Primary objective:To distinguish benign ovarium lesions from early cancer lesions, based upon their platelet RNA profile. Secondary objectives:* Evaluate the diagnostic accuracy of platelet RNA profiling in detecting early-stage ovarium cancer…
ID
Source
Brief title
Condition
- Reproductive neoplasms female malignant and unspecified
- Obstetric and gynaecological therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The difference in blood platelet RNA profile between ovarium cancer and benign
ovarium lesions.
Secondary outcome
none
Background summary
Cancer is primarily diagnosed by clinical presentation, imaging and pathological
analysis of tissue biopsies, increasingly supported by molecular diagnostics
tests. However,
late diagnosis and misdiagnosis due to limitations of tissue biopsy acquisition
remains a major problem. Therefore, a general blood test to pinpoint cancer
early and adequately can be considered the *Holy Grail*, because diagnosis in
an earlier stage significantly improves the chance of cure from cancer. Several
blood-based biosources are currently being evaluated as liquid biopsies,
including cell-free DNA and circulating tumor cells, but none of these have
been implemented for primary (multiclass) cancer diagnostics. Tumor-educated
platelets (TEPs) can function as potential blood-based biosource for (early)
cancer diagnostics. Blood platelets - the second most-abundant cell type in our
blood - are implicated in hemostasis and wound healing. Platelets have recently
emerged as central players and immediate responders in the systemic and local
responses to tumor growth. Confrontation of platelets by tumor cells via
transfer of tumor-associated biomolecules (*education*) results in the
sequestration of these biomolecules (derived from both tumor and its
micro-environment), causing a distinct platelet mRNA profile. We have
previously shown that platelets acquire glioblastoma and prostate cancer mRNA
biomarkers and that glioblastoma TEP mRNA profiles harbour diagnostic
potential.
Study objective
Primary objective:
To distinguish benign ovarium lesions from early cancer lesions, based upon
their platelet RNA profile.
Secondary objectives:
* Evaluate the diagnostic accuracy of platelet RNA profiling in detecting
early-stage ovarium cancer compared to healthy controls;
* Evaluate the diagnostic accuracy of platelet RNA profiling in detecting
early-stage ovarium cancer compared to stage IV ovarium cancer;
* Evaluate the accuracy of platelet RNA profiling in differentiating between
ovarium cancer and other tumor types.
Study design
Observational study (cohort)
Study burden and risks
None
Albinusdreef 2
Leiden 2333ZA
NL
Albinusdreef 2
Leiden 2333ZA
NL
Listed location countries
Age
Inclusion criteria
Surgery becasuse of ovarian mass and/or surgery becasue of suspician of ovarian
cancer
Exclusion criteria
Suffering from other malignancies than ovariancancer
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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 | NL58161.058.16 |