Actively Recruiting

Age: 18Years - 55Years
FEMALE
ID06135870

Role of Senescent Cells in Uterine Fibroid Pathogenesis

Led by Johns Hopkins University · Updated on 2025-12-11

150

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

J

Johns Hopkins University

Lead Sponsor

N

National Institutes of Health (NIH)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying uterine fibroids, which are common tumors made up of excessive fibrous tissue in the uterus. This research focuses on the role of senescent cells, a small group of aged cells in fibroids, and how they interact with immune cells to promote tissue fibrosis. The goal is to understand these cell communication networks to help develop new treatments for uterine fibroids. Women aged 18 to 55 with fibroids who are scheduled for elective hysterectomy or myomectomy are included in the study. Tissue samples from fibroids and surrounding uterine muscle will be collected and analyzed using advanced computational methods. The study plans to create a detailed atlas quantifying different types of senescent cells over five years. Participants will provide fibroid and myometrium tissue samples during surgical procedures. Researchers will measure the amount and types of senescent cells, validate factors secreted by these cells, and assess how certain drugs affect cell growth and tissue buildup in fibroids. The study lasts up to five years, during which tissue samples and laboratory analyses will be conducted to deepen the understanding of fibroid biology and senescent cell involvement.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 55Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Women aged 18 to 55 years
  • Women with suspected uterine fibroids
  • Women who are or have been sexually active or have had a previous vaginal exam with a speculum
  • Ability to understand, read, and speak English or Spanish and consent to procedures and use of health information
Not Eligible

You will not qualify if you...

  • Unwillingness to sign the consent form or complete questionnaires
  • Current pregnancy
  • Cancer of the uterus

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Up to time of elective surgery

Participants undergo evaluation related to their uterine fibroids and planned elective surgery.

1 to 2 visits depending on surgical scheduling

Surgery and Immediate Post-operative Care

Duration - Day of surgery and immediate recovery period

Participants undergo elective hysterectomy or myomectomy with collection of fibroid and myometrium tissue samples for analysis.

1 surgical visit and immediate post-operative assessment

Long-term Monitoring

Duration - Up to 5 years

Participants are observed for development of senescent cell markers and fibrosis progression through tissue analyses.

Follow-up visits as per routine clinical care; no additional trial visits required

Trial Site Locations

Total: 1 location

1

Johns Hopkins Hospital

Baltimore, Maryland, United States, 21287

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Research Team

J

James Segars, MD

B

Bhuchitra Singh, MD, MPH, MBA

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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