Oncogenous HPV DNA Integration (Intégration De l'ADN Des... | NCT02864121

Studies
Oncogenous HPV DNA Integration (Intégration De l'ADN Des HPV Oncogènes)

NCT02864121

Sponsor

CHU de Reims

Status

Completed

Last Update Posted

Jun 16, 2020Actual

Enrollment

407Actual

Phase

Not Applicable

Conditions

Abnormal Cytology

Interventions

all patients included in IDAHO study

Countries

France

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

Jun 2020

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

Dec 2015Actual

Primary Completion Date

Dec 17, 2018Actual

Completion Date

Dec 17, 2019Actual

First Submitted Date

May 11, 2016

First Submission Date that Met QC Criteria

Aug 10, 2016

First Posted Date

Aug 11, 2016Estimated

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

Jun 11, 2020

Last Update Posted Date

Jun 16, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

High-risk human papillomavirus (HR-HPV) are involved in cervical cancer development. Integration of HR-HPV DNA in cellular genomes is considered as a major event in the cervical cancer development. The aim of this study is to validate the integration of the HPV-HR as an appropriate biomarker of the severity of precancerous lesions and progression of cervical lesions towards cervical cancer. HR-HPV integration status will be analyzed by Molecular Combing technology, which allows direct and high-resolution visualization of the integration of high-risk HPV genomes.

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

407Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
arm 1	Experimental	all patients included in IDAHO study	Other: all patients included in IDAHO study

Interventions

Name	Type	Description	Arm Group Labels	Other Names
all patients included in IDAHO study	Other		arm 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
presence of high-risk papillomavirus in the analysis of cervical smear		during 36 months after inclusion
integration of genome of high-risk papillomavirus detected in cervical smear according molecular combing		during 36 months after inclusion
presence and severity of cervical lesion according to results of cervical smear, colonoscopy and histological analysis		during 36 months after inclusion

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

women aged from 25 to 65 years
consulting in a gynecological-obstetrical service of one of the investigator center for a colposcopy reflex after an abnormal cytology dating of less than 6 months and more than 1 month
signature of the informed consent
affiliated to Social Security

Exclusion Criteria:

women vaccinated against HPV
women who received a treatment for a cervical pathology followed by a normal
women with a known positive HIV test
women suffering from a chronic pathology that generate immunosuppression
Women currently treated with immunosuppressors
Women treated with corticoids currently or dating of less than 6 months
protected by law
pregnant

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided