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CompletedNCT02864121IDAHOUpdated Jun 16, 2020

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

An interventional study of all patients included in IDAHO study in Abnormal Cytology, sponsored by CHU de Reims. Completed at 1 site in France. Open to female participants aged 25 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-06-16.

Sponsored by CHU de Reims · Not applicable, Interventional, and Screening

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Dec 2015, registered May 2016).
Phase
Not applicable
Study type
Interventional
Enrollment
407
Allocation
Not applicable
Ages
25 Years to 65 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Abnormal Cytology

Keywords

  • High-risk human papillomavirus
  • Integration of HR-HPV DNA
  • biomarker of severity
  • biomarker of evolution
03

In context

Lead sponsor

CHU de Reims is the lead sponsor of 275 studies on the registry; 49 are open to participants now.

Browse CHU de Reims studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
407 participants (actual)

Study arms

  • Experimental
    arm 1

    all patients included in IDAHO study

    Other: all patients included in IDAHO study

Interventions

  • Otherall patients included in IDAHO study
06

What researchers measure

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

07

Study locations

1 site
  • Chu de Reims
    Reims, 51092, France
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Dec 2015 to primary completion in Dec 2018, 36 months.

How these figures are worked out, and which studies are left out of them.

Registered
May 11, 2016
First posted
Aug 11, 2016
StartActual
Dec 2015
Primary completionActual
Dec 17, 2018
CompletionActual
Dec 17, 2019
Last update
Jun 16, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 16, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02864121
Lead sponsor
CHU de Reims
Responsible party
Sponsor
First posted
Aug 11, 2016
Start date
Dec 2015
Primary completion
Dec 17, 2018
Completion
Dec 17, 2019
Last update
Jun 16, 2020

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.

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