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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
Sponsor:
Information provided by (Responsible Party):
University of Aarhus

Brief 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.


Condition or disease Intervention/treatment Phase
Cervical Cancer Sentinel Lymph Node HPV-Related Cervical Carcinoma Diagnostic Test: HPV analysis Not Applicable

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 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: N/A
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)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. HPV [ Time Frame: 0 hours post-operation ]
    The presence of HPV in SLNs



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Early-stage cervical cancer patients admitted for surgery with radical hysterectomy and removal of SLNs.
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03749707


Contacts
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Contact: Sara Bønløkke Simonsen 0045 53372162 sarasim@clin.au.dk

Locations
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Denmark
Department of Obstetrics and Gynecology Recruiting
Aarhus, Denmark, 8200
Contact: Sara Bønløkke Simonsen    0045 53372162    sarasim@clin.au.dk   
Contact: Katrine Fuglsang, PhD    0045 23390224    katrfugl@rm.dk   
Sponsors and Collaborators
University of Aarhus
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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT03749707    
Other Study ID Numbers: SLN2018
First Posted: November 21, 2018    Key Record Dates
Last Update Posted: November 21, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Aarhus:
HPV
Cervical cancer
SLN
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female