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Trial Title:
Role of Senescent Cells in Uterine Fibroid Pathogenesis (SOUL Study)
NCT ID:
NCT06135870
Condition:
Fibroid
Leiomyoma
Conditions: Official terms:
Leiomyoma
Myofibroma
Conditions: Keywords:
Senescent cells
Fibroids
Leiomyomas
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Summary:
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.
Criteria for eligibility:
Study pop:
Women between the age of 18-55 years undergoing elective hysterectomy or myomectomy for
uterine fibroids
Sampling method:
Non-Probability Sample
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
Gender:
Female
Minimum age:
18 Years
Maximum age:
55 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Johns Hopkins Hospital
Address:
City:
Baltimore
Zip:
21287
Country:
United States
Status:
Recruiting
Contact:
Last name:
Rachel Mitchel
Email:
rmiche10@jhmi.edu
Start date:
November 1, 2023
Completion date:
December 31, 2027
Lead sponsor:
Agency:
Johns Hopkins University
Agency class:
Other
Collaborator:
Agency:
National Institutes of Health (NIH)
Agency class:
NIH
Collaborator:
Agency:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Agency class:
NIH
Source:
Johns Hopkins University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06135870
