Orcellex® Brush Versus Cervex-Brush® on Vault Smear Adequacy in Patients Treated With Radiotherapy for Cervical Cancer

NCT04461574UNKNOWNNAINTERVENTIONAL

Summary

Key Facts

Lead Sponsor

Princess Margaret Hospital, Hong Kong

Enrollment

160

Start Date

2020-07-01

Completion Date

2022-06-30

Study Type

INTERVENTIONAL

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

Interventions

Orcellex BrushCervex Brush

Conditions

Cervical Cancer

Eligibility

Age Range

18 Years+

Sex

FEMALE

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.

Outcome Measures

Primary Outcomes

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

Time frame: through study completion, an average of 1 year

Secondary Outcomes

Patient pain score

Pain score 0-10 by visual analog scale higher score means higher level of pain minimum = 0 maximum = 10

Time frame: through study completion, an average of 1 year

Vaginal bleeding

Any bleeding noted by investigators during per vaginal examination

Time frame: through study completion, an average of 1 year

Detection of abnormal cytology

Any detection of abnormal cells by vault cytology

Time frame: through study completion, an average of 1 year

borderline cellularity rate

borderline cellularity requiring further clarification

Time frame: through study completion, an average of 1 year

Locations

Princess Margaret Hospital, Hong Kong, Hong Kong

Orcellex® Brush Versus Cervex-Brush® on Vault Smear Adequacy in Patients Treated With Radiotherapy for Cervical Cancer