NCT03959410

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 4, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 21, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 22, 2019

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2021

Completed
22 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

April 13, 2023

Status Verified

April 1, 2023

Enrollment Period

2.9 years

First QC Date

May 21, 2019

Last Update Submit

April 11, 2023

Conditions

Cervix Cancer

Keywords

hpvcervical cancermicrobiome

Outcome Measures

Primary Outcomes (1)

  • Evaluation of Cervical microbiome

    12 months

Study Arms (3)

HPV-positive patients

ACTIVE COMPARATOR

Patients who are positive for HPV DNA test

Diagnostic Test: Cervical biopsy

HPV-positive patients - Echinacea

ACTIVE COMPARATOR
Diagnostic Test: Cervical biopsy

HPV-positive patients - Standard

NO INTERVENTION

Interventions

Cervical biopsyDIAGNOSTIC_TEST

in office Cervical biopsy

HPV-positive patientsHPV-positive patients - Echinacea

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women in fertile age

You may not qualify if:

  • severe comorbidities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Woman, Child and General and Specialized Surgery, University of Campania "Luigi Vanvitelli"

Napoli, 80122, Italy

Location

MeSH Terms

Conditions

Uterine Cervical NeoplasmsPapillomavirus Infections

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesSexually Transmitted Diseases, ViralSexually Transmitted DiseasesCommunicable DiseasesInfectionsDNA Virus InfectionsVirus DiseasesTumor Virus InfectionsDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 21, 2019

First Posted

May 22, 2019

Study Start

January 4, 2019

Primary Completion

December 10, 2021

Study Completion

January 1, 2022

Last Updated

April 13, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)