Abnormal CytologyIDAHONCT02864121
Oncogenous HPV DNA Integration (Intégration De l'ADN Des HPV Oncogènes)
A study testing all patients included in IDAHO study in people with Abnormal Cytology, run by CHU de Reims at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 65 years, women only
- Conditions the study is for
- Abnormal Cytology
- What is being tested?
- all patients included in IDAHO study
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 407 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2015to 17 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association Between High-risk HPV Genome Integration Detected by Molecular Combing and Cervical Lesions Severity and/or Evolution
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.
- Conditions
- Abnormal Cytology
- Being tested
- all patients included in IDAHO study
- Keywords
- High-risk human papillomavirus, Integration of HR-HPV DNA, biomarker of severity, biomarker of evolution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
all patients included in IDAHO studyOther
| Study group | Role | What they receive |
|---|---|---|
| arm 1 | Experimental | all patients included in IDAHO study Receives: Other: all patients included in IDAHO study |
What is being measured
The primary outcome is the main question the study is designed to answer.
presence of high-risk papillomavirus in the analysis of cervical smear
Measured: during 36 months after inclusion
integration of genome of high-risk papillomavirus detected in cervical smear according molecular combing
Measured: during 36 months after inclusion
presence and severity of cervical lesion according to results of cervical smear, colonoscopy and histological analysis
Measured: during 36 months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2016 (estimated)
- Study startDec 2015
- Primary completion17 Dec 2018
- Study completion17 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abnormal CytologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 407 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02864121
- Sponsor's protocol ID
- PI15088
- Acronym
- IDAHO
- Status last verified
- Jun 2020
- First submitted
- 11 May 2016
- Last updated
- 16 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between High-risk HPV Genome Integration Detected by Molecular Combing and Cervical Lesions Severity and/or Evolution
- ClinicalTrials.gov ID
- NCT02864121
- Acronym / sponsor ID
- IDAHO / PI15088
- Conditions
- Abnormal Cytology
- Keywords
- High-risk human papillomavirus, Integration of HR-HPV DNA, biomarker of severity, biomarker of evolution
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 407 participants (actual)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- Dec 2015 (actual)
- Primary completion
- 17 Dec 2018 (actual)
- Study completion
- 17 Dec 2019 (actual)
- First posted
- 11 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| arm 1 | Experimental | Other: all patients included in IDAHO studyall patients included in IDAHO study |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| all patients included in IDAHO study | Other | arm 1 |
Primary outcome
presence of high-risk papillomavirus in the analysis of cervical smear
Time frame: during 36 months after inclusion
integration of genome of high-risk papillomavirus detected in cervical smear according molecular combing
Time frame: during 36 months after inclusion
presence and severity of cervical lesion according to results of cervical smear, colonoscopy and histological analysis
Time frame: during 36 months after inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2020.
Related trials for Abnormal Cytology
RecruitingPhase 2
Phase II Study of Dysplasix™ Intravaginal Suppositories in Patients Patients With High-Risk HPV and Mild Cervical Cytologic Abnormalities
High-risk HPV (Any Strain), LSIL, Low Grade Squamous Intraepithelial Lesion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing all patients included in IDAHO study in people with Abnormal Cytology, run by CHU de Reims at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
presence of high-risk papillomavirus in the analysis of cervical smear (time frame: during 36 months after inclusion). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2020.