Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Gynecologic Oncology Group | NETWORK |
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Women with cervical cancer receive Surepath for screening | Experimental | Women will receive Surepath as a tool for screening the recurrence of cervical cancer. |
|
| Women receive conventional Pap smear for screening | Active Comparator | Women who will receive conventional Pap smear for screening |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surepath | Device | A liquid-base method of Pap smear for screening the recurrence of cervical cancer |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Far Eastern Memorial Hospital | Banqiao District | New Taipei | 22050 | Taiwan |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Women Receive Conventional Pap Smear for Screening |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Conventional Pap smear | Device | Conventional Pap smear |
|
Women who will receive conventional Pap smear for screening Conventional Pap smear: Conventional Pap smear |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Women Receive Conventional Pap Smear for Screening | Women who will receive conventional Pap smear for screening Conventional Pap smear: Conventional Pap smear |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex/Gender, Customized | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Patients with cervical cancer who received radiation therapy | Posted | Number | percentage of smears | 1 year |
|
|
|
3 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 0 | 129 | 0 | 129 | ||
| EG001 | Women Receive Conventional Pap Smear for Screening | Women who will receive conventional Pap smear for screening Conventional Pap smear: Conventional Pap smear | 0 | 129 | 0 | 129 |
Not provided
Not provided
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hsiao, Sheng-Mou | Far Eastern Memorial Hospital | (02)89667000 | 1424 | smhsiao2@gmail.com |
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
Not provided
Not provided