The objective of this feasibility / pilot study is to clarify the clinical performance and economic efficiency of the cervical cancer screening system which is under development at Sysmex Corp Japan. In this study, the objective should be achieved…
ID
Source
Brief title
Condition
- Reproductive neoplasms female malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The histology results from the routine cytology positive sample will be
compared to the sensitivity of other tests (cytology, LC-1000 and HPV) (primary
evaluation criteria). To verify the clinical screening performance of the FCM
system (LC-1000), the cytology result of the routine cytology sample and the
LC-1000 result will be compared, sensitivity and specificity for advanced
cervical lesions (CIN2 lesions or higher stages) finally calculated (secondary
evaluation criteria).
Secondary outcome
none
Background summary
see below
Study objective
The objective of this feasibility / pilot study is to clarify the clinical
performance and economic efficiency of the cervical cancer screening system
which is under development at Sysmex Corp Japan. In this study, the objective
should be achieved by executing reliable tests with (1) strict operational
sampling, (2) well-managed use of the samples, (3) comparison with high-quality
cytology diagnosis, and (4) considering implementation to screening workflow
with clarifying its economic efficiency.
Study design
In this feasibility / pilot study, which will need the consent of the medical
ethics review board of the hospital, 500 women over 20 years of age who have
had cervical cytology tests, will be included. All women included in the study
need to have signed an informed consent document and then the algorithm set by
earlier pilot studies will be validated by comparing results from cytology /
histology, the FCM system (LC-1000) and HPV testing. This algorithm is
schematically shown in the protocol (page 5).
Study burden and risks
During the routine gynaecological survey, a second cervical smear will be taken
if a first smear is necessary for further diagnosis. Burden and additional
risks will be considered as minimal.
Bornbarch 1
Norderstedt 22848
DE
Bornbarch 1
Norderstedt 22848
DE
Listed location countries
Age
Inclusion criteria
females older than 20 years who visit a gynaecologist for a cervical smear
Exclusion criteria
females younger than 20 years, pregnant women, women who were deemed inappropriate by their gynecologist to participate in this study, and women who underwent cervical conisation* (or total hysterectomy). However, after a certain period (approx. 6 month) following cervical conisation, it*s possible to participate in this study at the discretion of the gynecologist.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL55793.096.15 |