Cervical Cancer Clinical Trial
Background/Purpose: This is a large scale, multicenter randomized clinical trial to assess
the feasibility of using SurePath® in cervical cancer patients after radiation therapy by
comparing the incidence of unsatisfactory smear and the accuracy of detecting cervicovaginal
lesions between the SurePath® and the conventional smear.
Patients and Methods: The investigators will invite all women who had received radiotherapy
for cervical cancer in the investigators outpatient clinics. All enrolled cases will ask to
receive randomly the SurePath® or the conventional smear.
Expected Results: The investigators will get the incidence of unsatisfactory smear and the
accuracy of detecting cervicovaginal lesions between the SurePath® and the conventional smear
in patients who underwent radiotherapy.
Adequate specimen (specimen adequacy) is cervical or vaginal cytology single most important
quality factors. 2001 Pap Bethesda System classification maintain its previous version, the
Pap specimen is divided into satisfactory assessment and unsatisfactory evaluation two kinds;
meet "satisfactory assessments "specimen standard, conventional Pap (conventional smear)
requires at least 8,000-12,000-readable squamous cells, and liquid-based Pap (liquid-based
smear) you need at least 5,000-readable squamous cell .
For squamous cell samples were determined to be adequate, yet to record their specimens have
intrauterine neck or squamous transitional zone (transformation zone) border zone cells
exist; quality indicators "Cell interpretation in part by inflammation or blood masking noise
"of the specimen, if it can not be sentenced to 50-75% of epithelial cells can still be
classified as read" satisfied "with the specimen, while more than 75% of the epithelial cells
are obscured interference specimen is classified in the" unsatisfactory "specimen.
;
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