Protocol for Cervical Cancer Screening FCM Feasibility Study in EU. Measurement of the cell proliferation status / detection of cervical lesions for rapid screening (high throughput) of Cervical Cancer with the LC-1000

Protocol for Cervical Cancer Screening FCM Feasibility Study in EU. Measurement of the cell proliferation status / detection of cervical lesions for rapid screening (high throughput) of Cervical Cancer with the LC-1000 - Protocol for Cervical Cancer Screening FCM Feasibility Study in EU.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON43409

Enrollment

500

Registered

2016-02-18

Start date

2016-02-18

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cervical cancer

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: females older than 20 years who visit a gynaecologist for a cervical smear

Exclusion criteria

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 outcomes

Primary

Measure	Time frame
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).	—

Measure

Time frame

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

Measure	Time frame
none	—

Countries

Netherlands

Outcome results