Actively Recruiting

FEMALE
ID04783805

Conservative Management of Patients Diagnosed With High-grade Squamous Intraepithelial Lesions (HSIL) Who Have Pregnancy Intentions: a Prospective Observational Study

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

On this page

AI-Summary

What this Trial Is About

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

Brief Title

Conservative Management of HSIL in Patients With Future Pregnancy Aspiration

Who Can Participate

FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Women of reproductive age with aspirations of future pregnancies
  • Acceptance of conservative management instead of immediate surgery
  • Commitment to attend scheduled follow-up visits
  • Colposcopy showing transformation zone type 1 or 2 with fully visible grade 2 lesion
  • Lesion involves less than 50% of the cervical surface without endocervical involvement
Not Eligible

You will not qualify if you...

  • Pregnancy at first visit or during follow-up
  • Immunosuppression due to medication or HIV
  • Suspected or diagnosed atypical glandular cells, in situ adenocarcinoma, or cervical cancer

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surveillance

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

Conization

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

Trial Site Locations

Total: 1 location

1

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain, 08041

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Research Team

N

Natalia Teixeira, MD, Ph.D.

N

Nerea Nerea, MD

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

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Published Research Related To This Trial

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

Outcome of expectant management of cervical intraepithelial neoplasia grade 2 in women followed for 12 months.

Michelle G Discacciati, Carlos André S de Souza, Maria Gabriela d'Otavianno...

https://pubmed.ncbi.nlm.nih.gov/21193261

Natural history of cervical neoplasia and risk of invasive cancer in women with cervical intraepithelial neoplasia 3: a retrospective cohort study.

Margaret R E McCredie, Katrina J Sharples, Charlotte Paul...

https://pubmed.ncbi.nlm.nih.gov/18407790

Obstetric outcomes after conservative treatment for intraepithelial or early invasive cervical lesions: systematic review and meta-analysis.

M Kyrgiou, G Koliopoulos, P Martin-Hirsch...

https://pubmed.ncbi.nlm.nih.gov/16473126

Adverse obstetric outcomes after local treatment for cervical preinvasive and early invasive disease according to cone depth: systematic review and meta-analysis.

Maria Kyrgiou, Antonios Athanasiou, Maria Paraskevaidi...

https://pubmed.ncbi.nlm.nih.gov/27469988

Obstetric outcomes after conservative treatment for cervical intraepithelial lesions and early invasive disease.

Maria Kyrgiou, Antonios Athanasiou, Ilkka E J Kalliala...

https://pubmed.ncbi.nlm.nih.gov/29095502