Cervical Intraepithelial Neoplasia Clinical Trial
Official title:
Conservative Management of Patients Diagnosed With High-grade Squamous Intraepithelial Lesions (H-SIL) Who Have Pregnancy Intentions: a Prospective Observational Study
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.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | December 31, 2027 |
Est. primary completion date | December 31, 2025 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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) |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital de la Santa Creu i Sant Pau | Barcelona |
Lead Sponsor | Collaborator |
---|---|
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau |
Spain,
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McCredie MR, Sharples KJ, Paul C, Baranyai J, Medley G, Jones RW, Skegg DC. Natural history of cervical neoplasia and risk of invasive cancer in women with cervical intraepithelial neoplasia 3: a retrospective cohort study. Lancet Oncol. 2008 May;9(5):425-34. doi: 10.1016/S1470-2045(08)70103-7. Epub 2008 Apr 11. — View Citation
Tainio K, Athanasiou A, Tikkinen KAO, Aaltonen R, Cárdenas J, Hernándes, Glazer-Livson S, Jakobsson M, Joronen K, Kiviharju M, Louvanto K, Oksjoki S, Tähtinen R, Virtanen S, Nieminen P, Kyrgiou M, Kalliala I. Clinical course of untreated cervical intraepithelial neoplasia grade 2 under active surveillance: systematic review and meta-analysis. BMJ. 2018 Feb 27;360:k499. doi: 10.1136/bmj.k499. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | HSIL regression | Abscence of colposcopic lesion or regression of colposcopic lesion | 2 years | |
Primary | Cytology | normal, LSIL or ASCUS | 2 years | |
Primary | Biopsy | normal, LSIL or ASCUS | 2 years | |
Primary | VPH | negative HPV for the HPV type initially detected | 2 years |
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