Development of a bloodtest for uterine sarcoma monitoring

Development of a blOOdtest for uteRine Sarcoma – Monitoring (DOORS-M)

Registry ID
ISRCTN14174468
Source registry
ISRCTN
Status
Recruiting
Study type
OBSERVATIONAL
Sponsor
University of Leicester
Enrollment
50
Start date
2025-07-01
Completion date
2028-04-01
Last update
2026-08-17

Conditions

Summary

Uterine sarcoma

Detailed description

All participants will be asked questions about their demographics, medical and family history, and any symptoms. Additional information will be taken from their medical records, including information on medical, family and surgical history, the subtype of sarcoma and the pathology results. Information and images from any ultrasound, CT, MRI or PET scans that show the uterine sarcoma will also be collected. The original tumour biopsies will be reviewed by study team’s pathologist who will provide a second opinion on the subtype of sarcoma. A small piece of tumour taken at primary surgery or biopsy will be analysed to confirm the type of uterine sarcoma and may undergo genetic (DNA) analysis. If the tumour has undergone genetic sequencing through the NHS genomic medicine service, there results will be requested. Participants recruited at the University Hospitals of Leicester will be asked to give a blood sample (up to 20mls or 1.5 tablespoons) every 3 months, or each time they attend for a follow up appointment with the oncology team. If they are due to undergo chemotherapy treatment, they will be asked for a blood sample before each cycle of chemotherapy. If they are having radiotherapy or surgery, they will be asked for a blood sample before and after the course of treatment. At each follow-up visit the participants will be asked if they are having any symptoms, for example vaginal bleeding or pelvic pain. The results of any investigations to investigate suspected recurrence and/or response to chemotherapy/radiotherapy/surgery will be recorded along with any treatment that have been given for the uterine sarcoma. This will continue until the patient is discharged from follow up or the study finishes. The team will also obtain further information from the patients’ medical records through the NHS for up to ten years. The blood tests will be analysed aiming to identify genetic markers that can detect and/or predict uterine cancer recurrence. Participants and their d

Interventions

Inclusion criteria

1. Uterine sarcoma 2. Aged 18 years or older 3. Female

Exclusion criteria

1. Male 2. Under 18 years 3. Not previously undergone treatment for a uterine sarcoma

Locations

Related clinical trials

View on source registry