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

NCT ID: NCT01988376

Last Updated: 2019-01-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 258 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2014-11-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Women with cervical cancer receive Surepath for screening

Women will receive Surepath as a tool for screening the recurrence of cervical cancer.

Group Type: EXPERIMENTAL

Surepath

Intervention Type: DEVICE

A liquid-base method of Pap smear for screening the recurrence of cervical cancer

Women receive conventional Pap smear for screening

Women who will receive conventional Pap smear for screening

Group Type: ACTIVE_COMPARATOR

Conventional Pap smear

Intervention Type: DEVICE

Conventional Pap smear

Interventions

Surepath

A liquid-base method of Pap smear for screening the recurrence of cervical cancer

Intervention Type: DEVICE

Conventional Pap smear

Conventional Pap smear

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. All women who had received radiotherapy for cervical cancer in our outpatient clinics.

2. 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.

3. Subjects with radiation therapy (including combined chemical and radiation therapy or postoperative adjuvant [chemical] radiation therapy) for their first treatment.

Exclusion Criteria

1. recurrence of cervical cancer

2. hormone treatment within 90 days

3. vaginal vault or cervix topical treatment within 90 days.

4. Subjects had or now have other malignancies

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Gynecologic Oncology Group

NETWORK

Sponsor Role: collaborator

Far Eastern Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Sheng-Mou Hsiao

Chief, Department of Obstetrics & Gynecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Far Eastern Memorial Hospital

Banqiao District, New Taipei, Taiwan

Countries

Taiwan

Other Identifiers

100140-E

Identifier Type: -

Identifier Source: org_study_id