Uterine sarcomas and uterine fibroids Urological and Genital Diseases
Conditions
Interventions
Development of a blood test to improve the diagnostic process
This project aims to pilot the use of a ctDNA-based test to help identify patients who have or do not have a uterine sarcoma. We will rec
Sponsors
University of Leicester
Eligibility
Sex/Gender
Female
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Due to undergo surgery (hysterectomy or myomectomy) for a suspected uterine sarcoma or an abnormally appearing fibroid 2. Aged 18-99 years 3. Female 4. Willing and able to consent to participate in the trial
Exclusion criteria
Exclusion criteria: 1. Not undergoing surgery (hysterectomy or myomectomy) for a suspected uterine sarcoma or abnormal appearance fibroid 2. Male 3. Not willing and able to consent to participate in the trial 4. Unable to understand the study requirements despite interpreter support
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Identification of uterine sarcomas by genomic testing of plasma pre-operatively | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Genomic profile of sarcomas and fibroids measured using biopsies taken from hysterectomy or myomectomy specimens 2. Sensitivity/specificity of the ctDNA test to diagnose uterine sarcomas in the pre-operative blood sample 3. Sensitivity/specificity of an expert radiologist versus AI to diagnose uterine sarcomas from pre-operative CT/MRI/PET imaging 4. Psychological impact of ctDNA testing in US diagnosis measured using qualitative interviews at 1-6 months following hysterectomy/myomectomy | — |
Countries
England, United Kingdom
Contacts
Public ContactEsther Moss
Outcome results
None listed