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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03959410
Recruitment Status : Active, not recruiting
First Posted : May 22, 2019
Last Update Posted : May 22, 2019
Sponsor:
Information provided by (Responsible Party):
Prof. Pasquale De Franciscis, University of Campania "Luigi Vanvitelli"

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

Condition or disease Intervention/treatment
Cervix Cancer Diagnostic Test: Cervical biopsy

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : January 4, 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Group/Cohort Intervention/treatment
HPV-positive patients
Patients who are positive for HPV DNA test
Diagnostic Test: Cervical biopsy
in office Cervical biopsy




Primary Outcome Measures :
  1. Evaluation of Cervical microbiome [ Time Frame: 12 months ]

Biospecimen Retention:   Samples Without DNA
Cervical biopsies


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sampling Method:   Non-Probability Sample
Study Population
Italian fertile women positive for HPV DNA test
Criteria

Inclusion Criteria:

  • Women in fertile age

Exclusion Criteria:

  • severe comorbidities

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03959410


Locations
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Italy
Department of Woman, Child and General and Specialized Surgery, University of Campania "Luigi Vanvitelli"
Napoli, Italy, 80122
Sponsors and Collaborators
University of Campania "Luigi Vanvitelli"

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Responsible Party: Prof. Pasquale De Franciscis, Associate Professor, University of Campania "Luigi Vanvitelli"
ClinicalTrials.gov Identifier: NCT03959410     History of Changes
Other Study ID Numbers: N.594
First Posted: May 22, 2019    Key Record Dates
Last Update Posted: May 22, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Prof. Pasquale De Franciscis, University of Campania "Luigi Vanvitelli":
hpv
cervical cancer
microbiome

Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female