Clinical course of untreated cervical intraepithelial neoplasia grade 2 under active surveillance: systematic review and meta-analysis.
Karoliina Tainio, Antonios Athanasiou, Kari A O Tikkinen...
https://pubmed.ncbi.nlm.nih.gov/29487049/Actively Recruiting
Led by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Updated on 2021-03-05
200
Participants Needed
1
Research Sites
104 weeks
Total Duration
This research aims to analyze spontaneous regression rates of high-grade squamous intraepithelial lesions HSIL, including CIN2 and CIN3, in women of reproductive age. The study focuses on whether conservative management without immediate surgery is safe for women who want to have children in the future, regardless of age. It addresses the uncertainty about managing HSIL in women older than 30, as most evidence supports conservative care mainly in younger women under 30. Women diagnosed with HSIL who choose conservative management will be followed regularly with colposcopy and cytology every 4 months. Biopsies are done when needed based on colposcopic changes. HPV testing will be performed every 8 to 12 months. If HSIL persists after 24 months or worsens, or if the patient no longer meets conservative management criteria, cervical conization surgery will be recommended. Participants will be grouped based on lesion regression or whether they undergo conization. Participants will attend follow-up visits every 4 months for at least 2 years, including colposcopy and cytology assessments, with biopsies as clinically indicated. Researchers will monitor lesion changes, HPV status, and cytology results to evaluate spontaneous regression, persistence, or progression of HSIL. Data on demographics, smoking, sexual history, and HPV vaccination will be collected to identify factors linked to lesion regression. The study aims to safely reduce surgical interventions and support effective surveillance strategies in women wishing to preserve fertility.
CONDITIONS
Conservative Management of HSIL in Patients With Future Pregnancy Aspiration
N
Natalia Teixeira, MD, Ph.D.
N
Nerea Nerea, MD
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Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Lead Sponsor
You may qualify if you...
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Minimum of 2 years
Participants who choose conservative management will be followed with regular evaluations including colposcopy and cytology to monitor HSIL without immediate surgery.
Visits every 4 months including colposcopy and cytology; HPV testing every 8 to 12 months
Duration - As needed during follow-up
Participants who experience progression or persistence of HSIL after 24 months, or no longer meet surveillance criteria, will undergo cervical conization.
1 or more visits depending on clinical need
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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Lead Sponsor