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Completed

NCT Number: NCT01988376

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

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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Key information

Age range

20 year–99 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Far Eastern Memorial Hospital

Banqiao District, New Taipei, 22050, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Surepath

Device

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

Conventional Pap smear

Device

Conventional Pap smear

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Far Eastern Memorial Hospital

Other

Collaborators

  • Gynecologic Oncology Group

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Nov 20, 2013
Registry last updated
Jan 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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