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

NCT01988376 | Completed Results

• 1 other identifier: 100140-E
• Study Type: interventional
• Target: 258
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Cancer

Outcome Measures

Primary Outcomes (1)

• the Percentage of Smears, That Were Difficulty in Making a Definite Diagnosis

  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

  1 year

Study Arms (2)

Women with cervical cancer receive Surepath for screening

EXPERIMENTAL

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

Device: Surepath

Women receive conventional Pap smear for screening

ACTIVE COMPARATOR

Women who will receive conventional Pap smear for screening

Device: Conventional Pap smear

Interventions

Surepath DEVICE

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

Women with cervical cancer receive Surepath for screening

Conventional Pap smear DEVICE

Conventional Pap smear

Women receive conventional Pap smear for screening

Eligibility Criteria

• Age: 20 Years - 99 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Far Eastern Memorial Hospital: lead
• Gynecologic Oncology Group: collaborator

Study Sites (1)

Far Eastern Memorial Hospital

Banqiao District, New Taipei, 22050, Taiwan

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Results Point of Contact

• Title: Hsiao, Sheng-Mou
• Organization: Far Eastern Memorial Hospital

smhsiao2@gmail.com

(02)89667000

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Department of Obstetrics & Gynecology

Study Record Dates

• First Submitted: August 16, 2013
• First Posted: November 20, 2013
• Study Start: March 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: November 1, 2014
• Last Updated: January 3, 2019
• Results First Posted: November 20, 2018

Record last verified: 2015-07

Locations

TW (1)