Role of Senescent Cells in Uterine Fibroid Pathogenesis (SOUL Study)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Fibroid, Leiomyoma. Basic parameters: 18 years — 55 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Role of Senescent Cells in Uterine Fibroid Pathogenesis
Overview
The investigators are evaluating the role of senescent cells in uterine fibroids.
Detailed 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.
Primary outcome measures
- Develop an atlas to comprehensively quantify the rate of senescent cell (SnC) types in fibroid and myometrium tissue samples [Time frame: 5 years]
Secondary outcome measures (2)
- Validate the concentration senescence-associated secretory profile (SASP) in cell cultures of senescent cells in uterine fibroids [Time frame: 5 years]
- Rate of inhibition of cellular proliferation and ECM deposition by senolytics and senomorphics in fibroids [Time frame: 5 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Johns Hopkins Hospital — Baltimore
Identifiers
NCT: NCT06135870 · IRB00359032 · 1R01HD111243