This study consists of two phases. For more information about the study layout, see page 13-16 of the research protcol.The aim of phase 2:- To compare two different sentinel node techniques in patients, suspicious for endometrial cancer. The main…
ID
Source
Brief title
Condition
- Reproductive neoplasms female malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
PRIMARY OUTCOME PHASE 1
Which technique is most accurate and/or feasible, when being used as a method
mapping the lymph node drainage routes and sentinel nodes of the uterus?
The two different techniques and drainage patterns will be compared to one and
other. The main points of interest will be:
- feasibility
- patient friendliness
- the location of the sentinel nodes (pelvic and/or para-aortal)
- the level of para-aortal drainage (high and/or low)
PRIMARY OUTCOME PHASE 2
- The number of sentinel nodes found after injection with Technetium 99m
labelled nanocolloid and blue (= detection rate)
- The reliability of the sentinel node procedure in high risk endometrial
cancer, which will be determined by the false negative rate after histological
examination of all removed nodes using the *gold standard* (= multiple
sectioning and hematoxylin and eosin staining)
- The feasibility and reliability of the OSNA CK 19 test as an in
intraoperative method to diagnose lymph node macro- and micrometastasis in
sentinel nodes of high risk endometrial cancer. Histopathological examination
(H&E) will be used as control method. In case of discordant cases
immunohistochemistry will be used as reference method. The reliability will be
defined by the true histological false negative rate.
Secondary outcome
SECONDARY OUTCOME PHASE 2
- Percentage of macro- and micrometastasis per lymph node station
- Number of nodes removed by laparotomic versus laparoscopic staging
- 5-Year recurrence free survival (RFS), disease specific (DSS) and overall
survival (OS) of sentinel node negative versus sentinel node positive patients
with high risk endometrial cancer (mainly those with micrometastasis)
Background summary
Endometrial cancer is the most frequent gynaecological cancer in industrialized
countries. The disease has a relatively good prognosis. Those patients who die
of the disease, die of distant metastases and recurrent disease.
Histological differentiation grade, tumour type and the depth of myometrial
involvement, and - after surgery - lymph node involvement are the main
prognostic factors in endometrial cancer.
Treatment of early stage endometrial cancer consists of surgical removal of the
uterus and adnexa, peritoneal cytology and lymph node assessment.
Current non-invasive imaging techniques are restricted in their ability to
detect metastatic lymph node spread. On the other hand, the benefits of
invasive surgery like a complete lymphadenectomy as part of the routine staging
procedure (abdominal hysterectomy and BSO) remain controversial.
Both supporters and opponents of a routine lymphadenectomy agree that a pre- or
peroperative non-invasive test to detect lymph node metastases would be
valuable. Until now, only macroscopic nodal metastases can be visualized.
Detailed pathological study of a lymph node with ultrastaging and
immunohistochemical or PCR analysis can identify lymph node micrometastases
that conventional methods would identify as negative for metastatic disease.
Surgical techniques have been developed to identify and sample lymph nodes that
can subsequently be submitted to such tests. It would therefore be timely to
investigate such approaches also in endometrial cancer.
Study objective
This study consists of two phases. For more information about the study layout,
see page 13-16 of the research protcol.
The aim of phase 2:
- To compare two different sentinel node techniques in patients,
suspicious for endometrial cancer. The main points of interest will be:
feasibility and patient friendlyness and the image on
lymphoscintigraphy
- Mapping the lymphatic drainage system of the uterus
The aim of phase 2:
- To investigate the reliability of the sentinel node procedure in patients
with high risk endometrial cancer
- Identification of nodes, in terms of prevalence and location, for subsequent
ultrastaging
- Identify micrometases using a new peroperative *one step nucleic acid
amplification* (OSNA, by SYSMEX) method
- Correlate results of presence and location of micrometastases with time to
recurrence and survival.
Study design
Study lay-out phase 1 and 2: research protocol page 13-16
See also the schematic overview on page 25 and 26.
Study burden and risks
See answer question E9
Veembroederhof 185
1019HD Amsterdam
Nederland
Veembroederhof 185
1019HD Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
The studie consists of two phases.
- Inclusion criteria for phase 1:
All women, suspicious for endometrial cancer, undergoing hysteroscopy and hysterectomy.
- Inclusion criteria for phase 2:
All women with high risk endometrial cancer, meaning that patients meet at least one of the following criteria:
> 50% myometrial invasion
differentiation grade 3
clearcell or serous papillary histology
carcinosarcoma
suspicious for extra-corporal spead
Exclusion criteria
Patients with contraindications for open abdominal or laparoscopic surgery will be excluded: cervical or pelvic infection, severe cardio-pulmonal or other co-morbidity contra-indicating extensive surgery and anaesthesia.
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 | NL32601.100.10 |