HPV in Sentinel Lymph Nodes of Cervical Cancer Patients
NCT03749707 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 127
Last updated 2025-04-01
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.
Conditions
- Cervical Cancer
- Sentinel Lymph Node
- HPV-Related Cervical Carcinoma
Interventions
- DIAGNOSTIC_TEST
-
HPV analysis
HPV analysis of SLNs with an in-house targeted Next Generation Sequencing assay
Sponsors & Collaborators
-
University of Aarhus
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-10-01
- Primary Completion
- 2023-12-31
- Completion
- 2023-12-31
Countries
- Denmark
Study Locations
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