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

Johns Hopkins University

Status: Enrolling

Conditions: Leiomyoma; Fibroid

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT06135870

IRB00359032

1R01HD111243 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment: 150 estimated patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

150 participants in 1 patient group

Women with fibroids undergoing elective hysterectomy or myomectomy

Description:

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