Comparing the Rate of Insufficient Cells for Diagnosis Between Surepath® and Conventional Smear in Women After Radiation Therapy for Cervical Cancer
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|ClinicalTrials.gov Identifier: NCT01988376|
Recruitment Status : Completed
First Posted : November 20, 2013
Results First Posted : November 20, 2018
Last Update Posted : November 20, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Cervical Cancer||Device: Surepath Device: Conventional Pap smear||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||258 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||March 2012|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||November 2014|
Experimental: Women with cervical cancer receive Surepath for screening
Women will receive Surepath as a tool for screening the recurrence of cervical cancer.
A liquid-base method of Pap smear for screening the recurrence of cervical cancer
Active Comparator: Women receive conventional Pap smear for screening
Women who will receive conventional Pap smear for screening
Device: Conventional Pap smear
Conventional Pap smear
- the Percentage of Smears, That Were Difficulty in Making a Definite Diagnosis [ 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01988376
|Far Eastern Memorial Hospital|
|Banqiao, New Taipei, Taiwan, 22050|