Impact of HPV on a Cohort of Southern Italian Women: Epidemiological, Clinical, Morphological and Microbiological Features

NCT ID: NCT03959410

Last Updated: 2023-04-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-04

Study Completion Date

2022-01-01

Brief Summary

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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

Detailed Description

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Conditions

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Cervix Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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HPV-positive patients

Patients who are positive for HPV DNA test

Group Type ACTIVE_COMPARATOR

Cervical biopsy

Intervention Type DIAGNOSTIC_TEST

in office Cervical biopsy

HPV-positive patients - Echinacea

Group Type ACTIVE_COMPARATOR

Cervical biopsy

Intervention Type DIAGNOSTIC_TEST

in office Cervical biopsy

HPV-positive patients - Standard

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Cervical biopsy

in office Cervical biopsy

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Women in fertile age

Exclusion Criteria

* severe comorbidities
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Campania Luigi Vanvitelli

OTHER

Sponsor Role lead

Responsible Party

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Prof. Pasquale De Franciscis

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Napoli, , Italy

Site Status

Countries

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Italy

Other Identifiers

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N.594

Identifier Type: -

Identifier Source: org_study_id

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