NCT04461574

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 26, 2020

Completed
5 days until next milestone

Study Start

First participant enrolled

July 1, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 8, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

March 17, 2021

Status Verified

March 1, 2021

Enrollment Period

2 years

First QC Date

June 26, 2020

Last Update Submit

March 15, 2021

Conditions

Cervical Cancer

Outcome Measures

Primary Outcomes (1)

  • 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

    through study completion, an average of 1 year

Secondary Outcomes (4)

  • Patient pain score

    through study completion, an average of 1 year

  • Vaginal bleeding

    through study completion, an average of 1 year

  • Detection of abnormal cytology

    through study completion, an average of 1 year

  • borderline cellularity rate

    through study completion, an average of 1 year

Study Arms (2)

Cervex Brush

PLACEBO COMPARATOR
Device: Orcellex Brush

Orcellex Brush

ACTIVE COMPARATOR
Device: Cervex Brush

Interventions

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 Brush
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.

Orcellex Brush

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with cervical cancer treated with primary radiotherapy
  • Patients aged 18 years or older
  • Patients requiring vaginal vault cytology for follow-up surveillance

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Princess Margaret Hospital

Hong Kong, 000, Hong Kong

RECRUITING

Related Publications (1)

  • 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.

    PMID: 39453394DERIVED

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Central Study Contacts

Mung Yuen He, MBBS

CONTACT

85262403147hmy703@ha.org.hk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Consultant

Study Record Dates

First Submitted

June 26, 2020

First Posted

July 8, 2020

Study Start

July 1, 2020

Primary Completion

June 30, 2022

Study Completion

June 30, 2022

Last Updated

March 17, 2021

Record last verified: 2021-03

Locations

HK(1)