Comparing the Rate of Insufficient Cells for Diagnosis Between Surepath® and Conventional Smear in Women After Radiation Therapy for Cervical Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Conditions
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Cervical Cancer

Intervention / Treatment
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* Device: Surepath
* Device: Conventional Pap smear


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All women who had received radiotherapy for cervical cancer in our outpatient clinics. Prior to joining test subjects for 90 days or more earlier had received a complete pelvic radiation therapy, including treatment of the cervix or vagina. Subjects with radiation therapy (including combined chemical and radiation therapy or postoperative adjuvant [chemical] radiation therapy) for their first treatment. Exclusion Criteria: recurrence of cervical cancer hormone treatment within 90 days vaginal vault or cervix topical treatment within 90 days. Subjects had or now have other malignancies

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Women with cervical cancer receive Surepath for screening<br>Women will receive Surepath as a tool for screening the recurrence of cervical cancer. | Device: Surepath<br>* A liquid-base method of Pap smear for screening the recurrence of cervical cancer<br>|
| Active Comparator: Women receive conventional Pap smear for screening<br>Women who will receive conventional Pap smear for screening | Device: Conventional Pap smear<br>* Conventional Pap smear<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the Percentage of Smears, That Were Difficulty in Making a Definite Diagnosis | 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 | 1 year |