Conservative Management of HSIL in Patients With Future Pregnancy Aspiration
Recruiting now
Conditions studied: Cervical Intraepithelial Neoplasia, Squamous Intraepithelial Lesions of the Cervix, Uterine Cervical Dysplasia
In brief
Conservative management of high-grade squamous intraepithelial lesions (HSILs) seems safe and justified in young women (\<30 years), but evidence is insufficient on whether it is also advisable for older women. This study will be conducted to analyze spontaneous HSIL regression rates in women of reproductive age and establish whether conservative HSIL management could be safely recommended to women of childbearing potential, irrespective of age. This is a single-center prospective observational study that will include consecutive women of reproductive age, referred to a tertiary hospital due to HSIL between March 2021 and December 2025, who prefer conservative management rather than immediate cervical conization. All patients will be followed-up regularly with colposcopy, cytology, human papillomavirus (HPV) testing and biopsies. In case their lesions progress or HSIL persists after 24 months of follow-up, conization will be indicated. Rates of spontaneous regression or resolution, as well as progression rates, will be assessed. Furthermore, the association between potential predictive factors and HSIL resolution will be analyzed.
Key facts
- Study ID
- NCT04783805
- Run by
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- People needed
- 200
- Starts
- 2021-03-03
- Expected to finish
- 2027-12-31
- Last updated by the study team
- 2021-03-05
Who can join
Age: any. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Reproductive age and aspirations of future pregnancies
- Acceptance of conservative management
- Commitment to attend scheduled follow-up visits
- Colposcopy with transformation zone (ZT) type 1 or 2 (fully visible squamous-columnar union) with lesion with grade 2 changes visible in its entirety. No endocervical involvement
- Colposcopy with grade 2 changes that are not extensive: <50% of the cervical surface
You may not qualify if…
- Pregnancy at first visit or during follow-up.
- Immunosuppression (either iatrogenic or due to human immunodeficiency virus (HIV))
- Suspected or diagnosed Atypical Glandular Cells (ACG), In Situ Adenocarcinoma (AIS) or Cervical Cancer (CC)
Where it is running
- Hospital de la Santa Creu i Sant Pau — Barcelona, Spain (enrolling)
Full record on ClinicalTrials.gov
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