Clinical trial NCT02826291: 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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endometrial Cancer
Keywords: OSNA
sentinel
lymph
node
endometrial
cancer
Lead sponsor: Charles University, Czech Republic
Sponsor class: OTHER
Collaborators: name: University Hospital Pilsen
First posted: 2016-07-07
Enrollment: 58
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients older than 18 years diagnosed with endometrial cancer.

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.

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

Primary outcomes:
measure: number of CK 19 copies detected by OSNA
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Pilsen
country: Czechia
facility: Faculty Hospital in Pilsen
Study officials:
affiliation: Department of Nuclear Medicine, Medical School and Teaching Hospital in Pilsen, Charles University in Prague, Prague, Czech Republic
name: Ondřej Topolčan, Prof. MUDr.
role: STUDY_CHAIR
affiliation: Department of Obstetrics and Gynaecology, University Hospital in Pilsen, Charles University in Prague, Czech Republic
name: Zdeněk Novotný, Doc.MUDr.
role: STUDY_CHAIR
References:
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