Cervical CancerNCT04461574
Orcellex® Brush Versus Cervex-Brush® on Vault Smear Adequacy in Patients Treated With Radiotherapy for Cervical Cancer
A study testing Orcellex Brush and Cervex Brush in people with Cervical Cancer, run by Princess Margaret Hospital, Hong Kong at 1 site in Hong Kong.
Trial summary
Vaginal vault cytology is commonly used for follow-up surveillance in patients treated for cervical cancer. It is known that the smear inadequacy rate is high, especially in patients post-radiotherapy at 10%. The current practice is to use Cervex-Brush®, which was designed for cervical smear taking. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Orcellex Brush and Cervex Brush
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jul 2020to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with cervical cancer treated with primary radiotherapy
- Patients aged 18 years or older
- Patients requiring vaginal vault cytology for follow-up surveillance
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Princess Margaret Hospital
Hong Kong, 000
Mung Yuen He, MBBS, 85262403147, hmy703@ha.org.hk
About this study
Official title: 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
Vaginal vault cytology is commonly used for follow-up surveillance in patients treated for cervical cancer. It is known that the smear inadequacy rate is high, especially in patients post-radiotherapy at 10%. The current practice is to use Cervex-Brush®, which was designed for cervical smear taking. Cervix will shrink into a dimple with a flat vaginal vault and vagina may be stenotic after radiotherapy, rendering the use of the conventional sampling device difficult. Orcellex® Brush was designed to collect cells from oral mucosa, with high patient satisfaction and low smear inadequacy of 1% in one study. As both the vaginal vault mucosa and oral mucosa are flat surface lined with stratified squamous epithelium, the use of Orcellex® Brush in vaginal vault smear appeared applicable. It has a smaller head with a flat surface of hair, which might better fit the flat vault surface and narrow vaginal canal. It is postulated that the Orcellex® Brush helps in improving vaginal vault smear adequacy rate in patients after radiotherapy treatment for cervical cancer.
Read the 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.
- Conditions
- Cervical Cancer
- Being tested
- Orcellex Brush, Cervex Brush
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orcellex BrushDevice
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.
Cervex BrushDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Cervex Brush | Placebo comparator | Not described Receives: Device: Orcellex Brush |
| Orcellex Brush | Active comparator | Not described Receives: Device: Cervex Brush |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vault cytology adequacy rate
Adequacy of vault smear sample was defined by the Bethesda System as a minimum of 2000 well-visualized and well-preserved squamous cells
Measured: through study completion, an average of 1 year
Secondary outcomes (4)
Patient pain score
Pain score 0-10 by visual analog scale higher score means higher level of pain minimum = 0 maximum = 10
Measured: through study completion, an average of 1 year
Vaginal bleeding
Any bleeding noted by investigators during per vaginal examination
Measured: through study completion, an average of 1 year
Detection of abnormal cytology
Any detection of abnormal cells by vault cytology
Measured: through study completion, an average of 1 year
borderline cellularity rate
borderline cellularity requiring further clarification
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2020
- Study start1 Jul 2020
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Princess Margaret Hospital, Hong Kong
- Sponsor type
- Other government
- Responsible party
- Principal investigator, He Mung Yuen, Princess Margaret Hospital, Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04461574
- Sponsor's protocol ID
- 147-06
- Status last verified
- Mar 2021
- First submitted
- 26 Jun 2020
- Last updated
- 17 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
So YL, He MY, Hui SK, Yu EL. Clinical trial comparing the use of Orcellex(R) Brush versus Cervex-Brush(R) on vaginal vault smear cytology adequacy rate in patients treated with radiotherapy for cervical cancer. J Gynecol Oncol. 2025 May;36(3):e43. doi: 10.3802/jgo.2025.36.e43. Epub 2024 Oct 22.
PubMed 39453394
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04461574
- Acronym / sponsor ID
- 147-06
- Conditions
- Cervical Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Princess Margaret Hospital, Hong KongOther government
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 8 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Vaginal vault cytology is commonly used for follow-up surveillance in patients treated for cervical cancer. It is known that the smear inadequacy rate is high, especially in patients post-radiotherapy at 10%. The current practice is to use Cervex-Brush®, which was designed for cervical smear taking. Cervix will shrink into a dimple with a flat vaginal vault and vagina may be stenotic after radiotherapy, rendering the use of the conventional sampling device difficult. Orcellex® Brush was designed to collect cells from oral mucosa, with high patient satisfaction and low smear inadequacy of 1% in one study. As both the vaginal vault mucosa and oral mucosa are flat surface lined with stratified squamous epithelium, the use of Orcellex® Brush in vaginal vault smear appeared applicable. It has a smaller head with a flat surface of hair, which might better fit the flat vault surface and narrow vaginal canal. It is postulated that the Orcellex® Brush helps in improving vaginal vault smear adequacy rate in patients after radiotherapy treatment for cervical cancer.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cervex Brush | Placebo comparator | Device: Orcellex Brush |
| Orcellex Brush | Active comparator | Device: Cervex Brush |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with cervical cancer treated with primary radiotherapy
- Patients aged 18 years or older
- Patients requiring vaginal vault cytology for follow-up surveillance
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Orcellex BrushSubjects 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. | Device | Cervex Brush |
| Cervex BrushSubjects 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. | Device | Orcellex Brush |
Primary outcome
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
4 secondary outcomes
Patient pain score
Time frame: through study completion, an average of 1 year
Vaginal bleeding
Time frame: through study completion, an average of 1 year
Detection of abnormal cytology
Time frame: through study completion, an average of 1 year
borderline cellularity rate
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2021.
- Derived from this study: PubMed 39453394So YL, He MY, Hui SK, Yu EL. Clinical trial comparing the use of Orcellex(R) Brush versus Cervex-Brush(R) on vaginal vault smear cytology adequacy rate in patients treated with radiotherapy for cervical cancer. J Gynecol Oncol. 2025 May;36(3):e43. doi: 10.3802/jgo.2025.36.e43. Epub 2024 Oct 22.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Orcellex Brush and Cervex Brush in people with Cervical Cancer, run by Princess Margaret Hospital, Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mung Yuen He, MBBS (85262403147, hmy703@ha.org.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vault cytology adequacy rate (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04461574, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2021.