Actively Recruiting
Conservative Management of HSIL in Patients With Future Pregnancy Aspiration
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
356 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Conservative Management of HSIL in Patients With Future Pregnancy Aspiration
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women of reproductive age planning to become pregnant in the future
- Acceptance of conservative management instead of immediate surgery
- Commitment to attend all scheduled follow-up visits
- Colposcopy showing transformation zone type 1 or 2 with fully visible lesion having grade 2 changes
- Lesion involves less than 50% of the cervical surface with no endocervical involvement
You will not qualify if you...
- Pregnancy at the first visit or during follow-up
- Immunosuppression due to medication or HIV infection
- Suspicion or diagnosis of atypical glandular cells, in situ adenocarcinoma, or cervical cancer
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08041
Actively Recruiting
Research Team
N
Natalia Teixeira, MD, Ph.D.
CONTACT
N
Nerea Nerea, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here