SLNM in Endometrial Cancer Combined With OSNA

Endometrial Cancer Clinical Trial

— SLNM/OSNA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02826291
• Other study ID #: OSNA-EC-01
• Status: Completed
• Start date: March 2016
• Est. completion date: February 1, 2018

Study information

• Verified date: July 2018
• Source: Charles University, Czech Republic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: February 1, 2018
• Est. primary completion date: January 31, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Endometrial Cancer
• Endometrial Neoplasms

Intervention

Device:
• RD-100i, OSNA
quantitative reverse transcription polymerase chain reaction (qRT-PCR) cytokeratin-19 detection in specimen (sentinel lymph node)

Locations

Country	Name	City	State
Czechia	Faculty Hospital in Pilsen	Pilsen

Sponsors (2)

Lead Sponsor	Collaborator
Charles University, Czech Republic	University Hospital Pilsen

Country where clinical trial is conducted

Czechia, 

References & Publications (8)

Buglioni S, Di Filippo F, Terrenato I, Casini B, Gallo E, Marandino F, Maini CL, Pasqualoni R, Botti C, Di Filippo S, Pescarmona E, Mottolese M. Quantitative molecular analysis of sentinel lymph node may be predictive of axillary node status in breast cancer classified by molecular subtypes. PLoS One. 2013;8(3):e58823. doi: 10.1371/journal.pone.0058823. Epub 2013 Mar 22. — View Citation

Colombo N, Creutzberg C, Amant F, Bosse T, González-Martín A, Ledermann J, Marth C, Nout R, Querleu D, Mirza MR, Sessa C; ESMO-ESGO-ESTRO Endometrial Consensus Conference Working Group. ESMO-ESGO-ESTRO Consensus Conference on Endometrial Cancer: Diagnosis, Treatment and Follow-up. Int J Gynecol Cancer. 2016 Jan;26(1):2-30. doi: 10.1097/IGC.0000000000000609. — View Citation

Kim CH, Soslow RA, Park KJ, Barber EL, Khoury-Collado F, Barlin JN, Sonoda Y, Hensley ML, Barakat RR, Abu-Rustum NR. Pathologic ultrastaging improves micrometastasis detection in sentinel lymph nodes during endometrial cancer staging. Int J Gynecol Cancer. 2013 Jun;23(5):964-70. doi: 10.1097/IGC.0b013e3182954da8. — View Citation

Leitao MM Jr, Khoury-Collado F, Gardner G, Sonoda Y, Brown CL, Alektiar KM, Hensley ML, Soslow RA, Barakat RR, Abu-Rustum NR. Impact of incorporating an algorithm that utilizes sentinel lymph node mapping during minimally invasive procedures on the detection of stage IIIC endometrial cancer. Gynecol Oncol. 2013 Apr;129(1):38-41. doi: 10.1016/j.ygyno.2013.01.002. Epub 2013 Jan 12. — View Citation

Mariani A, Webb MJ, Keeney GL, Podratz KC. Routes of lymphatic spread: a study of 112 consecutive patients with endometrial cancer. Gynecol Oncol. 2001 Apr;81(1):100-4. — View Citation

Nagai T, Niikura H, Okamoto S, Nakabayashi K, Matoda M, Utsunomiya H, Nagase S, Watanabe M, Takeshima N, Yaegashi N. A new diagnostic method for rapid detection of lymph node metastases using a one-step nucleic acid amplification (OSNA) assay in endometrial cancer. Ann Surg Oncol. 2015 Mar;22(3):980-6. doi: 10.1245/s10434-014-4038-2. Epub 2014 Sep 5. — View Citation

Okamoto S, Niikura H, Nakabayashi K, Hiyama K, Matoda M, Takeshima N, Watanabe M, Nagase S, Otsuki T, Yaegashi N. Detection of sentinel lymph node metastases in cervical cancer: assessment of KRT19 mRNA in the one-step nucleic acid amplification (OSNA) method. Gynecol Oncol. 2013 Sep;130(3):530-6. doi: 10.1016/j.ygyno.2013.06.027. Epub 2013 Jun 28. Erratum in: Gynecol Oncol. 2013 Dec;131(3):791. — View Citation

Yamamoto H, Sekimoto M, Oya M, Yamamoto N, Konishi F, Sasaki J, Yamada S, Taniyama K, Tominaga H, Tsujimoto M, Akamatsu H, Yanagisawa A, Sakakura C, Kato Y, Matsuura N. OSNA-based novel molecular testing for lymph node metastases in colorectal cancer patients: results from a multicenter clinical performance study in Japan. Ann Surg Oncol. 2011 Jul;18(7):1891-8. doi: 10.1245/s10434-010-1539-5. Epub 2011 Feb 3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of CK 19 copies detected by OSNA	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.	14 days