Development of a bloodtest for uterine sarcoma monitoring
| ISRCTN | ISRCTN14174468 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14174468 |
| IRAS number | 350807 |
| Secondary identifying numbers | CPMS 65319 |
- Submission date
- 06/05/2025
- Registration date
- 04/06/2025
- Last edited
- 16/07/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
Uterine sarcomas are a rare type of cancer that occur in the uterus (womb). They are hard to diagnose because they share many symptoms with non-cancerous growths called fibroids. Currently, there is no blood test to help doctors monitor these cancers or detect if they come back. This study aims to develop a blood test that can detect fragments of cancer DNA in the blood to monitor uterine sarcomas.
Who can participate?
Patients who have been diagnosed with a uterine sarcoma and are under follow-up care can participate in this study.
What does the study involve?
Participants will have blood samples taken every 3 months. These samples will be analyzed to see if the new blood test can detect the return of uterine sarcoma. The study will also collect information from participants' medical records, including scan images and genetic analysis of their tumors.
What are the possible benefits and risks of participating?
Participants will not receive any direct benefits from taking part in this study. However, the results could help improve monitoring and treatment for future patients with uterine sarcoma. There are no significant risks involved in participating, but taking blood samples may cause minor discomfort.
Where is the study run from?
University of Leicester (UK)
When is the study starting and how long is it expected to run for?
April 2025 to April 2028
Who is funding the study?
The Eve Appeal (UK)
Who is the main contact?
Dr Esther Moss, leicestergcrg@le.ac.uk
Contact information
Public, Scientific, Principal Investigator
University of Leicester
Leicester
LE2 7LX
United Kingdom
 ORCID ID |
0000-0002-2650-0172 |
|---|---|
| leicestergcrg@le.ac.uk |
Study information
| Study design | Observational cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | 47284 DOORS-M PIS UHL V2 21.04.2025 clean.pdf |
| Scientific title | Development of a blOOdtest for uteRine Sarcoma – Monitoring (DOORS-M) |
| Study acronym | DOORS-M |
| Study objectives | To identify a genomic or methylation signature that could be used within a ctDNA ‘test’ to monitor uterine sarcomas |
| Ethics approval(s) |
Approved 12/05/2025, South Central - Berkshire B Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 (0)207 104 8029; berkshireb.rec@hra.nhs.uk), ref: 25/SC/0108 |
| Health condition(s) or problem(s) studied | Uterine sarcoma |
| Intervention | 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 doctors will not be informed of the result of the blood test. Participants may 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 monitor uterine sarcomas. This will take approximately 1 hour and will take place over the telephone or online using Microsoft (MS) Teams. The anonymised views and experiences will be compared with other women who are taking part in this study and will be used to help the research team understand the patient’s perspective. |
| Intervention type | Genetic |
| Primary outcome measure | 1. Body Mass Index (BMI) is measured using height and weight recorded with a stadiometer and calibrated scale at baseline (visit 1) 2. Uterine sarcoma diagnostic and treatment data are measured using clinical records review at baseline (visit 1) 3. Medical and family history is measured using patient interview and clinical records review at baseline (visit 1) 4. Symptom burden is measured using a symptom checklist questionnaire at baseline (visit 1) and approximately every 3 months 5. Circulating tumor DNA (ctDNA) presence is measured using a personalized, tumor-informed ctDNA assay (e.g. Signatera) from blood samples at baseline (visit 1) and approximately every 3 months |
| Secondary outcome measures | Patient experience of diagnosis, treatment, follow-up, and views on prognostic blood testing is measured using a semi-structured qualitative interview at any time following recruitment |
| Overall study start date | 23/04/2025 |
| Completion date | 01/04/2028 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 99 Years |
| Sex | Female |
| Target number of participants | 50 |
| Total final enrolment | 50 |
| Key inclusion criteria | 1. Uterine sarcoma 2. Aged 18 years or older 3. Female |
| Key exclusion criteria | 1. Male 2. Under 18 years 3. Not previously undergone treatment for a uterine sarcoma |
| Date of first enrolment | 01/07/2025 |
| Date of final enrolment | 28/03/2028 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Infirmary Square
Leicester
LE1 5WW
United Kingdom
Bristol Royal Infirmary
Marlborough Street
Bristol
BS2 8HW
United Kingdom
St Thomas Street
London
SE1 9RT
United Kingdom
Sponsor information
University/education
University Road
Leicester
LE1 7RH
England
United Kingdom
| Phone | +44 116 3736508 |
|---|---|
| RGOsponsor@le.ac.uk | |
| Website | https://le.ac.uk |
"ROR" |
https://ror.org/04h699437 |
Funders
Funder type
Charity
No information available
Results and Publications
| Intention to publish date | 01/04/2028 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in peer-reviewed journals |
| IPD sharing plan | Data sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 2 | 21/04/2025 | 04/06/2025 | No | Yes |
Additional files
Editorial Notes
16/07/2025: Internal review.
09/07/2025: Ethics approval details added.
04/06/2025: Trial's existence confirmed by NHS HRA.
