HPV in Sentinel Lymph Nodes
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|ClinicalTrials.gov Identifier: NCT03749707|
Recruitment Status : Recruiting
First Posted : November 21, 2018
Last Update Posted : November 21, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Cervical Cancer Sentinel Lymph Node HPV-Related Cervical Carcinoma||Diagnostic Test: HPV analysis||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Early-stage cervical cancer patients treated with radical hysterectomy and removal of SLNs.|
|Masking:||None (Open Label)|
|Official Title:||HPV-testing of Sentinel Lymph Node Tissue From Cervical Cancer Patients.|
|Actual Study Start Date :||October 1, 2018|
|Estimated Primary Completion Date :||January 31, 2022|
|Estimated Study Completion Date :||June 30, 2022|
SLNs from early-stage cervical cancer patients
Tissue from SLNs removed from early-stage cervical cancer patients are analyzed for HPV.
Diagnostic Test: HPV analysis
HPV analysis of SLNs
- HPV [ Time Frame: 0 hours post-operation ]The presence of HPV in SLNs
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03749707
|Contact: Sara Bønløkke Simonsen||0045 firstname.lastname@example.org|