The purpose of this study is to investigate the characteristics of different sub cellular constituents in different body fluids of patients with advanced EOC with different histotypes. Besides obtaining more clarity about the role of these…
ID
Source
Brief title
Condition
- Reproductive neoplasms female malignant and unspecified
- Ovarian and fallopian tube disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
In this protocol, various parameters are to be distinguished:
- Differences in concentration of ctDNA copy numbers and specific DNA fragments
in EOC, EOC responding adequately to chemotherapy and EOC with chemotherapy
resistance.
- Differences in concentration of miRNA and specific miRNAs in EOC, EOC
responding adequately to chemotherapy and EOC with chemotherapy resistance.
- Differences in concentration and characteristics of EVs from patients with
EOC, EOC responding adequately to chemotherapy and EOC with chemotherapy
resistance.
Secondary outcome
Not applicable.
Background summary
Standard care for advanced epithelial ovarian carcinoma (EOC) comprises
cytoreductive surgery in combination with platinum and taxane based
chemotherapy. Although initially, chemotherapy yields response rates of more
than 80%, platinum-resistance is frequently seen in recurrent disease,
especially in patients with recurrence within 6 months after initial treatment.
Prediction of chemosensitivity could prevent unnecessary harmful treatment,
with accompanying side-effects. Recent years, the importance of the influence
of tumour derived subcellular particles, like circulating tumour DNA (ctDNA),
microRNA (miRNA) and extracellular vesicles (EVs), on chemotherapy resistance
has been increasingly recognised. Knowledge of these subcellular particles is a
prerequisite for understanding tumour behaviour during treatment and
progression.
Study objective
The purpose of this study is to investigate the characteristics of different
sub cellular constituents in different body fluids of patients with advanced
EOC with different histotypes. Besides obtaining more clarity about the role of
these subcellular particles in chemoresistance, we attempt to identify new
biomarkers for early detection of drug resistance.
Study design
Following informed consent, plasma and urine, and if possible ascites, will be
collected during presentation and follow-up in the outpatient clinic. ctDNA,
miRNA and EVs will be labeled and analysed by flowcytometry, TEM, Tam-Seq,
Taqman miRNA assays and PCR analysis.
Study burden and risks
Not applicable.
Plesmanlaan 121
Amsterdam 1066CX
NL
Plesmanlaan 121
Amsterdam 1066CX
NL
Listed location countries
Age
Inclusion criteria
Patients with untreated epithelial ovarian cancer, stage III or IV.
Exclusion criteria
Patients deprived from ability to decide for participation on her own
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 | NL50907.031.14 |