No registrations found.
ID
Source
Brief title
Health condition
Vulvar cancer
Lymph nodes
HPV
Vulvacarcinoom
Lymfeklieren
HPV
Sponsors and support
Intervention
Outcome measures
Primary outcome
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
- 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.
Background summary
This is an exploratory study to further delineate the microenvironment of the primary tumour and (sentinel) lymph nodes (SLN) in HPV-positive and HPV-negative vulvar cancer. All patients diagnosed with vulvar carcinoma who will undergo a sentinel node procedure or a lymphadenectomy/lymph node debulking will be asked to participate in the study. 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) excision of the tumour (if applicable) on the operation room. In case only a lymph node dissection/debulking and no local excision of the tumour will be performed, the patient will be asked permission to obtaina small tumour biopsy on the operation room.
Study objective
This is an exploratory study to further delineate the microenvironment of the PT and (S)LNs in HPV-positive and HPV-negative vulvar cancer.
Study design
All interventions will be performed on the same day
Intervention
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) excision of the tumour (if applicable) on the operation room. In case only a lymph node dissection/debulking and no local excision of the tumour will be performed, the patient will be asked permission to perform a small tumour biopsy on the operation room.
Different subsets of the antigen presenting cells and other immune cells in the microenvironment will be measured by the use of multi-color flow cytometry and multi-parameter immunohistochemistry.
Jossie Rotman
Obstetrics & Gynecology/Immunotherapy Lab
Amsterdam
The Netherlands
(020-44)42175 Mob: +31622706702
Mail: j.rotman@vumc.nl
Jossie Rotman
Obstetrics & Gynecology/Immunotherapy Lab
Amsterdam
The Netherlands
(020-44)42175 Mob: +31622706702
Mail: j.rotman@vumc.nl
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
- 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
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL6843 |
NTR-old | NTR7021 |
CCMO | NL61965.031.17 |
OMON | NL-OMON44257 |