Development of a blood test for uterine sarcoma - diagnosis

Development of a blOOdtest for uteRine Sarcoma - Diagnosis (DOORS-D)

Registry ID
ISRCTN14800787
Source registry
ISRCTN
Status
Recruiting
Study type
OBSERVATIONAL
Sponsor
University of Leicester
Enrollment
50
Start date
2025-07-01
Completion date
2028-03-01
Last update
2026-08-17

Conditions

Summary

Uterine sarcomas and uterine fibroids

Detailed description

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 recruit patients who are due to undergo surgery for a large fibroid or suspected of having a uterine sarcoma. We will collect information from investigations that are performed before surgery, including scan images (ultrasound/magnetic resonance imaging (MRI)/computer tomography (CT)/positron emission tomography (PET) MRI/CT/PET scans), blood test results, and biopsies from the endometrium (womb lining). A sample of blood will be taken before the planned surgery for ctDNA analysis and compared with the outcome from surgery. A number of participants will also be invited to take part in an interview to discuss their experiences in the study and their views on the potential for a blood test to diagnose uterine sarcomas.

Interventions

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

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

Locations

Related clinical trials

View on source registry