EVALUATION OF MCM5 ELISA IN THE DIAGNOSIS OF GYNAECOLOGICAL MALIGNANCY
Research type
Research Study
Full title
Evaluation of minimally invasive methods of sample collection in combination with a MCM5 ELISA in the diagnosis of ovarian and endometrial cancer.
IRAS ID
210148
Contact name
Richard Edmondson
Contact email
Sponsor organisation
Arquer Diagnostics
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
Arquer's intention is to develop simple, rapid, non-invasive tests that will help clinicians to make an assessment of the likelihood of patients having a gynaecological malignancy. Currently there are no successful screening tools for the diagnosis of ovarian or endometrial cancer.
It is the objective of this study to establish if MCM5, a protein which is expressed in cancer cells, is detectable in samples taken from patients with Ovarian or Endometrial cancer. Research has shown that the presence of MCM5 in the urine sediment is a sensitive and specific test for bladder and prostate cancer. Recent research has shown that cancer cells from ovarian and endometrial tumours can be shed through the vagina. Therefore Arquer wish to test if these cells can be detected using the MCM5 test in either the urine, with vaginal swabs, or on a vaginal tampon of patients with ovarian and endometrial cancer.
Patients will be asked to provide a urine sample, and either a vaginal swab taken, or asked to provide a vaginal tampon. Both samples will be tested for MCM5 using Arquer’s MCM5 ELISA and compared to the standard clinical investigation results in order to establish the utility of the MCM5 ELISA. Each sample collection method will be compared to determine which is the most effective, and least invasive for the patient. The results of the Mcm5 ELISA test will in no way influence the treatment of the patient.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
16/SC/0643
Date of REC Opinion
22 Nov 2016
REC opinion
Favourable Opinion