Endometrial cancer Cancer
Conditions
Interventions
After written informed consent, the trialists will obtain medical history and matched urine and vaginal samples from women with unexplained postmenopausal bleeding. Urine samples will be self collect
Sponsors
Manchester University Hospital NHS Foundation Trust
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Women with unexplained postmenopausal bleeding attending for urgent investigations to exclude endometrial cancer 2. Written informed consent to participate
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 21/12/2018: 1. Abnormal bleeding before the menopause (in whom the risk of cancer is much lower) 2. Previous diagnosis of endometrial cancer 3. Previous hysterectomy 4. Mirena coil in situ or removed within the last 3 months 5. Any other condition that would compromise participant safety or data integrity Previous exclusion criteria: 1. Abnormal bleeding before the menopause (in whom the risk of cancer is much lower) 2. Previous diagnosis of endometrial cancer 3. Previous hysterectomy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sensitivity: the proportion of women who have endometrial cancer who test positive by urogenital cytology (true positive rate) and negative predictive value – the proportion of test negatives who are true negatives. The accuracy of urine +/- vaginal cytology (index test) will be defined by the results of standard endometrial cancer diagnostic tests | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Specificity: the proportion of women who do not have endometrial cancer who test negative by urogenital cytology (true negative rate) 2. False positive/negative rates (including clinical scenarios associated with these) 3. Positive predictive value 4. Test acceptability (short questionnaire to compare acceptability of urogenital cytology with standard diagnostic tests) Exploratory analyses beyond the scope of this study: The trialists will collect the residual urogenital cytology samples and store them in the MFT Biobank for future biomarker discovery work. They will centrifuge the samples to pellet the cellular material and freeze the pellet plus an aliquot of the supernatant. | — |
Countries
England, United Kingdom
Contacts
Public ContactSuzanne Carter
Outcome results
None listed