Skip to main content
OpenTrials
Completed

NCT Number: NCT02826291

SLNM in Endometrial Cancer Combined With OSNA

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Endometrial Cancer Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Faculty Hospital in Pilsen

Pilsen, 30460, Czechia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RD-100i, OSNA

Device

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

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Charles University, Czech Republic

Other

Collaborators

  • University Hospital Pilsen

Registry information

Official study title

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

Acronym: SLNM/OSNA

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jul 7, 2016
Registry last updated
Jul 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.