CIN2/3 RecurrenceSUIVICOLNCT01543048
Prognostic Value of Human Papillomavirus (HPV) Detection in Cervical Intra-epithelial Neoplasia (CIN) Recurrence After Conization
An observational study of CIN2/3 Recurrence, run by University Hospital, Bordeaux at 4 sites in France.
Trial summary
CIN2/3 have been increased for many years and mainly concern women aged 25-29 years. They are subsequent to a persistent HPV infection and are classically treated by conization. Recurrences occur in 7 to 18 % of cases, mainly after CIN3 management during the first 2 years of follow-up. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- CIN2/3 Recurrence
- What is being tested?
- Study Follow-Up
- How many people
- 106 participants
- Where
- 4 sitesFrance
- Study dates
- 6 Mar 2012to 1 Aug 2016
- Phase
- Observational
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women with CIN3 treated by conization
Who may be able to join
- Women over 18 years
- CIN 2 or 3 diagnosis at inclusion confirmed for a CIN3 diagnosis by conization.
- HPV detected by Hybrid Capture 2 or RLA genotyping.
- Informed and signed consent by the patient and the investigator
- Coverage by French social security
Who cannot join
- Pregnancy at the time of inclusion.
- Previous history conization.
- Atypical endometrial or glandular cells or evidence of carcinoma on conization.
- Previous vaccination with a prophylactic HPV vaccine.
- Active viral infections including HIV.
- Acquired or congenital immunodeficiency.
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- Long term treatment by corticosteroids or immunosuppressive drugs.
- Persons under protection of law.
- Patients unable to meet the requirements of the protocol.
- Any condition that, according to the investigator, would prevent participation in the study or interfere with the objectives of the study (refusal of supervision at the University Hospital, expected change of address within 3 years, etc)
Trial locations and contacts
4 sites in 1 country.
France4 sites
CHU de Bordeaux
Bordeaux
CHU de Limoges, Hôpital Mère Enfant
Limoges
CHU de Toulouse, Hôpital Paule de Viguier
Toulouse
CHU de Toulouse, Hôpital Rangueil
Toulouse
About this study
Official title: Prognostic Value of Human Papillomavirus (HPV) Detection in Cervical Intra-epithelial Neoplasia (CIN) Recurrence After Conization: Prospective Study With Virological Follow-up on 24 Months (SUIVICOL)
CIN2/3 have been increased for many years and mainly concern women aged 25-29 years. They are subsequent to a persistent HPV infection and are classically treated by conization. Recurrences occur in 7 to 18 % of cases, mainly after CIN3 management during the first 2 years of follow-up. Follow-up is crucial to detect and treat recurrence and to select high risk women who might develop cervical cancer. Colposcopy and cytology have been recommended since 1989 by French ANAES, but these methods have poor sensitivity and specificity. However, DNA HPV testing is more sensitive and has demonstrated a very high negative predictive value, while specificity and positive predictive value remain average. Other HPV markers like genotyping, viral load and integration begin to be used in screening but have not been investigated in CIN2/3 follow-up to assess the values of various HPV markers which predict CIN2/3 recurrence after conization. The primary objective is to describe HPV expression (genotyping, viral load, mRNA E6 and E7) at the time of conization and during the follow-up period (6, 12, 24 months) and to assess the prognostic value of HPV 16 expression (viral load, mRNA E6 and E7) to determine the risk of CIN2/3 recurrence after conization, compared to the other clinical and virological risk factors.
Read the detailed description
Women with CIN3 treated by conization will be consecutively included in this study during 12 months. They will be recruited in the 3 main University Hospitals of South West France (Bordeaux, Toulouse, Limoges) and followed-up for 24 months. Colposcopy (+/- biopsies), cytology, and virology tests will be performed at the time of conization and during the follow-up period (6, 12, 24 months). HPV expression will be assessed by centralized validated marketed tests (Hybrid Capture 2, RLA genotyping, PreTect® HPV-Proofer) and by a real time PCR measuring E2, E6 and E7 viral load of HPV 1.
- Conditions
- CIN2/3 Recurrence
- Being tested
- Study Follow-Up
- Keywords
- Human Papilloma Virus (HPV), Virological tests, CIN3, Cervical cancer, Conization, within women treated by conization for a CIN3
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study Follow-UpOther
Colposcopy (+/- biopsies), cytology, and virology tests will be performed at the time of conization and during the follow-up period (6, 12, 24 months). HPV expression will be assessed by centralized validated marketed tests (Hybrid Capture 2, RLA genotyping, PreTect® HPV-Proofer) and by a real time PCR measuring E2, E6 and E7 viral load of HPV 1.
