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SLNM in Endometrial Cancer Combined With OSNA

NCT02826291 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 58

Last updated 2018-07-18

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

RD-100i, OSNA

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

Sponsors & Collaborators

  • University Hospital Pilsen

    collaborator OTHER

  • Charles University, Czech Republic

    lead OTHER

Principal Investigators

  • Ondřej Topolčan, Prof. MUDr. · Department of Nuclear Medicine, Medical School and Teaching Hospital in Pilsen, Charles University in Prague, Prague, Czech Republic

  • Zdeněk Novotný, Doc.MUDr. · Department of Obstetrics and Gynaecology, University Hospital in Pilsen, Charles University in Prague, Czech Republic

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2018-01-31
Completion
2018-02-01

Countries

  • Czechia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02826291 on ClinicalTrials.gov