Sentinel Node Extended in Squamous Cell Vulvar Cancer
NCT04147780 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 64
Last updated 2023-11-01
Summary
The aim of this study is to investigate the feasibility of sentinel node biopsy in patients with squamous cell vulvar cancer, currently not regarded suitable for the sentinel node technique, i.e. patients with tumors ≥4cm, multifocal tumors or locally recurrent disease. A positive result of this pilot study might constitute the basis for a future full-scale multinational trial.
Conditions
- Vulva Cancer
- Sentinel Lymph Node
Interventions
- PROCEDURE
-
Sentinel node biopsy
Sentinel node biopsy, radiotracer (mandatory) and blye dye (optional). Scintigraphy.
Sponsors & Collaborators
-
Sahlgrenska University Hospital
collaborator OTHER -
University Hospital, Linkoeping
collaborator OTHER -
Skane University Hospital
collaborator OTHER -
Diana Zach
lead OTHER
Principal Investigators
-
Diana Zach, MD · Karolinska University Hospital, Karolinska Institute, Stockholm, Sweden
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-12-14
- Primary Completion
- 2022-12-14
- Completion
- 2023-02-15
Countries
- Sweden
Study Locations
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