Trial Outcomes & Findings for Comparing the Rate of Insufficient Cells for Diagnosis Between Surepath® and Conventional Smear in Women After Radiation Therapy for Cervical Cancer (NCT NCT01988376)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

258 participants

Primary outcome timeframe

1 year

Results posted on

2019-01-03

Participant Flow

Participant milestones

Participant milestones
Measure	Women With Cervical Cancer Receive Surepath for Screening 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 Receive Conventional Pap Smear for Screening Women who will receive conventional Pap smear for screening Conventional Pap smear: Conventional Pap smear
Overall Study STARTED	129	129
Overall Study COMPLETED	129	129
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Women With Cervical Cancer Receive Surepath for Screening n=129 Participants 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 Receive Conventional Pap Smear for Screening n=129 Participants Women who will receive conventional Pap smear for screening Conventional Pap smear: Conventional Pap smear	Total n=258 Participants Total of all reporting groups
Age, Continuous	57.44 years STANDARD_DEVIATION 11.44 • n=5 Participants	58.50 years STANDARD_DEVIATION 8.13 • n=7 Participants	57.97 years STANDARD_DEVIATION 9.79 • n=5 Participants
Sex/Gender, Customized	129 participants n=5 Participants	129 participants n=7 Participants	258 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Population: Patients with cervical cancer who received radiation therapy

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

Outcome measures

Outcome measures
Measure	Women Received Surepath for Screening n=18 Participants Women who received Surepath for screening the recurrence of cervical cancer.	Women Received Conventional Pap Smear for Screening n=21 Participants Women who received conventional Pap smear for screening the recurrence of cervical cancer.
the Percentage of Smears, That Were Difficulty in Making a Definite Diagnosis	0 percentage of smears	0 percentage of smears

Adverse Events

Women With Cervical Cancer Receive Surepath for Screening

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Women Receive Conventional Pap Smear for Screening

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Hsiao, Sheng-Mou

Far Eastern Memorial Hospital

Phone: (02)89667000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place