- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04461574
Orcellex® Brush Versus Cervex-Brush® on Vault Smear Adequacy in Patients Treated With Radiotherapy for Cervical Cancer
Clinical Trial Comparing the Use of Orcellex® Brush Versus Cervex-Brush® on Vaginal Vault Smear Cytology Adequacy Rate in Patients Treated With Radiotherapy for Cervical Cancer
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Patients with cervical cancer treated with primary irradiation will be recruited at their routine post-treatment surveillance follow-up in the out-patient clinic, in the order of their appointment time. Study procedure will be explained and written informed consent is obtained from each subject at the visit. Systemic and vaginal examination will be carried out as usual. Subjects will receive vaginal vault smear by both Cervex-Brush® and Orcellex® Brush during the same speculum examination. The order of using smear sampling devices will be randomized. Randomization will be carried out according to computer-generated random numbers, allocated by sequentially numbered, sealed opaque envelopes. Subjects will be randomized into two groups: using Cervex-Brush® first followed by Orcellex® Brush, or vice versa. The procedure of smear taking will be carried out by four trained clinicians who are independent of the study. The method of smear taking will be standardized for both Cervex-Brush® and Orcellex® Brush. The vaginal vault will be swept horizontally by the brush and the cervical dimple, if seen, will be rotated five times by the brush. Each sampling device will be shaken vigorously in separate Thinprep specimen containers, which is labelled as smear A for Cervex-Brush® and smear B for Orcellex® Brush.
The subjects are unaware of the sequence of the sampling device used, as they cannot see the procedure of smear taking during examination. The patient will be asked about the pain score during each smear taking, by using the visual analog scale. Any vaginal bleeding will be recorded.
The specimen will be sent to the laboratory and will be processed by the ThinPrep method. The cytopathologist is unaware as to which device is used for that particular specimen and the slide prepared from it. One pathologist will be responsible in screening all the vault smears involved in this study. Adequacy of vault smear sample was defined by the Bethesda System as a minimum of 2000 well-visualized and well-preserved squamous cells.
Patients will be arranged subsequent follow-up visits at appropriate time interval according to the department protocol. Patients with inadequate smear result by both sampling devices will be called back early within 8 weeks for repeat smear using the conventional Cervex-Brush®.
Patients with cervical cancer in the department will have surveillance follow-ups at variable intervals from 3 months to 12 months, depending on the time interval from previous treatment and patients' symptoms. Some patients may have repeated smears during the study period. As the result of previous smear will have no impact on the adequacy rate of subsequent smear, patients can be recruited for smear taking more than once in the study. Hence the actual number of patients recruited in the study would be less than the calculated sample size of 160.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mung Yuen He, MBBS
- Phone Number: 85262403147
- Email: hmy703@ha.org.hk
Study Locations
-
-
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Hong Kong, Hong Kong, 000
- Recruiting
- Princess Margaret Hospital
-
Contact:
- Mung Yuen He, MBBS
- Phone Number: 85262403147
- Email: hmy703@ha.org.hk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients with cervical cancer treated with primary radiotherapy
- Patients aged 18 years or older
- Patients requiring vaginal vault cytology for follow-up surveillance
Exclusion Criteria:
- Patients who refuse vaginal examination or vaginal vault smear at follow-up.
- Patients who have visible tumour at vaginal vault requiring direct biopsy at speculum examination.
- Patients who cannot understand the study purpose and procedure.
- Patients who cannot read the words written in Chinese or English.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: Cervex Brush
|
Subjects will receive vaginal vault smear using both Orcellex Brush and Cervex Brush at the same follow-up visit, with order of smear taking decided by randomization.
