FibroidSOULNCT06135870
Role of Senescent Cells in Uterine Fibroid Pathogenesis (SOUL Study)
An observational study of Fibroid and Leiomyoma, run by Johns Hopkins University at 1 site in United States.
Trial summary
The investigators are evaluating the role of senescent cells in uterine fibroids. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2023to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- No healthy volunteers
- Adult
Study population: Women between the age of 18-55 years undergoing elective hysterectomy or myomectomy for uterine fibroids
Who may be able to join
- 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.
Who cannot join
- Unwilling to sign the consent form or complete questionnaire.
- Pregnancy.
- Cancer of the uterus
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Rachel Mitchel, rmiche10@jhmi.edu
About this study
Official title: Role of Senescent Cells in Uterine Fibroid Pathogenesis
The investigators are evaluating the role of senescent cells in uterine fibroids.
Read the 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.
- Keywords
- Senescent cells, Fibroids, Leiomyomas
- Medical subject headings
- Leiomyoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Women with fibroids undergoing elective hysterectomy or myomectomy | Women between the age of 18-55 with fibroids undergoing elective hysterectomy or myomectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years
Secondary outcomes (2)
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
Measured: 5 years
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).
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start1 Nov 2023
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibroidStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- James Segars, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06135870
- Sponsor's protocol ID
- IRB00359032
- Other IDs
- 1R01HD111243
- Acronym
- SOUL
- Status last verified
- Dec 2025
- First submitted
- 9 Nov 2023
- Last updated
- 11 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Senescent Cells in Uterine Fibroid Pathogenesis
- ClinicalTrials.gov ID
- NCT06135870
- Acronym / sponsor ID
- SOUL / IRB00359032
- Keywords
- Senescent cells, Fibroids, Leiomyomas
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women with fibroids undergoing elective hysterectomy or myomectomy | – | –Women between the age of 18-55 with fibroids undergoing elective hysterectomy or myomectomy |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women between the age of 18-55 years undergoing elective hysterectomy or myomectomy for uterine fibroids
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Unwilling to sign the consent form or complete questionnaire.
- Pregnancy.
- Cancer of the uterus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Develop an atlas to comprehensively quantify the rate of senescent cell (SnC) types in fibroid and myometrium tissue samples
Time frame: 5 years
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.
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2025.
- Individual participant dataSharing planned: No
Related trials for Fibroid
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Life Study: Lifestyle Intervention in Fibroid Elimination
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Office Hysteroscopy Versus Operating-room Hysteroscopy for Uterine Lesions
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
James Segars, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fibroid and Leiomyoma, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact James Segars, MD (410-614-2000, jsegars2@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Develop an atlas to comprehensively quantify the rate of senescent cell (SnC) types in fibroid and myometrium tissue samples (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2025.