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Not yet recruiting NCT07581288

Measurement of Urinary Hormones in Patients With Abnormal Uterine Bleeding to Study Uterine Cancer Progression

Observational Uterine Bleeding Uterine Cancer Uterine Neoplasms Endometrial Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Uterine Bleeding, Uterine Cancer, Uterine Neoplasms, Endometrial Cancer. Basic parameters: from 35 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Quantitative Hormonal Biomarkers of Uterine Cancer Progression in Patients With Abnormal Uterine Bleeding

Overview

The investigators will obtain urine hormone results and validated menstrual bleeding score from people experiencing abnormal uterine bleeding. The investigators will evaluate satisfaction and ease of use of Mira monitor. The investigators will measure recruitment rate, attrition and cycle collection completeness of data. The investigators will evaluate menstrual health literacy at baseline and at the conclusion of the study.

Primary outcome measures

  • Urinary Hormone Levels (Mira Monitor) [Time frame: 3 months]
  • Menstrual Bleeding Severity [Time frame: 3 months]
  • Acceptability and Feasibility of Mira Monitor [Time frame: 3 months]

Eligibility criteria

Inclusion criteria

  • 35 years and older
  • Have experienced AUB

Exclusion criteria

  • Currently pregnant or become pregnant during their participation
  • Previous surgeries impairing the menstrual cycle (e.g. hysterectomy, bilateral oophorectomy)
  • Currently or in the previous 3 months on medications that are known to impair or stimulate ovulation (e.g. oral contraceptives, ovulation stimulants, hormone replacement, etc.)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Canada · 1 center
  • Vancouver General Hospital Research Pavillion — Vancouver

Identifiers

NCT: NCT07581288 · H24-03180

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