|
ACTIVE_COMPARATOR: Orcellex Brush
|
Subjects will receive vaginal vault smear using both Orcellex Brush and Cervex Brush at the same follow-up visit, with order of smear taking decided by randomization.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Vault cytology adequacy rate
Time Frame: through study completion, an average of 1 year
|
Adequacy of vault smear sample was defined by the Bethesda System as a minimum of 2000 well-visualized and well-preserved squamous cells
|
through study completion, an average of 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient pain score
Time Frame: through study completion, an average of 1 year
|
Pain score 0-10 by visual analog scale higher score means higher level of pain minimum = 0 maximum = 10
|
through study completion, an average of 1 year
|
Vaginal bleeding
Time Frame: through study completion, an average of 1 year
|
Any bleeding noted by investigators during per vaginal examination
|
through study completion, an average of 1 year
|
Detection of abnormal cytology
Time Frame: through study completion, an average of 1 year
|
Any detection of abnormal cells by vault cytology
|
through study completion, an average of 1 year
|
borderline cellularity rate
Time Frame: through study completion, an average of 1 year
|
borderline cellularity requiring further clarification
|
through study completion, an average of 1 year
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 147-06
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cervical Cancer
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University of California, San DiegoWithdrawnCervical Cancer | Cervical Cancer Stage | Cervical Cancer Stage IB2 | Cervical Cancer Stage IB1 | Cervical Cancer Stage I | Cervical Cancer Stage IB | Cervical Cancer Stage II | Cervical Cancer Stage IIa | Cervical Cancer, Stage IIB | Cervical Cancer, Stage III | Cervical Cancer Stage IIIB | Cervical Cancer... and other conditionsUnited States
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M.D. Anderson Cancer CenterWithdrawnStage IB3 Cervical Cancer FIGO 2018 | Stage II Cervical Cancer FIGO 2018 | Stage IIA Cervical Cancer FIGO 2018 | Stage IIA1 Cervical Cancer FIGO 2018 | Stage IIA2 Cervical Cancer FIGO 2018 | Stage IIB Cervical Cancer FIGO 2018 | Stage III Cervical Cancer FIGO 2018 | Stage IIIA Cervical Cancer FIGO... and other conditions
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Abramson Cancer Center of the University of PennsylvaniaWithdrawnCervical Cancer | Stage IB Cervical Cancer | Stage IIA Cervical Cancer | Stage IIB Cervical Cancer | Stage III Cervical Cancer | Stage IVA Cervical Cancer
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National Cancer Institute (NCI)CompletedCervical Adenocarcinoma | Cervical Squamous Cell Carcinoma | Stage IB Cervical Cancer | Stage IIA Cervical Cancer | Stage IIB Cervical Cancer | Stage III Cervical Cancer | Stage IVA Cervical Cancer | Stage IVB Cervical CancerUnited States
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingStage IA Cervical Cancer | Stage IB Cervical Cancer | Stage IA1 Cervical Cancer | Stage IA2 Cervical Cancer | Stage IB1 Cervical Cancer | Stage IB2 Cervical Cancer | Stage IB3 Cervical CancerUnited States
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Mayo ClinicNational Cancer Institute (NCI)RecruitingCervical Adenosquamous Carcinoma | Cervical Squamous Cell Carcinoma, Not Otherwise Specified | Recurrent Cervical Carcinoma | Stage IB3 Cervical Cancer FIGO 2018 | Stage II Cervical Cancer FIGO 2018 | Stage IIA Cervical Cancer FIGO 2018 | Stage IIA1 Cervical Cancer FIGO 2018 | Stage IIA2 Cervical... and other conditionsUnited States
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Shanghai First Maternity and Infant HospitalNot yet recruitingCervical Cancer, Stage IIB | Cervical Cancer Stage IIIB | Cervical Cancer Stage IIIA | Cervical Cancer, Stage IVA
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University of Southern CaliforniaNational Cancer Institute (NCI)CompletedRecurrent Cervical Cancer | Stage IVA Cervical Cancer | Stage IVB Cervical Cancer | Stage IIIA Cervical Cancer | Stage IIIB Cervical CancerUnited States
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Gynecologic Oncology GroupNational Cancer Institute (NCI)CompletedCervical Adenocarcinoma | Cervical Squamous Cell Carcinoma | Stage IB Cervical Cancer | Stage IIA Cervical Cancer | Stage IIB Cervical Cancer | Stage III Cervical Cancer | Stage IVA Cervical CancerUnited States
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Institut de Cancérologie de LorraineCompletedCervical Adenocarcinoma | Stage IB Cervical Cancer | Stage III Cervical Cancer | Stage II Cervical CancerFrance
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