SLNM in Endometrial Cancer Combined With OSNA

Sentinel Lymph Node Mapping in Endometrial Cancer Patients Combined With One-step Nucleic Acid Amplification (OSNA)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02826291

Acronym

SLNM/OSNA

Enrollment

Registered

2016-07-07

Start date

2016-03-31

Completion date

2018-02-01

Last updated

2018-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometrial Cancer

Keywords

OSNA, sentinel, lymph, node, 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.

Interventions

DEVICERD-100i, OSNA

quantitative reverse transcription polymerase chain reaction (qRT-PCR) cytokeratin-19 detection in specimen (sentinel lymph node)

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Czechia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026