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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
Last Update Posted : April 1, 2014
Sponsor:
Collaborator:
Taiwan Association of Gynecologic Oncologists
Information provided by (Responsible Party):
Far Eastern Memorial Hospital

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.


Condition or disease Intervention/treatment Phase
Cervical Cancer Device: Surepath Device: Conventional Pap smear Phase 4

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Study Start Date : March 2012
Actual Primary Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

Arm Intervention/treatment
Experimental: Women with cervical cancer receive Surepath for screening
Women will receive Surepath as a tool for screening the recurrence of cervical cancer.
Device: Surepath
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




Primary Outcome Measures :
  1. The Rate of Insufficient vaginal Cells for Diagnosis [ Time Frame: 1 year ]
    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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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
Taiwan
Far Eastern Memorial Hospital
Banqiao, New Taipei, Taiwan, 22050
Sponsors and Collaborators
Far Eastern Memorial Hospital
Taiwan Association of Gynecologic Oncologists

Responsible Party: Far Eastern Memorial Hospital
ClinicalTrials.gov Identifier: NCT01988376     History of Changes
Other Study ID Numbers: 100140-E
First Posted: November 20, 2013    Key Record Dates
Last Update Posted: April 1, 2014
Last Verified: November 2013

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female