This is an exploratory study to further delineate the microenvironment of the PT and (S)LNs in HPV-positive and HPV-negative vulvar cancer.
ID
Bron
Verkorte titel
Aandoening
Vulvar cancer
Lymph nodes
HPV
Vulvacarcinoom
Lymfeklieren
HPV
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
This is an exploratory study to further delineate the microenvironment of the PT and (S)LNs in HPV-positive and HPV-negative vulvar cancer.
Onderzoeksopzet
All interventions will be performed on the same day
Onderzoeksproduct en/of interventie
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.
Publiek
Jossie Rotman
Obstetrics & Gynecology/Immunotherapy Lab
Amsterdam
The Netherlands
(020-44)42175 Mob: +31622706702
Mail: j.rotman@vumc.nl
Wetenschappelijk
Jossie Rotman
Obstetrics & Gynecology/Immunotherapy Lab
Amsterdam
The Netherlands
(020-44)42175 Mob: +31622706702
Mail: j.rotman@vumc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- 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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- 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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL6843 |
NTR-old | NTR7021 |
CCMO | NL61965.031.17 |
OMON | NL-OMON44257 |