NCT01988376

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 258 (actual)
• Sponsor: Far Eastern Memorial Hospital · Academic / Other
• Sex: Female
• Age: 20 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

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

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

• Cervical Cancer

Interventions

Type	Name	Description
DEVICE	Surepath	A liquid-base method of Pap smear for screening the recurrence of cervical cancer
DEVICE	Conventional Pap smear	Conventional Pap smear

Timeline

• Start date: 2012-03-01
• Primary completion: 2013-12-01
• Completion: 2014-11-01
• First posted: 2013-11-20
• Last updated: 2019-01-03
• Results posted: 2018-11-20

Locations

1 site across 1 country: Taiwan