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| Name | Class |
|---|---|
| University Hospital Pilsen | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RD-100i, OSNA | SLNM and OSNA assessment of sentinel lymph nodes compared to ultrastaging |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RD-100i, OSNA | Device | quantitative reverse transcription polymerase chain reaction (qRT-PCR) cytokeratin-19 detection in specimen (sentinel lymph node) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients older than 18 years diagnosed with endometrial cancer.
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| Name | Affiliation | Role |
|---|---|---|
| Ondřej Topolčan, Prof. MUDr. | Department of Nuclear Medicine, Medical School and Teaching Hospital in Pilsen, Charles University in Prague, Prague, Czech Republic | Study Chair |
| Zdeněk Novotný, Doc.MUDr. | Department of Obstetrics and Gynaecology, University Hospital in Pilsen, Charles University in Prague, Czech Republic | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty Hospital in Pilsen | Pilsen | 30460 | Czechia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25190122 | Background | 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. | |
| 21290195 |
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| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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Samples of the tissue homogenate will be retained and may be used for further testing.
| 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. |
| 23811115 | Background | 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. |
| 23533593 | Background | 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. |
| 11277658 | Background | 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. doi: 10.1006/gyno.2000.6111. |
| 26645990 | Background | Colombo N, Creutzberg C, Amant F, Bosse T, Gonzalez-Martin 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. |
| 23694985 | Background | 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. |
| 23321065 | Background | 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. |
| D014591 |
| Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |