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

The state of the (sentinel) lymph node and tumour microenvironment in patients with HPV-positive and HPV-negative vulvar cancer.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON25060
Enrollment
100
Registered
2017-12-21
Start date
2018-02-01
Completion date
Unknown
Last updated
2024-06-11

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

Conditions

Vulvar cancer Lymph nodes HPV Vulvacarcinoom Lymfeklieren HPV

Interventions

Patients who will undergo a lymphadenectomy will be asked to participate in detecting the SLNs prior to the lymph node dissection by injecting patent blue in the tumour margins before the (local) exci

Sponsors

NKI-AVL
Lead Sponsor

Eligibility

Inclusion criteria

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; - Operation at the NKI-AVL or AMC/VUmc; - Signed informed consent.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
- to assess the differences of the microenvironment in HPV-positive and HPV-negative (S)LNs - to assess the difference of the microenvironment of tumour-negative and metastatic (S)LNs. - to assess the difference of the microenvironment of SLNs and non-SLNs. Exploratory objectives: - to analyse the difference in the (S)LNs compared to the PT.

Contacts

Public ContactJossie Rotman

VUmc-Cancer Center Amsterdam, CCA 2 - 48

Mail: j.rotman@vumc.nl(020-44)42175 Mob: +31622706702

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)