A Study on the Pathogenesis and Determinants of Intravenous Leiomyomatosis

Not yet recruiting

• Conditions: HPV Infection; Intravenous Leiomyomatosis

• Registration Number: NCT06773819
• Lead Sponsor: Peking Union Medical College Hospital

Brief Summary

The goal of this observational study is to learn about the impact of HPV infection in women with intravenous leiomyomatosis(IVL). The main question it aims to answer is:

Does HPV infection promote the development of IVL from uterine leiomyoma? Surgical sections and HPV-DNA test results will be collected in participants diagnosed with IVL or uterine leiomyoma.

Detailed Description

Previous proteomic studies have demonstrated that HPV infection-related proteins are more highly expressed in intravenous leiomyomatosis (IVL) compared to uterine leiomyoma (uML). Consequently, we conducted a case-control study to investigate the association between HPV and the development of IVL. We recruited adult patients diagnosed with either IVL or uML, collected their medical histories, surgical specimens from various sites, and HPV-DNA test results from cervical exfoliated cells, and performed subsequent statistical analyses and mechanistic investigations.

Study Timeline

• Study First Submitted: 2024-12-30
• Study First Submitted QC: 2025-01-12
• Study First Posted: 2025-01-14
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-25
• Last Update Posted: 2025-02-28
• Study Start: 2025-05-01
• Primary Completion: 2025-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

• Adult female patients with suspected IVL or uterine leiomyoma who receive surgery at PUMCH
• Be able to understand and sign the informed consent

Exclusion Criteria

• Patients with other concurrent malignant tumors
• Pregnant or lactating female
• Postoperative pathology do not include IVL or uterine leiomyoma

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
HPV-DNA test result	From date of enrollment until the date of surgery at PUMCH or date of death from any cause, whichever came first, assessed up to 100 months