Far Eastern Memorial Hospital
Banqiao District, New Taipei, 22050, Taiwan
NCT Number: NCT01988376
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.
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Notify Me20 year–99 year
Female
Interventional
Not applicable
Banqiao District, New Taipei, 22050, Taiwan
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A liquid-base method of Pap smear for screening the recurrence of cervical cancer
Conventional Pap smear
Time frame: 1 year
Comparing the percentage of smears, that were difficulty in making a definite diagnosis from smear owing to insufficient cells, between Surepath® and Conventional Smear in Women after Radiation Therapy for Cervical Cancer
Far Eastern Memorial Hospital
Other
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