The state of the (sentinel) lymph node and tumour microenvironment in patients with cancer of the cervix.

Cervical cancer is the fourth most common cancer worldwide. When treatment
consists of an operation, pelvic lymph nodes are removed to detect the presence
of metastases. Sentinel lymph node(s) are the first lymph nodes that are under
the influence of tumour-derived factors and in which an immune response can be
generated by the activation of naive T and B cells. Thus the state of the
sentinel lymph node microenvironment is critical in the initial decision
between activation and suppression of the immune system by the primary tumour.
A better understanding of the microenvironment of the cervical sentinel lymph
node is therefore critical for the development of new immunotherapeutic
strategies. Also non sentinel lymph node(s) can be influenced in their
microenvironment, due to draining tumour derived factors from the SLNs.

The primary objective of this study is to analyse the microenvironment of the
primary tumour and sentinel and non-sentinel lymph node(s) (i.e. various T-cell
populations, antigen presenting cells and myeloid-derived suppressor cells) in
patients with cervical carcinoma.
The secondary objectives of this study are to assess the differences of the
microenvironment in tumour-negative and metastatic sentinel lymph node(s).
Exploratory objectives of this study are to analyse the differences in
microenvironment in (sentinel) lymph nodes and to analyse the difference in the
(sentinel) lymph nodes compared to the primary tumour. Also, the systemic
immunity will be determined by the analysis of the peripheral blood in patients
with cervical cancer.

This is an exploratory study to further delineate the microenvironment of the
primary tumour and (sentinel) lymph nodes in cervical cancer.

The isolation of lymph node cell samples via scrapings of the longitudinal
cutting edges of lymph nodes that are processed for diagnosis may carry a very
small risk for a false-negative diagnosis for the presence of metastases in
lymph nodes because a little bit of lymph node material is removed before the
lymph node is processed according to standard procedures. Notably, a surgically
dissected lymph node is cut through the longitudinal axis as part of the
standard procedures in the department of Pathology. Then the lymph node is
paraffin embedded. From each half only one section is taken for diagnosis. The
section used for diagnosis follows the cutting of several sections, a procedure
which is needed to have an optimal section cut off the embedded lymph node. It
should be appreciated that there is always loss of lymph node material before a
diagnosis can be made. Also in case of a sentinel lymph node procedure only a
few sections are used for diagnosis. This indicates that there will always be a
small risk for a false negative diagnosis. The department of Pathology
considers the chance of missing a metastasis in a lymph node by introduction of
scraping the cutting edge of the lymph nodes very small, but they cannot
exclude it. There are no direct benefits for participating patiënts.

Patiënts will be asked to donate 2x 10 ml blood for further analysis (at two
different timepoints).

In case of a lymph node debulking, a small tumour biopsy will be performed on
the surgery room. This carries a small risk of infection/bleeding, but as the
patient will be hospitalized for a couple of days, this can be adequately
monitored and/or treated.

When injecting patent blue into the tumor for detecting sentinel lymph node(s)
there is a very small change for the patiënt to develop an allergic reaction
(1-2%)..