Clinical trial · Interventional
Comparing the Rate of Insufficient Cells for Diagnosis Between Surepath® and Conventional Smear in Women After Radiation Therapy for Cervical Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Conventional Pap smear | Device | — | UNRESOLVED |
| Surepath | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Women with cervical cancer receive Surepath for screening
- description
- Women will receive Surepath as a tool for screening the recurrence of cervical cancer.
- interventionNames
- Device: Surepath
- type
- ACTIVE_COMPARATOR
- label
- Women receive conventional Pap smear for screening
- description
- Women who will receive conventional Pap smear for screening
- interventionNames
- Device: Conventional Pap smear
Primary outcomes (1)
- measure
- the Percentage of Smears, That Were Difficulty in Making a Definite Diagnosis
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 99 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available