Cervical Cancer Clinical Trial
Official title:
HPV-testing of Sentinel Lymph Node Tissue From Cervical Cancer Patients.
This study examines sentinel lymph node tissue from early stage cervical cancer patients
treated with radical hysterectomy and removal of pelvic sentinel lymph nodes (SLN). SLNs are
tested for the presence of human papilloma virus (HPV), and results are compared to the
HPV-type found in the patients cervical tissue.
We hereby examine whether pathologic status of SLNs in patients with early-stage cervical
cancer correlates to the HPV status in the SLNs. By means of an up to 5-years follow-up
period, we furthermore examine whether cervical cancer recurrence correlates to the
histopathologic status of the SLNs and/or the SLN HPV status. This will contribute to the
clarification on whether HPV status of the SLNs plays a crucial role for predicting LN
metastasis of cervical cancer and also, whether the HPV status in SLNs may have a clinical
value as a prognostic factor for disease recurrence in cervical cancer patients and perhaps
even a better clinical value than SLN mapping.
The aim of the study is to examine whether the pathologic status of SLNs in patients with
early-stage cervical cancer correlates to the HPV status in the SLNs and also, whether
cervical cancer recurrence correlates to the histopathologic status of the SLNs and/or the
SLN HPV status.
In Denmark, staging and treatment of cervical cancer are performed according to the
recommendations of the International Federation of Gynecology and Obstetrics (FIGO). Cervical
cancer is the only gynecological cancer that is clinically based on tumor size, vaginal or
parametrial involvement, bladder/rectum extension and distant metastases. It requires
examination under anesthesia and imaging, which in Denmark includes positron emission
computed tomography (PET-CT) to detect pathological lymph nodes (LNs) and to accurately
delineate the extent of the disease and magnetic resonance imaging (MRI) to determine tumor
size, degree of stromal penetration, parametrial involvement, vaginal and corpus extension.
Tumor risk assessment includes tumor size, stage, depth of tumor invasion, LN status,
lymphovascular space invasion (LVSI) and histological subtype, of which LN status and number
of LNs involved are the most important prognostic factors. In Denmark, patients at FIGO
stages 1B1 to 2A undergo radical hysterectomy and radical pelvic lymphadenectomy (PL), and
they are offered adjuvant oncological treatment with radiotherapy and concomitant
chemotherapy if specific risk factors are present. A national protocolled study on the
implementation of SLN mapping in women with early-stage cervical cancer is currently being
conducted in Denmark at Rigshospitalet, Odense University Hospital and Aarhus University
Hospital (The Sentirec study). In this study, we want to examine the remains from these
analyzed SLNs. According to the Sentirec protocol, SLNs are examined by means of
ultrastaging, which entails cutting the SLNs in more sections and all levels of the LN and
examining these levels histologically by an experienced pathologist. In this study, we
examine the remains from the SLNs; that is the sections between the tissue used for SLN
mapping. These sections are analyzed for HPV.
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