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Evaluation of MCM5 in Postmenopausal Bleeding Patients

NCT05287048UNKNOWNOBSERVATIONAL

Summary

The objective of this multi-centre, prospective study, is to evaluate the performance of a urine MCM5 ELISA test (ADXGYNAE) in the detection of endometrial cancer in patients with postmenopausal bleeding. Patients attending a gynaecology clinic for investigation of postmenopausal bleeding will be recruited and asked to provide a urine sample to be tested. The results of the MCM5 test will be recorded and compared to the patient's routine investigations to determine the clinical utility of the test as an aid in the diagnosis of endometrial cancer.

Key Facts

Lead Sponsor

Arquer Diagnostics Ltd

Enrollment

2000

Start Date

2022-03-01

Completion Date

2023-09-01

Study Type

OBSERVATIONAL

Official Title

A Performance Evaluation Study of Arquer Diagnostics Ltd's MCM5 ELISA (ADXGYNAE) Test to Aid in the Diagnosis of Endometrial Cancer

Interventions

MCM5 ELISA

Conditions

Endometrial Cancer

Eligibility

Age Range

18 Years+

Sex

FEMALE

Inclusion Criteria:

* Patients 18 years of age or older
* 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 with known symptomatic calculi within the urino-genitary system
* 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

Outcome Measures

Primary Outcomes

Sensitivity, specificity and negative predictive value (NPV) of ADXGYNAE will be calculated to establish the diagnostic accuracy for the detection of endometrial cancer.

The MCM5 test result will be compared with data obtained from patient's standard of care clinical investigations, including results from transvaginal ultrasound (TVUS) and endometrial biopsy or hysteroscopy. A definitive diagnosis of endometrial cancer will be confirmed by the presence of histologically proven endometrial cancer on resection/biopsy. Patients who do not have an endometrial biopsy will be followed up at 6 months to identify if further investigations were carried out.

Time frame: 1 year

Locations

Saint Mary's Hospital, Central Manchester NHS Foundation Trust, Manchester, United Kingdom

Linked Papers

2020-10-15

Detection of MCM5 as a novel non-invasive aid for the diagnosis of endometrial and ovarian tumours

AbstractBackgroundMCM5 is a protein involved in DNA replication, facilitating cell proliferation. In normal epithelium MCM5 expression is restricted to the cells in the basal proliferative compartments, however in the presence of a tumour MCM5 positive cells are present at the surface epithelium and are shed into bodily fluids. The aim of this study was to determine the sensitivity of MCM5 as a biomarker for the detection of endometrial and ovarian cancer.MethodsPatients with known ovarian or endometrial cancers, or known benign gynaecological conditions, were enrolled. Informed consent was obtained prior to the collection of full void urine, and either a vaginal tampon (worn for 6–8 h), or a vaginal swab. Vaginal secretions were extracted from the tampon or swab, centrifuged and lysed. Urine samples were centrifuged and lysed. MCM5 levels were determined by MCM5-ELISA (Arquer Diagnostics Ltd).Results125 patients completed the study protocol, 41 patients had endometrial cancer, 26 ovarian cancer, and 58 benign controls. All patients provided a urine sample and either a tampon or vaginal swab sample. Urine MCM5 levels were higher in cancer patients than controls (p < 0.0001), there was no significant difference in levels between tampon samples or vaginal swab samples in cancer patients when compared to controls.Performance of MCM5 to discriminate cancer from benign disease was high with an area under the ROC curve of 0.83 for endometrial cancer and 0.68 for ovarian cancer. Using a cut off of 12 pg/mL, overall sensitivity for endometrial cancer was 87.8, and 61.5% for ovarian cancer with a specificity of 75.9%.ConclusionsMCM5 is a novel sensitive and specific biomarker for the detection of ovarian and endometrial tumours in urine samples, which is likely to have clinical utility as a diagnostic aid.

Linked Investigators

Richard Edmondson