About this trial
The investigators are evaluating the role of senescent cells in uterine fibroids.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Unwilling to sign the consent form or complete questionnaire.
Pregnancy.
Cancer of the uterus
Trial population
Women between the age of 18-55 years undergoing elective hysterectomy or myomectomy for uterine fibroids
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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
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).
Sponsors and contacts
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Johns Hopkins University
Lead sponsor
National Institutes of Health (NIH)
Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator