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Completed

NCT Number: NCT02864121

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

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.

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Key information

Conditions

Abnormal Cytology

Age range

25 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Chu de Reims

Reims, 51092, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

all patients included in IDAHO study

Other

Primary outcomes

  1. presence of high-risk papillomavirus in the analysis of cervical smear

    Time frame: during 36 months after inclusion

  2. integration of genome of high-risk papillomavirus detected in cervical smear according molecular combing

    Time frame: during 36 months after inclusion

  3. presence and severity of cervical lesion according to results of cervical smear, colonoscopy and histological analysis

    Time frame: during 36 months after inclusion

Sponsors and collaborators

Lead sponsor

CHU de Reims

Other

Registry information

Official study title

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

Acronym: IDAHO

Important dates

Study start
2015
Primary completion
2018
Study completion
2019
First posted
Aug 11, 2016
Registry last updated
Jun 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.