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

Association Between High-risk HPV Genome Integration Detected by Molecular Combing and Cervical Lesions Severity and/or Evolution

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02864121

Acronym

IDAHO

Enrollment

407

Registered

2016-08-11

Start date

2015-12-31

Completion date

2019-12-17

Last updated

2020-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abnormal Cytology

Keywords

High-risk human papillomavirus, Integration of HR-HPV DNA, biomarker of severity, biomarker of evolution

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.

Interventions

OTHERall patients included in IDAHO study

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SCREENING

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

25 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026