| Study group | Role | What they receive |
|---|---|---|
| Women with CIN3 treated by conization | Not described Receives: Other: Study Follow-Up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of CIN2/3 diagnosed on colposcopy-directed biopsy
Biopsies will be carried out in cases of abnormal findings by colposcopy, cytological anomalies (ASC-US, ASC-H, LSIL, HSIL, cancer), and/or colpo-cytological discordance. The prognostic impact of HPV16 compared to the other HR-HPV on the recurrence of CIN2/3 will be assessed
Measured: For each patient, 24 month after inclusion
Secondary outcomes (1)
Evaluation of CIN2/3 diagnosis tests
Sensitivity, specificity, positive and negative predictive values of the following tests in the diagnosis of CIN2/3 after conization:
- Cytology (at the ASC-US threshold)
- Colposcopy (at the grade 2 abnormal transformation threshold)
- Hybrid Capture 2 (positivity threshold: 2 pg/ml)
- RLA genotyping (presence or not of HPV 16 and/or other HR-HPV)
- PreTect® HPV-Proofer (presence or not of mRNA E6 and E7 of HPV 16, 18, 31, 33, 45)
Measured: For each patient, 24 month after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2012 (estimated)
- Study start6 Mar 2012
- Primary completion1 Aug 2016
- Study completion1 Aug 2016
Why it stopped: Lack of recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CIN2/3 RecurrenceStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Geneviève CHÊNE, MD-PhD, Study chair, USMR - University Hospital Bordeaux, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01543048
- Sponsor's protocol ID
- CHUBX 2010/18
- Acronym
- SUIVICOL
- Status last verified
- Aug 2017
- First submitted
- 27 Feb 2012
- Last updated
- 24 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of Human Papillomavirus (HPV) Detection in Cervical Intra-epithelial Neoplasia (CIN) Recurrence After Conization: Prospective Study With Virological Follow-up on 24 Months (SUIVICOL)
- ClinicalTrials.gov ID
- NCT01543048
- Acronym / sponsor ID
- SUIVICOL / CHUBX 2010/18
- Conditions
- CIN2/3 Recurrence
- Keywords
- Human Papilloma Virus (HPV), Virological tests, CIN3, Cervical cancer, Conization, within women treated by conization for a CIN3
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Lack of recruitment
- Enrolment
- 106 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 6 Mar 2012 (actual)
- Primary completion
- 1 Aug 2016 (actual)
- Study completion
- 1 Aug 2016 (actual)
- First posted
- 2 Mar 2012 (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.
CIN2/3 have been increased for many years and mainly concern women aged 25-29 years. They are subsequent to a persistent HPV infection and are classically treated by conization. Recurrences occur in 7 to 18 % of cases, mainly after CIN3 management during the first 2 years of follow-up. Follow-up is crucial to detect and treat recurrence and to select high risk women who might develop cervical cancer. Colposcopy and cytology have been recommended since 1989 by French ANAES, but these methods have poor sensitivity and specificity. However, DNA HPV testing is more sensitive and has demonstrated a very high negative predictive value, while specificity and positive predictive value remain average. Other HPV markers like genotyping, viral load and integration begin to be used in screening but have not been investigated in CIN2/3 follow-up to assess the values of various HPV markers which predict CIN2/3 recurrence after conization. The primary objective is to describe HPV expression (genotyping, viral load, mRNA E6 and E7) at the time of conization and during the follow-up period (6, 12, 24 months) and to assess the prognostic value of HPV 16 expression (viral load, mRNA E6 and E7) to determine the risk of CIN2/3 recurrence after conization, compared to the other clinical and virological risk factors.
Detailed description
Women with CIN3 treated by conization will be consecutively included in this study during 12 months. They will be recruited in the 3 main University Hospitals of South West France (Bordeaux, Toulouse, Limoges) and followed-up for 24 months. Colposcopy (+/- biopsies), cytology, and virology tests will be performed at the time of conization and during the follow-up period (6, 12, 24 months). HPV expression will be assessed by centralized validated marketed tests (Hybrid Capture 2, RLA genotyping, PreTect® HPV-Proofer) and by a real time PCR measuring E2, E6 and E7 viral load of HPV 1.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women with CIN3 treated by conization | – | Other: Study Follow-Up |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women with CIN3 treated by conization
Key inclusion criteria (5 listed)
- Women over 18 years
- CIN 2 or 3 diagnosis at inclusion confirmed for a CIN3 diagnosis by conization.
- HPV detected by Hybrid Capture 2 or RLA genotyping.
- Informed and signed consent by the patient and the investigator
- Coverage by French social security
Key exclusion criteria (10 listed)
- Pregnancy at the time of inclusion.
- Previous history conization.
- Atypical endometrial or glandular cells or evidence of carcinoma on conization.
- Previous vaccination with a prophylactic HPV vaccine.
- Active viral infections including HIV.
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 |
|---|---|---|
| Study Follow-UpColposcopy (+/- biopsies), cytology, and virology tests will be performed at the time of conization and during the follow-up period (6, 12, 24 months). HPV expression will be assessed by centralized validated marketed tests (Hybrid Capture 2, RLA genotyping, PreTect® HPV-Proofer) and by a real time PCR measuring E2, E6 and E7 viral load of HPV 1. | Other | Women with CIN3 treated by conization |
Primary outcome
Recurrence of CIN2/3 diagnosed on colposcopy-directed biopsy
Time frame: For each patient, 24 month after inclusion
Biopsies will be carried out in cases of abnormal findings by colposcopy, cytological anomalies (ASC-US, ASC-H, LSIL, HSIL, cancer), and/or colpo-cytological discordance. The prognostic impact of HPV16 compared to the other HR-HPV on the recurrence of CIN2/3 will be assessed
1 secondary outcome
Evaluation of CIN2/3 diagnosis tests
Time frame: For each patient, 24 month after inclusion
Results and safety
The study was stopped early (reason given: Lack of recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2017.
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.
Geneviève CHÊNE, MD-PhD study chair
USMR - University Hospital Bordeaux, France
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of CIN2/3 Recurrence, run by University Hospital, Bordeaux at 4 sites 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 5 inclusion and 10 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: stopped early, as of the sponsor's last update on 24 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 was stopped early (reason given: Lack of recruitment). Results are not available in the source record.
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?
Recurrence of CIN2/3 diagnosed on colposcopy-directed biopsy (time frame: For each patient, 24 month after inclusion). 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 24 Aug 2017.