Objective: The aim of this study is to investigate the potential role of microvesicles as novel biomarkers for ovarian cancer and to asses if their presence and characteristics are related to stage and prognosis.
ID
Source
Brief title
Condition
- Reproductive neoplasms female malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
This project concerns the relevance of vesicles in ovarian cancer as potential
biomarkers and can be subdivided in the following research sections:
1) Microparticles and exosomes will be isolated from urine, ascites and blood
and identified on basis of their size, density and ability to bind cell
specific antibodies. This will be measured by the use of a flow cytometer.
Microvesicles presence and characteristics will be analysed and compared with
those of healthy volunteers.
2) The presence of different proteins will be analysed within the isolated
microvesicles and in the remaining supernatant. Different immunostaining
techniques will be applied, such as western blots, flow cytometer and ELISpot.
We will compare protein expression pattern from vesicles from patients with
ovarian cancer and healthy volunteers to explore the sensitivity (and
specificity) of the potential markers.
Secondary outcome
3) Depending on these results, collected samples may be used to investigate
genetic material which is captured in the microvesicles. Specific RNA sequences
within isolated microparticles or exosomes will be analysed by use of reverse
transcription polymerase chain reactions (RT-PCR). Other methods such as
micro-arrays may be used to further investigate microvesicle*s RNA and DNA.
Background summary
Rationale: Ovarian cancer is the sixth most common cancer affecting females and
it is the most common cause of gynaecologic cancer- associated death. Advances
in imaging techniques, surgical management, radiotherapy and chemotherapy have
improved the outcome for patients. However for ovarian cancer, as for the most
gynaecological cancers, the understanding of the cause and course at cellular
level is incomplete. A possible relevant cellular mechanism is the formation of
microvesicles such as microparticles (MP) and exosomes. Growing evidence
suggests that vesicles released from cancer cells in gynaecological
malignancies contribute to malignant behaviour. Moreover, tumour cell-derived
exosomes have been suggested as diagnostic biomarkers. This study investigates
the potential role of microvesicles in plasma, urine and ascites as novel
biomarkers for ovarian cancer and asses if their presence and characteristics
are related to disease stage and prognosis.
Study objective
Objective: The aim of this study is to investigate the potential role of
microvesicles as novel biomarkers for ovarian cancer and to asses if their
presence and characteristics are related to stage and prognosis.
Study design
Study design: This is an exploratory pilot study.
Study burden and risks
This study involves the use of blood samples, collection of a urine sample and
collection of ascites. To minimize burden the taking of blood samples during
this study will be combined with the routine investigations. One sample of
midstream urine (small sterile container; 30ml) will be collected from each
patient or healthy volunteer. Ascites fluid will only be collected when a
ascites tap is performed for diagnostic purposes or symptom relieve. The
majority of the fluid will be discarded. A small sample of this material will
be used for research. There are no direct benefits for participating subjects.
De Boelelaan 1117 kamernummer: 8F 22
Amsterdam 1081HV
NL
De Boelelaan 1117 kamernummer: 8F 22
Amsterdam 1081HV
NL
Listed location countries
Age
Inclusion criteria
Material from 30 patients diagnosed with ovarian cancer and samples from 30 healthy volunteers will be collected. ;Inclusion criteria for the two groups;1. Patients with ovarian cancer: ;a. Diagnosed with epithelial ovarian cancer
b. > 18 years
c. Treatment in VUMC
d. Understanding of the Dutch or English language
e. Not using any medication
f. No thrombotic events in history
g. Written informed consent ;2. Healthy volunteers: ;a. > 18 years
b. Understanding of the Dutch or English language
c. Not using any medication
d. No malignancies in past
e. No thrombotic events in history
f. Written informed consent
Exclusion criteria
1. Patients with ovarian cancer: ;a. < 18 years
b. No understanding of the Dutch or English language
c. Patients with history of malignancy other than that of ovarian cancer
d. Use of medication
e. Thrombotic events in history
f. No written informed consent ;2. Healthy volunteers: ;a. < 18 years
b. No understanding of the Dutch or English language
c. Use of medication
d. Malignancies in past
e. Thrombotic events in history
f. No written informed consent
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 | NL38580.029.12 |