Sentinel Lymph Node Mapping in Endometrial Cancer Patients Combined With One-step Nucleic Acid Amplification (OSNA)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Endometrial Cancer
- Sponsor
- Charles University, Czech Republic
- Enrollment
- 58
- Locations
- 1
- Primary Endpoint
- number of CK 19 copies detected by OSNA
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
Jan Kosťun
MUDr.
Charles University, Czech Republic
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
Outcomes
Primary Outcomes
number of CK 19 copies detected by OSNA
Time Frame: 14 days
Number of CK 19 copies will be assessed: 250-5000 micrometastasis, more than 5000 copies macrometastasis. This result will be compared to histological ultrastaging examination.