Biomarker detection in cytololgy samples of women with gynaecological cancer: a multicentric study

Biomarker detection in cytololgy samples of women with gynaecological cancer: a multicentric study - Biomarker detection in cytololgy of women with gynaecological cancer

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON55675

Enrollment

270

Registered

2016-07-04

Start date

2016-10-11

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

gynaecological cancer gynaecological malignancy

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1) presence of endometrial or cervical cancer or, for the pilot study, planned surgery for an ovarian neoplasm 2) (expected) availability of diagnostic material of the tumor (histology tissue in referal or refered hospital) 3) possibility to collect cytology (cervical swab, vaginal sample and/or urine) prior to cancer treatment or surgery. 4) age 18 years or older

Exclusion criteria

Exclusion criteria: 1) No primary endometrial or cervical cancer or, for the pilot study, no planned sugery for an ovarian neoplasm 2) No (residual) tumour at time of inclusion 3) No possibility to collect cytology samples prior to cancer treatment 4) Age younger than 18 years

Design outcomes

Primary

Measure	Time frame
Biomarker levels (for example methylation levels) in several cytology samples of participants/patients with endometrial or cervical cancer are the primary parameter in this study. The proportion of cytology samples with a positive test result will be measured in cancer cases (participants/patients with endometrial or cervical cancer). Sensitivity and specificity will be calculated. In de pilotstudie, the association between the testresult and teh outcome of the study will be studied (benign of malignant ovarian proces).	—

Measure

Time frame

Biomarker levels (for example methylation levels) in several cytology samples of participants/patients with endometrial or cervical cancer are the primary parameter in this study. The proportion of cytology samples with a positive test result will be measured in cancer cases (participants/patients with endometrial or cervical cancer). Sensitivity and specificity will be calculated. In de pilotstudie, the association between the testresult and teh outcome of the study will be studied (benign of malignant ovarian proces).

—

Secondary

Measure	Time frame
Biomarker levels in diagnostic tumor material will be measured and related to levels found in cytology samples.	—

Countries

Netherlands

Outcome results