SLNM in Endometrial Cancer Combined With OSNA

Completed

• Conditions: Endometrial Cancer
• Interventions: Device: RD-100i, OSNA

• Registration Number: NCT02826291
• Lead Sponsor: Charles University, Czech Republic

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 Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-07-05
• Study First Submitted QC: 2016-07-06
• Study First Posted: 2016-07-07
• Primary Completion: 2018-01-31
• Study Completion: 2018-02-01
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-17
• Last Update Posted: 2018-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 58

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
RD-100i, OSNA	RD-100i, OSNA	SLNM and OSNA assessment of sentinel lymph nodes compared to ultrastaging

Primary Outcome Measures

Name	Time	Method
number of CK 19 copies detected by OSNA	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.

Trial Locations

Locations (1)

Faculty Hospital in Pilsen; 🇨🇿 Pilsen, Czechia