Examining the Prognostic Value of Conization and HPV Status in Early Cervical Cancer
The Prognostic Value of Conization and Negative HPV Typing After Conization Prior to Surgical Intervention in Adenocarcinoma in Situ and Early Stage Cervical Cancer
This study is trying to see if having a negative high-risk HPV test after a certain surgery can help women with early-stage cervical cancer understand their chances of recovery and if it leads to better treatment outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | Female |
| Sponsor | Rambam Health Care Campus Academic / other |
| Locations | 1 site (Haifa) |
| Trial ID | NCT06196190 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the prognostic significance of negative high-risk HPV (HR-HPV) status after conization in women diagnosed with cervical cancer, specifically those with squamous cell carcinoma, adeno carcinoma, adeno-squamous carcinoma, or adenocarcinoma in situ (AIS). The study will also investigate whether conization in women with early-stage cervical tumors (up to Stage I B2) correlates with improved prognosis. By analyzing the relationship between HPV status and residual tumor presence in final pathology, the study seeks to provide insights into treatment outcomes and recurrence rates. The findings could help refine treatment strategies for early-stage cervical cancer patients.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 18-85 with cervical cancer stage I B2 or AIS and known HPV types before and after conization.
Not a fit: Patients who are pregnant, under 18 years old, or those who refuse to participate or have incomplete data may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved prognostic assessments and treatment strategies for women with early-stage cervical cancer.
How similar studies have performed: Previous studies have indicated that conization may correlate with better prognosis in early-stage cervical cancer, suggesting that this approach has shown promise in similar contexts.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Age Range: 18-85 years old Cervical cancer stage I B 2(Tumor up to 4 cm FIGO 2018) AIS HPV types before and after conization Exclusion Criteria: Pregnant women under 18 years old. Women who refused to continue to be in study. Women that data about HPV types , final pathology or complication are missing.
Where this trial is running
Haifa
- Rambam Health Care Center — Haifa, Israel (Recruiting)
Study contacts
- Principal investigator: Yoav Siegler, MD — Rambam Health Care Center
- Study coordinator: Yoav Siegler, MD
- Email: yoav.siegler@gmail.com
- Phone: +972528263054
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.