HPV in Sentinel Lymph Nodes of Cervical Cancer Patients

NCT ID: NCT03749707

Last Updated: 2025-04-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 127 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-01
• Study Completion Date: 2023-12-31

Brief Summary

This study examines sentinel lymph node tissue from early stage cervical cancer patients treated with radical surgery 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 patient's 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.

Detailed 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 surgery and removal of SLNs, and these lymph nodes are examined by means of the ultrastaging protocol (see https://www.sciencedirect.com/science/article/pii/S0090825821005126?via%3Dihub). In this study, we want to examine the remains from these analyzed SLNs. Ultrastaging entails cutting the SLNs in more sections and all levels of the lymph node, and these levels are subsequently histologically analysed 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 DNA by means of our in-house targeted Next Generation Sequencing panel (see https://febs.onlinelibrary.wiley.com/doi/10.1002/1878-0261.13538).

Conditions

Cervical Cancer; Sentinel Lymph Node; HPV-Related Cervical Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

SLNs from early-stage cervical cancer patients

Tissue from SLNs removed from early-stage cervical cancer patients are analyzed for HPV.

Group Type: OTHER

HPV analysis

Intervention Type: DIAGNOSTIC_TEST

HPV analysis of SLNs with an in-house targeted Next Generation Sequencing assay

Interventions

HPV analysis

HPV analysis of SLNs with an in-house targeted Next Generation Sequencing assay

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Department of Obstetrics and Gynecology

Aarhus, , Denmark

Countries

Denmark

Other Identifiers

SLN2018

Identifier Type: -

Identifier Source: org_study_id