Triage for the investigation of endometrial cancer in patients with post-menopausal bleeding Cancer
Conditions
Interventions
Bleeding after menopause can be a sign of womb cancer and people with this symptom typically undergo transvaginal ultrasound scan +/- a hysteroscopy and biopsy to rule out womb cancer. These tests are
Sponsors
University of Manchester
Eligibility
Sex/Gender
Female
Age
18 Years to 110 Years
Inclusion criteria
Inclusion criteria: 1. Women referred to secondary care for investigation of postmenopausal bleeding* 2. Written, informed consent to participate 3. Minimum transvaginal ultrasound dataset available** *Postmenopausal bleeding will be defined as vaginal bleeding more than 12 months after menstruation has stopped due to menopause. ** Applicable only to participants approached for recruitment after transvaginal scan performed as part of their current PMB investigations.
Exclusion criteria
Exclusion criteria: 1. Previous treatment for endometrial cancer 2. Previous hysterectomy 3. Unable to collect a urine sample
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The ability of the PREDICT EC model to predict probabilities that match observed outcomes measured using standard endometrial cancer diagnostic tests including transvaginal ultrasound (at the threshold which would prompt further investigation, defined by national guidelines), hysteroscopy and endometrial biopsy at final clinical outcome | — |
Secondary
| Measure | Time frame |
|---|---|
| Performance of each risk score measured using cancer type and demographics (i) atypical hyperplasia, (ii) endometrial cancers of different molecular subtypes: DNA polymerase epsilon-mutated (POLE mutant), mismatch repair (MMR) deficient, p53 abnormal and no specific molecular profile (NSMP), (iii)FIGO stage, (iv)above and below age 55 years, (v) Indices of Multiple Deprivation (IMD) quintile groups based on postcode, (vi) self-reported ethnicity at final clinical outcome;Clinical utility of a risk score measured using a decision curve analysis at final clinical outcome;Patient acceptability of PREDICT-EC compared to standard care measured using a non-validated questionnaire at baseline;The ability of the WID-easy test to predict probabilities that match observed outcomes measured using standard endometrial cancer diagnostic tests at final outcome;The ability of the blood and urine spectroscopy to predict probabilities that match observed outcomes measured using standard endometrial cancer diagnostic tests at final outcome;Patient acceptability of WID-easy and spectroscopy sampling methods (urine, blood, vaginal swab) compared to standard care measured using a non-validated questionnaire at baseline | — |
Countries
England, Scotland, United Kingdom, Wales
Contacts
Public ContactSuzanne Carter
Outcome results
None listed