HPV in Sentinel Lymph Nodes

Cervical Cancer Clinical Trial

Official title:

HPV-testing of Sentinel Lymph Node Tissue From Cervical Cancer Patients.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03749707
• Other study ID #: SLN2018
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: June 30, 2022

Study information

• Verified date: November 2018
• Source: University of Aarhus
• Contact: Sara Bønløkke Simonsen
• Phone: 0045 53372162
• Email: sarasim[@]clin.au.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: June 30, 2022
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Woman > 18 years of age diagnosed with cervical cancer and admitted for surgery with radical hysterectomy and removal of SLNs between October 2018 and June 2022.

Exclusion Criteria:

• Woman < 18 years

• Women with late-stage cervical cancer, who are treated with radio- and chemotherapy.

Related Conditions & MeSH terms

• Cervical Cancer
• HPV-Related Cervical Carcinoma
• Sentinel Lymph Node
• Uterine Cervical Neoplasms

Intervention

Diagnostic Test:
• HPV analysis
HPV analysis of SLNs

Locations

Country	Name	City	State
Denmark	Department of Obstetrics and Gynecology	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HPV	The presence of HPV in SLNs	0 hours post-operation