Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
2000 participants
OBSERVATIONAL
2022-03-01
2023-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients with postmenopausal bleeding
Patients attending a gynaecology clinic for investigation of postmenopausal bleeding and undergoing a transvaginal ultrasound (TVUS).
MCM5 ELISA
ADXGYNAE is a non-invasive ELISA utilising a combination of two monoclonal antibodies for the detection of MCM5 in urine sediment. It is intended to aid in the detection of endometrial cancer in women with postmenopausal bleeding who are suspected of having endometrial cancer. Participants will be asked to provide a urine specimen, which will be centrifuged before the sediment is lysed. The lysed sample will then be tested with the MCM5 ELISA.
Interventions
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MCM5 ELISA
ADXGYNAE is a non-invasive ELISA utilising a combination of two monoclonal antibodies for the detection of MCM5 in urine sediment. It is intended to aid in the detection of endometrial cancer in women with postmenopausal bleeding who are suspected of having endometrial cancer. Participants will be asked to provide a urine specimen, which will be centrifuged before the sediment is lysed. The lysed sample will then be tested with the MCM5 ELISA.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients who are at least 1 year post-menopausal i.e. have not had a menstrual period for at least one year
* Patients who, in the opinion of the Investigator, are suitable for standard gynaecological investigations as part of normal clinical practice
* Patients who are, in the opinion of the Investigator, able to understand the purpose of the study and provide a full void urine specimen
* Patients who are able to give voluntary, written informed consent to participate in this study and from whom consent has been obtained
Exclusion Criteria
* Patients currently undergoing chemotherapy or radiotherapy
* Patients who have previously been diagnosed with bladder or renal cancer who are currently in follow up
* Patients with a medical contraindication to endometrial biopsy
* Patients who do not wish to have an endometrial biopsy even if deemed necessary by the treating physician
* Patients who have had urological instrumentation to the urinary tract within 14 days prior to the test (including catheterisation)
* Patients who have had any gynaecological instrumentation in the previous 14 days
18 Years
FEMALE
No
Sponsors
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Arquer Diagnostics Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Professor Richard Edmondson, MD
Role: PRINCIPAL_INVESTIGATOR
Central Manchester NHS Foundation Trust
Locations
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Saint Mary's Hospital, Central Manchester NHS Foundation Trust
Manchester, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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References
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Stockley J, Akhand R, Kennedy A, Nyberg C, Crosbie EJ, Edmondson RJ. Detection of MCM5 as a novel non-invasive aid for the diagnosis of endometrial and ovarian tumours. BMC Cancer. 2020 Oct 15;20(1):1000. doi: 10.1186/s12885-020-07468-y.
Other Identifiers
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AQ010
Identifier Type: -
Identifier Source: org_study_id
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