SLNM in Endometrial Cancer Combined With OSNA (SLNM/OSNA)

Charles University, Czech Republic

Status: Completed

Conditions: Endometrial Cancer

Treatments: Device: RD-100i, OSNA

Study type: Observational

Funder types: Other

Identifiers

NCT02826291

OSNA-EC-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 58 patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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

Trial design

58 participants in 1 patient group

RD-100i, OSNA

Description:

SLNM and OSNA assessment of sentinel lymph nodes compared to ultrastaging

Treatment:

Device: RD-100i, OSNA