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

NCT06135870 | Recruiting

• 2 other identifiers: IRB003590321R01HD111243
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Fibroid; Leiomyoma

Keywords

Senescent cells; Fibroids; Leiomyomas

Outcome Measures

Primary Outcomes (1)

• Develop an atlas to comprehensively quantify the rate of senescent cell (SnC) types in fibroid and myometrium tissue samples

  Perform scRNASeq on human fibroids and control myometrium tissue and apply transfer learning algorithm for SnC identification and phenotyping to identify cell-cell communication patterns in fibroids versus control myometrial tissue using Domino to validate computationally predicted senescent cell types. The computationally predicted immune phenotypes will be validated with flow cytometry.

  5 years

Secondary Outcomes (2)

• Validate the concentration senescence-associated secretory profile (SASP) in cell cultures of senescent cells in uterine fibroids

  5 years

• Rate of inhibition of cellular proliferation and ECM deposition by senolytics and senomorphics in fibroids

  5 years

Study Arms (1)

Women with fibroids undergoing elective hysterectomy or myomectomy

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

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women between the age of 18-55 years undergoing elective hysterectomy or myomectomy for uterine fibroids

You may qualify if:

• 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.

You may not qualify if:

• Unwilling to sign the consent form or complete questionnaire.
• Pregnancy.
• Cancer of the uterus

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institutes of Health (NIH): collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Fibroid, myometrial samples, and peripheral blood sample.

MeSH Terms

Conditions

Leiomyoma

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Study Officials

• James Segars, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

James Segars, MD

CONTACT

410-614-2000; jsegars2@jhmi.edu

Bhuchitra Singh, MD, MPH, MBA

CONTACT

410-614-2000; bsingh10@jhmi.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2023
• First Posted: November 18, 2023
• Study Start: November 1, 2023
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: December 11, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)