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

Leiomyoma Clinical Trial

— SOUL  

Official title:

Role of Senescent Cells in Uterine Fibroid Pathogenesis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06135870
• Other study ID #: IRB00359032
• Secondary ID: 1R01HD111243
• Status: Recruiting
• Start date: November 1, 2023
• Est. completion date: December 31, 2027

Study information

• Verified date: December 2023
• Source: Johns Hopkins University
• Contact: James Segars, MD
• Phone: 410-614-2000
• Email: jsegars2[@]jhmi.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Fibroid
• Leiomyoma

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland

Sponsors (3)

Lead Sponsor	Collaborator
Johns Hopkins University	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Validate the concentration senescence-associated secretory profile (SASP) in cell cultures of senescent cells in uterine fibroids	Quantify levels of transcripts and proteins in the fibroid senescence-associated secretory profile (SASP) using ELISA and western blotting techniques	5 years
Secondary	Rate of inhibition of cellular proliferation and ECM deposition by senolytics and senomorphics in fibroids	Examine the in-vitro effects of senotherapeutcis using leiomyoma culture models and in mouse models. Measured by inhibition of proliferation, induction of apoptosis, inhibition ECM deposition, decrease in SnCs (senolytics) and senescence-associated secretory profile SASPs (senomorphics).	5 years