A Study on the Pathogenesis and Determinants of Intravenous Leiomyomatosis

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.

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Key information

Conditions

Intravenous Leiomyomatosis Communicable Diseases DNA Virus Infections Disease Attributes Genital Diseases HPV Infection Infections Papillomavirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Tumor Virus Infections Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

HPV-DNA test result

Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Bao Liu, MD

CONTACT

[email protected]

010-69152592

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2027
First posted: Jan 14, 2025
Registry last updated: Feb 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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