Biomarker detection in cytololgy samples of women with gynaecological cancer: a multicentric study
Recruiting
- Conditions
- gynaecological cancergynaecological malignancy10038594
- Registration Number
- NL-OMON55675
- Lead Sponsor
- Vrije Universiteit Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 270
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
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
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Biomarker levels (for example methylation levels) in several cytology samples<br /><br>of participants/patients with endometrial or cervical cancer are the primary<br /><br>parameter in this study. The proportion of cytology samples with a positive<br /><br>test result will be measured in cancer cases (participants/patients with<br /><br>endometrial or cervical cancer). Sensitivity and specificity will be<br /><br>calculated. In de pilotstudie, the association between the testresult and teh<br /><br>outcome of the study will be studied (benign of malignant ovarian proces).</p><br>
- Secondary Outcome Measures
Name Time Method <p>Biomarker levels in diagnostic tumor material will be measured and related to<br /><br>levels found in cytology samples. </p><br>