland0 sites100 target enrollmentStarted: June 22, 2022Last updated:
Conditions

Trial Snapshot

Phase
未知
Status
Recruiting
Sponsor
Enrollment
100

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional
Allocation
Non-randomised trial
Primary Purpose
Diagnosis
Masking
Open (masking not used)

Eligibility Criteria

Ages
18 Years to o limit (—)
Sex
Female

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.

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.

Investigators

Sponsor
niversity of Queensland

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