A Study on the Pathogenesis and Determinants of Intravenous Leiomyomatosis

NCT ID: NCT06773819

Last Updated: 2025-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-05-01

Study Completion Date

2027-12-31

Brief Summary

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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

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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.

Conditions

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Intravenous Leiomyomatosis HPV Infection

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Peking Union Medical College Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Bao Liu, MD

Role: CONTACT

010-69152592

Other Identifiers

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IVL001

Identifier Type: -

Identifier Source: org_study_id

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