GROningen INternational Study on Sentinel nodes in Vulvar cancer. An observational study.
Completed
- Conditions
- Squamous cell carcinoma of the vulva
- Registration Number
- NL-OMON23376
- Lead Sponsor
- Dutch Cancer Society (KWF Kankerbestrijding)
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 1500
Inclusion Criteria
1. Primary squamous cell carcinoma of the vulva < 4cm
2. Depth of invasion > 1mm;
3. Not encroaching in urethra, vagina or anus, and clinically negative inguinofemoral lymph nodes;
4. Preoperative imaging does not show enlarged (< 1.5 cm) / suspicious nodes;
5. Possibility to obtain informed consent.
Exclusion Criteria
1. Inoperable tumors and tumors with diameter > 4cm;
2. Patients with inguinofemoral lymph nodes, at palpation clinically suspect for metastases, at radiology enlarged (>1.5 cm) / suspicious groin nodes and with cytologically proven inguinofemoral lymph node metastases;
3. Patients with multifocal tumors.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Groin recurrence rate
- Secondary Outcome Measures
Name Time Method Treatment associated morbidity.