HPV in Sentinel Lymph Nodes of Cervical Cancer Patients

NCT03749707 | Completed

• 1 other identifier: SLN2018
• Study Type: interventional
• Target: 127
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

HPV; Cervical cancer; SLN

Outcome Measures

Primary Outcomes (1)

• HPV

  The presence of HPV in SLNs

  0 hours post-operation

Study Arms (1)

SLNs from early-stage cervical cancer patients

OTHER

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

Diagnostic Test: HPV analysis

Interventions

HPV analysis DIAGNOSTIC_TEST

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

SLNs from early-stage cervical cancer patients

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Early-stage cervical cancer patients admitted for surgery with radical surgery and removal of SLNs.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Woman \< 18 years
• Women with late-stage cervical cancer, who are treated with radio- and chemotherapy.

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Department of Obstetrics and Gynecology

Aarhus, 8200, Denmark

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Early-stage cervical cancer patients treated with radical surgery and removal of SLNs.

Study Record Dates

• First Submitted: November 19, 2018
• First Posted: November 21, 2018
• Study Start: October 1, 2018
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: April 1, 2025

Record last verified: 2024-01

Locations

DK (1)