Clinical trial NCT01543048: Prognostic Value of Human Papillomavirus (HPV) Detection in Cervical Intra-epithelial Neoplasia (CIN) Recurrence After Conization
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)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: CIN2/3 Recurrence
Keywords: Human Papilloma Virus (HPV)
Virological tests
CIN3
Cervical cancer
Conization
within women treated by conization for a CIN3
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2012-03-02
Enrollment: 106
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with CIN3 treated by conization

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.
* 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)

Primary outcomes:
measure: Recurrence of CIN2/3 diagnosed on colposcopy-directed biopsy
timeFrame: For each patient, 24 month after inclusion
Secondary outcomes:
measure: Evaluation of CIN2/3 diagnosis tests
timeFrame: For each patient, 24 month after inclusion
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux
city: Limoges
country: France
facility: CHU de Limoges, Hôpital Mère Enfant
city: Toulouse
country: France
facility: CHU de Toulouse, Hôpital Paule de Viguier
city: Toulouse
country: France
facility: CHU de Toulouse, Hôpital Rangueil
Study officials:
affiliation: USMR - University Hospital Bordeaux, France
name: Geneviève CHÊNE, MD-PhD
role: STUDY_CHAIR
References: