The aim of this study is to investigate the structure and the biological behaviour of the peritoneum, in relation to the specific growth of EOC on the peritoneum, in order to identify the component of the peritoneum that maintains the blood-belly-…
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
1. Structural investigation of the peritoneum by histology and immunostaining
of peritoneal components in EOC.
2. Investigation of the peritoneal micro-environment in EOC, by measurement of
the quantity and characteristics of MPs and exosomes, excreted by mesothelial
cells, and by measurement of cytokines with anti-angiogenic or proliferation
inhibiting functions.
Secondary outcome
Not applicable
Background summary
Ovarian cancer is the most lethal gynaecologic cancer. Epithelial ovarian
cancer (EOC) spreads through the abdominal cavity, with involvement of the
peritoneum. Although this peritoneum of the abdominal wall is only a thin
serous membrane, peritoneal tumour depositions are generally small and growth
is superficial. Tumour growth through the peritoneum and invasion of the
abdominal wall is rare. Furthermore, EOC often stays in the abdominal cavity.
The specific intra-abdominal spreading pattern of EOC suggests a possible
barrier function of the peritoneum against tumour invasion and expansion across
the peritoneum. However, a full understanding of this barrier function in
relation to EOC at structural and (sub)cellular level remains to be clarified.
The role of the micro-environment of the peritoneum and the role of peritoneal
cell-derived particles in ascites or plasma, such as microparticles (MPs) and
exosomes, is largely unknown.
Study objective
The aim of this study is to investigate the structure and the biological
behaviour of the peritoneum, in relation to the specific growth of EOC on the
peritoneum, in order to identify the component of the peritoneum that maintains
the blood-belly-barrier.
Study design
Following informed consent, samples of peritoneum, plasma and ascites will be
collected during cytoreductive surgery or exploratory laparotomy Haematoxylin
and eosin staining and Elastica van Gieson staining will be carried out to
identify structural components of the peritoneum. Micro-environmental
components including MPs, exosomes and cytokines with anti-angiogenic or
proliferation inhibiting functions are determined by flowcytometry,
Transmission Electron Microscopy and Multiplex Immuno Analysis.
Intervention
During the planned surgery (regular treatment) a maximum of four samples of
peritoneum (4mm2 each) will be collected. Two peritoneal samples will contain
tumormaterial and two samples of peritoneum are macroscopic healthy. In
addition, one tube of blood will be taken from an already placed infusion
during surgery, and these two tubes will be ascites fluid collected from the
abdominal fluid aspirated. All the patients material will be collected once
during the scheduled surgery.
Study burden and risks
Not applicable
Plesmanlaan 121
Amsterdam 1066CX
NL
Plesmanlaan 121
Amsterdam 1066CX
NL
Listed location countries
Age
Inclusion criteria
1. Patients with serous ovarian cancer, FIGO stage III or IV, undergoing cytoreductive surgery or,
2. Patients undergoing abdominal surgery for a benign ovarian mass (control group)
Exclusion criteria
Patients deprived from ability to decide for participation on her own
During surgery, it appears, collection of samples is associated with additional health risk
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 | NL51422.031.14 |