De status van het micromilieu van de (schildwacht)klieren en tumor bij patiënten met HPV-positieve en HPV-negatieve kanker van de schaamlippen.

• Conditions: Vulvar cancerLymph nodesHPVVulvacarcinoomLymfeklierenHPV

• Registration Number: NL-OMON25060
• Lead Sponsor: KI-AV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Other
• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

Age ≥ 18 years at start of the study;

- Primary carcinoma of the vulva with an indication for sentinel node procedure or inguinofemoral
lymphadenectomy;

Exclusion Criteria

- Patiënts who had previous therapy for macro invasive vulvar cancer (including sentinel node procedure) will not
participate in the sentinel node part of the study.

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To analyse the microenvironment of (S)LNs and PT (i.e. various T-cell populations, antigen presenting cells and myeloid suppressor cells) and other immune factors produced by the tumour cells in patients with vulvar cancer.

Secondary Outcome Measures

Name	Time	Method
- to assess the differences of the microenvironment in HPV-positive and HPV-negative (S)LNs<br /><br>- to assess the difference of the microenvironment of tumour-negative and metastatic (S)LNs.<br /><br>- to assess the difference of the microenvironment of SLNs and non-SLNs.<br /><br><br /><br>Exploratory objectives:<br /><br>- to analyse the difference in the (S)LNs compared to the PT. <br>