Clinical trial · Observational
Observation in Patients With Early-Stage Vulvar Cancer Undergoing Sentinel Lymph Node Dissection
GROningen INternational Study on Sentinel Nodes in Vulvar Cancer (GROINSS-V) II: An Observational Study
NCT01500512CI-TRIAL-00054190GROINSS-VunknownClinicalTrials.gov clinicaltrialsProvenance
- 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 research trial studies patients with early-stage vulvar cancer undergoing sentinel lymph node dissection. Sentinel lymph node dissection may have fewer side effects than removing all lymph nodes. Observing patients undergoing sentinel lymph node dissection may help doctors confirm the safety of the procedure.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Stage III Vulvar Cancer | Malignant Vulvar Neoplasm | CURATED_BROADER | 0.78 |
| Stage II Vulvar Cancer | Malignant Vulvar Neoplasm | CURATED_BROADER | 0.78 |
| Stage I Vulvar Cancer | Malignant Vulvar Neoplasm | CURATED_BROADER | 0.78 |
| Vulvar Squamous Cell Carcinoma | Vulvar Squamous Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Clinical Observation | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Observation (observe patients undergoing SLN dissection)
- description
- Patients receive standard therapy including sentinel lymph node dissection. Patients are then observed to collect information about treatment and outcomes every 2 months for 2 years.
- interventionNames
- Other: Clinical Observation
Primary outcomes (1)
- measure
- Safety of sentinel lymph node dissection
- timeFrame
- Up to 2 years
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must have squamous cell carcinoma with a depth invasion \> 1 mm * Patients must have T1 or T2 tumors (International Federation of Gynecology and Obstetrics\[FIGO\] staging), \< 4 cm, not encroaching in urethra, vagina, or anus with clinically negative inguinofemoral lymph nodes * Localization and size of the tumor are such that peri-lesional injection of the tracers at three or four sites is possible * Preoperative imaging do not show enlarged (\< 1.5 cm) suspicious nodes * Patients must sign informed consent Exclusion Criteria: * Inoperable tumors with diameter \> 4 cm * 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 * Patients with multifocal tumors * Patients who are currently on an investigational drug for the treatment of vulvar cancer are excluded from participation in this trial
References
Publications (0)
Data not yet available
No reference posted for this study.