Efficacy of staging by sentinel lymph node procedure in vulvar cancer.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON29393

Enrollment

400

Registered

2005-08-22

Start date

2005-11-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vulvar cancer.

Interventions

None: observational study.

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with histologically proven T1 or T2 (FIGO) tumor <4 cm and not reaching urethra, vagina or anus with clinically negative inguinofemoral lymphnodes; 2. Injection of radio-isotope is possible; 3. Informed consent is possible.

Exclusion criteria

Exclusion criteria: 1. Inoperable tumors and tumors >4 cm; 2. Patient with chemically suspect lymph nodes or cytologically proven lymphnode metastases; 3. Multifocal tumors.

Design outcomes

Secondary

Measure	Time frame
Morbidity of the procedure and safety of frozen section multiple sectioning and immunohistochemistry in detecting lymphnode metastases.	—

Primary

Measure	Time frame
Outcome and relapse rates in two year follow-up.	—

Contacts

Public ContactM. Vonk

University Hospital Groningen, Department of Gynecologic Oncology, P.O. Box 30001

+31 (0)50 3616161

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)