Brief Title
SLNM in Endometrial Cancer Combined With OSNA
Official Title
Sentinel Lymph Node Mapping in Endometrial Cancer Patients Combined With One-step Nucleic Acid Amplification (OSNA)
Brief Summary
The aim of the study is to compare one-step nucleic acid amplification method (OSNA) with
histological ultrastaging examination in the sentinel lymph node assessment in patients with
endometrial cancer.
The molecular biologic method OSNA is a modern way of metastatic spread detection in
lymphatic nodes using quantitative reverse transcription polymerase chain reaction.
Cytokeratin 19 (CK 19) was selected based on previous studies as the optimal mRNA marker
(detected by OSNA).
The intraoperative identification and rapid assessment of sentinel lymph nodes by OSNA could
help to improve the standards of care in endometrial cancer patients.
Detailed Description
Method:
After the sentinel lymph node detection (ICG, 99m Tc or Bleu Patente) and sentinel node/nodes
removal is performed, the node/nodes is/are cut in 2-mm slices parallel to short axis of the
node. The odd-numbered blocks will be examined by the OSNA method and the even-numbered
blocks will be examined by conventional histopathological methods including
immunohistochemistry.
Statistical analysis to identify differences will be performed subsequently.
Study Type
Observational
Primary Outcome
number of CK 19 copies detected by OSNA
Condition
Endometrial Cancer
Intervention
RD-100i, OSNA
Study Arms / Comparison Groups
RD-100i, OSNA
Description: SLNM and OSNA assessment of sentinel lymph nodes compared to ultrastaging
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
58
Start Date
March 2016
Completion Date
February 1, 2018
Primary Completion Date
January 31, 2018
Eligibility Criteria
Inclusion Criteria:
- Endometrial cancer
- Signed informed consent
Exclusion Criteria:
- Inclusion criteria not met
- Pregnant patients
- Patients participating in other clinical studies
- Patients who have been judged to be an inappropriate candidate by any medical care
provider
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Ondřej Topolčan, Prof. MUDr., ,
Location Countries
Czechia
Location Countries
Czechia
Administrative Informations
NCT ID
NCT02826291
Organization ID
OSNA-EC-01
Responsible Party
Principal Investigator
Study Sponsor
Charles University, Czech Republic
Collaborators
University Hospital Pilsen
Study Sponsor
Ondřej Topolčan, Prof. MUDr., Study Chair, Department of Nuclear Medicine, Medical School and Teaching Hospital in Pilsen, Charles University in Prague, Prague, Czech Republic
Verification Date
July 2018