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Role of Senescent Cells in Uterine Fibroid Pathogenesis (SOUL Study)

NCT ID: NCT06135870

Last Updated: 2024-12-24

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

RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-01

Study Completion Date

2027-12-31

Brief Summary

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The investigators are evaluating the role of senescent cells in uterine fibroids.

Detailed Description

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Uterine fibroids are prevalent tumors of uterus characterized by excessive fibrotic tissues. Using new cutting-edge computational methods, the investigators have found that small groups of senescent cells in fibroids work in concert with immune cells to produce soluble factors in fibroid tissues to create a feed-forward loop leading to fibrosis. This project seeks to unravel key cell-cell communication networks involving senescent and immune cells in fibroids to develop new treatments for uterine fibroids.

Conditions

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Fibroid Leiomyoma

Keywords

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Senescent cells Fibroids Leiomyomas

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Women with fibroids undergoing elective hysterectomy or myomectomy

Women between the age of 18-55 with fibroids undergoing elective hysterectomy or myomectomy

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Subjects must be women above the age of ≥18 - ≤55 years.
* Women with suspected uterine fibroids.
* Subject must be or have been sexually active or have had a previous vaginal exam that used a speculum.
* Subject must be able to understand, read and speak English or Spanish and subsequently, be able to understand what she is consenting to in terms of procedures and use/disclosure of protected health information.

Exclusion Criteria

* Unwilling to sign the consent form or complete questionnaire.
* Pregnancy.
* Cancer of the uterus
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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James Segars, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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Johns Hopkins Hospital

Baltimore, Maryland, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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James Segars, MD

Role: CONTACT

Phone: 410-614-2000

Email: [email protected]

Bhuchitra Singh, MD, MPH, MBA

Role: CONTACT

Phone: 410-614-2000

Email: [email protected]

Facility Contacts

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Rachel Mitchel

Role: primary

Other Identifiers

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1R01HD111243

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00359032

Identifier Type: -

Identifier Source: org_study_id