Prognostic Value of Human Papillomavirus (HPV) Detection in Cervical Intra-epithelial Neoplasia (CIN) Recurrence After Conization

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Total Enrollment

106 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-03-06

Study Completion Date

2016-08-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Retrospective Cohort Study of the Effectiveness of the Prophylactic Vaccine Against the Human Papilloma Virus in the Prevention of Recurrence in Women Who Have Received an Excisional Therapy by HSIL / CIN.

NCT04171505

Cervix, Dysplasia HPV Infection HPV Vaccine +1 more

UNKNOWN

Therapeutic Abstention and Surveillance of Intra-epithelial Histological Lesions of High Grade Cervical CIN2 (Cervical Intraepithelial Neoplasia Grade 2). SUIVICIN

NCT04057924

HPV Infection Cervical Cancer

RECRUITING

A Multicenter Cohort Study of HPV Viral Load in Predicting the Postoperative Recurrence of HSIL

NCT05282745

HPV Infection HSIL, High-Grade Squamous Intraepithelial Lesions Viral Load

RECRUITING

Agreement Between Oral and Cervical Human Papillomavirus Infection in a French Cohort

NCT02774538

Human Papillomavirus-Related Cervical Carcinoma

COMPLETED NA

Infectious Risk of Vaginal Ultrasound Examination: Evaluation and Modeling From Human Papillomavirus (HPV)

NCT02659072

GYNAECOLOGICAL INFECTION

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

CIN2/3 Recurrence

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Women with CIN3 treated by conization

Study Follow-Up

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Study Follow-Up

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No