To study the value of molecular biomarkers in cytology samples (cervical scrape, vaginal sample and urine) for cancer detection in patients with gynaecologic cancer.
ID
Source
Brief title
Condition
- Reproductive neoplasms female malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
Biomarker levels in diagnostic tumor material will be measured and related to
levels found in cytology samples.
Background summary
Studies have shown that testing for molecular biomarkers (such as methylation
markers and miRNAs) in cytology samples (including cervical scrapes, vaginal
samples and urine) can be useful to detect underlying endometrial or cervical
disease. Therefore, the new screening programme for cervical cancer (starting
early 2017) has the potential to be more effective when, beside (pre) malignant
cervical disease, other gynaecologic diseases, like endometrial cancer could be
detected as well. Early detection of cancer will lead to better outcome in
cancer patients. The pilot study in patients with and ovarian neoplasm is set
up to see if is is possible to better predict the nature of the ovarian
neoplasm (benign of malignant) which is important for monitoring and type of
surgery.
Study objective
To study the value of molecular biomarkers in cytology samples (cervical
scrape, vaginal sample and urine) for cancer detection in patients with
gynaecologic cancer.
Study design
Prospective multicentre cross-sectional study
Study burden and risks
In this study, health risks associated with procedures to collect the different
cytology samples (ie cervical scrape, vaginal sample and urine) can be
considered negligible. The physical burden is considered minimal as collection
of cytology samples will be without or with minimal discomfort. No pain is
expected to be related to the collection of vaginal and urine samples. Women
can experience an unpleasant sensation for a few seconds during sampling of the
cervical scrape. It should be noted that the cervical scrape will be taken
during a regularly planned gynaecologic examination. No extra gynaecologic
examination is needed for this study. When the cervical scrape is planned
during the operation, there will be no extra discomfort. By combining the high
numbers of potential study participants treated at the gynaecology departments
of CGOA and availability of tumour tissues at pathology departments with
professional collaborations between academic gynaecologists, pathologists,
molecular biologists and biostatisticians that have extensive experience on
doing clinical and translational research, the basis of a successful setting
for this study is consolidated. This study will neither interfere with the
regular clinical care, nor with the cancer treatment, nor with the outcome of
the cancer.
de Boelelaan 1117
Amsterdam 1081 HV
NL
de Boelelaan 1117
Amsterdam 1081 HV
NL
Listed location countries
Age
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
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 | NL56664.029.16 |