N/A N=258 Randomized Screening

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

Cervical Cancer

Bottom Line

View on ClinicalTrials.gov: NCT01988376 ↗

Enrolled (actual)

258

Serious AEs

0.0%

Results posted

Nov 2018

Primary outcome: Primary: the Percentage of Smears, That Were Difficulty in Making a Definite Diagnosis — 0; 0 percentage of smears

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Surepath (Device); Conventional Pap smear (Device)
Age: Adult, Older Adult · 20+ yrs
Sex: Female
Sponsor: Far Eastern Memorial Hospital
Primary completion: Dec 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY the Percentage of Smears, That Were Difficulty in Making a Definite Diagnosis	0; 0	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01988376). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.