HPV in Sentinel Lymph Nodes
Primary Purpose
Cervical Cancer, Sentinel Lymph Node, HPV-Related Cervical Carcinoma
Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
HPV analysis
Sponsored by
About this trial
This is an interventional prevention trial for Cervical Cancer focused on measuring HPV, Cervical cancer, SLN
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.
Sites / Locations
- Department of Obstetrics and GynecologyRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
SLNs from early-stage cervical cancer patients
Arm Description
Tissue from SLNs removed from early-stage cervical cancer patients are analyzed for HPV.
Outcomes
Primary Outcome Measures
HPV
The presence of HPV in SLNs
Secondary Outcome Measures
Full Information
NCT ID
NCT03749707
First Posted
November 19, 2018
Last Updated
November 19, 2018
Sponsor
University of Aarhus
1. Study Identification
Unique Protocol Identification Number
NCT03749707
Brief Title
HPV in Sentinel Lymph Nodes
Official Title
HPV-testing of Sentinel Lymph Node Tissue From Cervical Cancer Patients.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
January 31, 2022 (Anticipated)
Study Completion Date
June 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer, Sentinel Lymph Node, HPV-Related Cervical Carcinoma
Keywords
HPV, Cervical cancer, SLN
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Early-stage cervical cancer patients treated with radical hysterectomy and removal of SLNs.
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SLNs from early-stage cervical cancer patients
Arm Type
Other
Arm Description
Tissue from SLNs removed from early-stage cervical cancer patients are analyzed for HPV.
Intervention Type
Diagnostic Test
Intervention Name(s)
HPV analysis
Intervention Description
HPV analysis of SLNs
Primary Outcome Measure Information:
Title
HPV
Description
The presence of HPV in SLNs
Time Frame
0 hours post-operation
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Early-stage cervical cancer patients admitted for surgery with radical hysterectomy and removal of SLNs.
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sara Bønløkke Simonsen
Phone
0045 53372162
Email
sarasim@clin.au.dk
Facility Information:
Facility Name
Department of Obstetrics and Gynecology
City
Aarhus
ZIP/Postal Code
8200
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sara Bønløkke Simonsen
Phone
0045 53372162
Email
sarasim@clin.au.dk
First Name & Middle Initial & Last Name & Degree
Katrine Fuglsang, PhD
Phone
0045 23390224
Email
katrfugl@rm.dk
12. IPD Sharing Statement
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HPV in Sentinel Lymph Nodes
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