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

• Sponsor: Far Eastern Memorial Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01988376
• Collaborator: Gynecologic Oncology Group (Other)
• Enrollment: 258
• Location: 1
• Arms: 2
• Duration (Months): 32
• Patients Per Site Per Month: 8.1

Study Details

Study Description

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	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 258 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Screening
• Study Start Date: Mar 1, 2012
• Actual Primary Completion Date: Dec 1, 2013
• Actual Study Completion Date: Nov 1, 2014

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. the Percentage of Smears, That Were Difficulty in Making a Definite Diagnosis [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 99 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Far Eastern Memorial Hospital	Banqiao	New Taipei	Taiwan	22050

Sponsors and Collaborators

• Far Eastern Memorial Hospital
• Gynecologic Oncology Group

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sheng-Mou Hsiao, Chief, Department of Obstetrics & Gynecology, Far Eastern Memorial Hospital
• ClinicalTrials.gov Identifier: NCT01988376
• Other Study ID Numbers: 100140-E
• First Posted: Nov 20, 2013
• Last Update Posted: Jan 3, 2019
• Last Verified: Jul 1, 2015

• Additional relevant MeSH terms: Uterine Cervical Neoplasms

Study Results

Participant Flow

Arm/Group Title	Women With Cervical Cancer Receive Surepath for Screening	Women Receive Conventional Pap Smear for Screening
Arm/Group Description	Women will receive Surepath as a tool for screening the recurrence of cervical cancer. Surepath: A liquid-base method of Pap smear for screening the recurrence of cervical cancer	Women who will receive conventional Pap smear for screening Conventional Pap smear: Conventional Pap smear
Period Title: Overall Study
STARTED	129	129
COMPLETED	129	129
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Women With Cervical Cancer Receive Surepath for Screening	Women Receive Conventional Pap Smear for Screening	Total
Arm/Group Description	Women will receive Surepath as a tool for screening the recurrence of cervical cancer. Surepath: A liquid-base method of Pap smear for screening the recurrence of cervical cancer	Women who will receive conventional Pap smear for screening Conventional Pap smear: Conventional Pap smear	Total of all reporting groups
Overall Participants	129	129	258
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	57.44 (11.44)	58.50 (8.13)	57.97 (9.79)
Sex/Gender, Customized (participants) [Number]
Number [participants]	129 100%	129 100%	258 100%

Outcome Measures

1. Primary Outcome

Title	the Percentage of Smears, That Were Difficulty in Making a Definite Diagnosis
Description	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
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

Patients with cervical cancer who received radiation therapy

Arm/Group Title	Women Received Surepath for Screening	Women Received Conventional Pap Smear for Screening
Arm/Group Description	Women who received Surepath for screening the recurrence of cervical cancer.	Women who received conventional Pap smear for screening the recurrence of cervical cancer.
Measure Participants	18	21
Number [percentage of smears]	0	0

Adverse Events

Time Frame	3 months
Arm/Group Title	Women With Cervical Cancer Receive Surepath for Screening		Women Receive Conventional Pap Smear for Screening
Arm/Group Description	Women will receive Surepath as a tool for screening the recurrence of cervical cancer. Surepath: A liquid-base method of Pap smear for screening the recurrence of cervical cancer		Women who will receive conventional Pap smear for screening Conventional Pap smear: Conventional Pap smear
All Cause Mortality
	Women With Cervical Cancer Receive Surepath for Screening		Women Receive Conventional Pap Smear for Screening
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Women With Cervical Cancer Receive Surepath for Screening		Women Receive Conventional Pap Smear for Screening
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/129 (0%)		0/129 (0%)
Other (Not Including Serious) Adverse Events
	Women With Cervical Cancer Receive Surepath for Screening		Women Receive Conventional Pap Smear for Screening
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/129 (0%)		0/129 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.