Impact of HPV on a Cohort of Southern Italian Women: Epid... | NCT03959410

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

NCT03959410

Sponsor

University of Campania Luigi Vanvitelli

Status

Completed

Last Update Posted

Apr 13, 2023Actual

Enrollment

150Actual

Phase

Not Applicable

Conditions

Cervix Cancer

Interventions

Cervical biopsy

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 4, 2019Actual

Primary Completion Date

Dec 10, 2021Actual

Completion Date

Jan 1, 2022Actual

First Submitted Date

May 21, 2019

First Submission Date that Met QC Criteria

May 21, 2019

First Posted Date

May 22, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 11, 2023

Last Update Posted Date

Apr 13, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Prof. Pasquale De Franciscis, Associate Professor, University of Campania Luigi VanvitelliPrincipal Investigator

Lead Sponsor

University of Campania Luigi VanvitelliOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

150Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Cervical biopsy	Diagnostic Test	in office Cervical biopsy	HPV-positive patients HPV-positive patients - Echinacea

Measure	Description	Time Frame
Evaluation of Cervical microbiome		12 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Women in fertile age

Exclusion Criteria:

severe comorbidities

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Woman, Child and General and Specialized Surgery, University of Campania "Luigi Vanvitelli"		Naples		80122	Italy

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002583	Uterine Cervical Neoplasms
D030361	Papillomavirus Infections

Ancestor Terms

ID	Term
D014594	Uterine Neoplasms
D005833	Genital Neoplasms, Female
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided