Clinical trial · Observational
Role of Senescent Cells in Uterine Fibroid Pathogenesis (SOUL Study)
Role of Senescent Cells in Uterine Fibroid Pathogenesis
NCT06135870CI-TRIAL-00098799SOULrecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The investigators are evaluating the role of senescent cells in uterine fibroids.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Women with fibroids undergoing elective hysterectomy or myomectomy
- description
- Women between the age of 18-55 with fibroids undergoing elective hysterectomy or myomectomy
Primary outcomes (1)
- measure
- Develop an atlas to comprehensively quantify the rate of senescent cell (SnC) types in fibroid and myometrium tissue samples
- timeFrame
- 5 years
- description
- 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 (2)
- measure
- Validate the concentration senescence-associated secretory profile (SASP) in cell cultures of senescent cells in uterine fibroids
- timeFrame
- 5 years
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 55 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.