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Recruiting NCT04057924

NCT04057924 Therapeutic Abstention and Surveillance of Intra-epithelial Histological Lesions of High Grade Cervical CIN2 (Cervical Intraepithelial Neoplasia Grade 2). SUIVICIN

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Clinical Trial Summary
NCT ID NCT04057924
Status Recruiting
Phase
Sponsor University Hospital, Bordeaux
Condition HPV Infection
Study Type OBSERVATIONAL
Enrollment 200 participants
Start Date 2019-08-23
Primary Completion 2029-09-01

Eligibility & Interventions

Sex Female only
Min Age 18 Years
Max Age N/A
Study Type OBSERVATIONAL
Interventions
abstention from CIN2 treatment and surveillance for at least 2 years

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.

This trial targets 200 participants in total. It began in 2019-08-23 with a primary completion date of 2029-09-01.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief Summary

This study proposes to describe and evaluate the rate of spontaneous regression of CIN2 at 2 year of follow up in women between 18 and 39 year old. This follow-up is proposed as an alternative to the treatment of reference (conization) with a possible extension to 4 years

Eligibility Criteria

Inclusion Criteria: * CIN2 confirmed by biopsy, age between 18 and 39 years, * satisfactory colposcopy identifying the junction and the lesion, * affiliated person or beneficiary of a social security scheme, * having given their oral agreement and authorization to the processing of their data. Exclusion Criteria: * Pregnancy in progress, * history of conization, * atypical or atypical glandular cells or cancer incidentally discovered during smear, * prophylactic vaccination against HPV, * active systemic infection requiring treatment, history of HIV infection, congenital or acquired immunodepression, * long-term treatment with corticosteroids or immunosuppressants, placement under safeguard of justice, * non-compliance with protocol requirements, in particular a supposed lack of compliance with long-term follow-up

Contact & Investigator

Central Contact

Jean-Luc Brun, MD, PhD

✉ jean-luc.brun@chu-bordeaux.fr

📞 335 56 79 59 85

Frequently Asked Questions

Who can join the NCT04057924 clinical trial?

This trial is open to female participants only, aged 18 Years or older, studying HPV Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT04057924 currently recruiting?

Yes, NCT04057924 is actively recruiting participants. Contact the research team at jean-luc.brun@chu-bordeaux.fr for enrollment information.

Where is the NCT04057924 trial being conducted?

This trial is being conducted at Bordeaux, France.

Who is sponsoring the NCT04057924 clinical trial?

NCT04057924 is sponsored by University Hospital, Bordeaux. The trial plans to enroll 200 participants.

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