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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06135870
Other study ID # IRB00359032
Secondary ID 1R01HD111243
Status Recruiting
Phase
First received
Last updated
Start date November 1, 2023
Est. completion date December 31, 2027

Study information

Verified date December 2023
Source Johns Hopkins University
Contact James Segars, MD
Phone 410-614-2000
Email jsegars2@jhmi.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The investigators are evaluating the role of senescent cells in uterine fibroids.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date December 31, 2027
Est. primary completion date December 31, 2027
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 55 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Johns Hopkins Hospital Baltimore Maryland

Sponsors (3)

Lead Sponsor Collaborator
Johns Hopkins University Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 5 years
Secondary 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 5 years
Secondary 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). 5 years
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