Back to resultsImpact of HPV on a Cohort of Southern Italian Women: Epidemiological, Clinical, Morphological and Microbiological Features
Primary Purpose
Cervix Cancer
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Cervical biopsy
Sponsored by
About this trial
This is an interventional supportive care trial for Cervix Cancer focused on measuring hpv, cervical cancer, microbiome
Eligibility Criteria
Inclusion Criteria:
- Women in fertile age
Exclusion Criteria:
- severe comorbidities
Sites / Locations
- Department of Woman, Child and General and Specialized Surgery, University of Campania "Luigi Vanvitelli"
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
No Intervention
Arm Label
HPV-positive patients
HPV-positive patients - Echinacea
HPV-positive patients - Standard
Arm Description
Patients who are positive for HPV DNA test
Outcomes
Primary Outcome Measures
Evaluation of Cervical microbiome
Secondary Outcome Measures
Full Information
NCT ID
NCT03959410
First Posted
May 21, 2019
Last Updated
April 11, 2023
Sponsor
University of Campania "Luigi Vanvitelli"
1. Study Identification
Unique Protocol Identification Number
NCT03959410
Brief Title
Impact of HPV on a Cohort of Southern Italian Women: Epidemiological, Clinical, Morphological and Microbiological Features
Official Title
Impact of HPV on a Cohort of Southern Italian Women: a Prospective Observational Study About Epidemiological, Clinical, Morphological and Microbiological Features of HPV Infection
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
January 4, 2019 (Actual)
Primary Completion Date
December 10, 2021 (Actual)
Study Completion Date
January 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Campania "Luigi Vanvitelli"
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
HPV is known to be the causal agent in the majority of cervical cancers. However, the role of the cervical bacterial microbiome in cervical cancer is not clear
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervix Cancer
Keywords
hpv, cervical cancer, microbiome
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HPV-positive patients
Arm Type
Active Comparator
Arm Description
Patients who are positive for HPV DNA test
Arm Title
HPV-positive patients - Echinacea
Arm Type
Active Comparator
Arm Title
HPV-positive patients - Standard
Arm Type
No Intervention
Intervention Type
Diagnostic Test
Intervention Name(s)
Cervical biopsy
Intervention Description
in office Cervical biopsy
Primary Outcome Measure Information:
Title
Evaluation of Cervical microbiome
Time Frame
12 months
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Women in fertile age
Exclusion Criteria:
severe comorbidities
Facility Information:
Facility Name
Department of Woman, Child and General and Specialized Surgery, University of Campania "Luigi Vanvitelli"
City
Napoli
ZIP/Postal Code
80122
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Impact of HPV on a Cohort of Southern Italian Women: Epidemiological, Clinical, Morphological and Microbiological Features
We'll reach out to this number within 24 hrs