Endometrial CancerSLNM/OSNANCT02826291
SLNM in Endometrial Cancer Combined With OSNA
An observational study of Endometrial Cancer, run by Charles University, Czech Republic at 1 site in Czechia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Cancer
- What is being tested?
- RD-100i, OSNA
- Type of treatment
- Medical device
- How many people
- 58 participants
- Where
- 1 siteCzechia
- Study dates
- Mar 2016to 1 Feb 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients older than 18 years diagnosed with endometrial cancer.
Who may be able to join
- Endometrial cancer
- Signed informed consent
- Pregnant patients
- Patients participating in other clinical studies
- Patients who have been judged to be an inappropriate candidate by any medical care provider
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sentinel Lymph Node Mapping in Endometrial Cancer Patients Combined With One-step Nucleic Acid Amplification (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.
Read the detailed 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.
- Conditions
- Endometrial Cancer
- Being tested
- RD-100i, OSNA
- Keywords
- OSNA, sentinel, lymph, node, endometrial, cancer
- Medical subject headings
- Endometrial Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RD-100i, OSNADevice
quantitative reverse transcription polymerase chain reaction (qRT-PCR) cytokeratin-19 detection in specimen (sentinel lymph node)
| Study group | Role | What they receive |
|---|---|---|
| RD-100i, OSNA | SLNM and OSNA assessment of sentinel lymph nodes compared to ultrastaging Receives: Device: RD-100i, OSNA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2016 (estimated)
- Study startMar 2016
- Primary completion31 Jan 2018
- Study completion1 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- More trials run by Charles University, Czech RepublicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Pilsen
- Responsible party
- Principal investigator, Jan Kosťun, Charles University, Czech Republic
- Investigators
- Ondřej Topolčan, Prof. MUDr., Study chair, Department of Nuclear Medicine, Medical School and Teaching Hospital in Pilsen, Charles University in Prague, Prague, Czech RepublicZdeněk Novotný, Doc.MUDr., Study chair, Department of Obstetrics and Gynaecology, University Hospital in Pilsen, Charles University in Prague, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02826291
- Sponsor's protocol ID
- OSNA-EC-01
- Acronym
- SLNM/OSNA
- Status last verified
- Jul 2018
- First submitted
- 5 Jul 2016
- Last updated
- 18 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 25190122Yamamoto 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.
PubMed 21290195Okamoto 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.
PubMed 23811115Buglioni 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.
PubMed 23533593Mariani 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.
PubMed 11277658Colombo 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.
PubMed 26645990Kim 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.
PubMed 23694985Leitao 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.
PubMed 23321065
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sentinel Lymph Node Mapping in Endometrial Cancer Patients Combined With One-step Nucleic Acid Amplification (OSNA)
- ClinicalTrials.gov ID
- NCT02826291
- Acronym / sponsor ID
- SLNM/OSNA / OSNA-EC-01
- Conditions
- Endometrial Cancer
- Keywords
- OSNA, sentinel, lymph, node, endometrial, cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Collaborators
- University Hospital Pilsen
- Study start
- Mar 2016
- Primary completion
- 31 Jan 2018 (actual)
- Study completion
- 1 Feb 2018 (actual)
- First posted
- 7 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RD-100i, OSNA | – | Device: RD-100i, OSNASLNM and OSNA assessment of sentinel lymph nodes compared to ultrastaging |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients older than 18 years diagnosed with endometrial cancer.
Key inclusion criteria (5 listed)
- Endometrial cancer
- Signed informed consent
- Pregnant patients
- Patients participating in other clinical studies
- Patients who have been judged to be an inappropriate candidate by any medical care provider
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RD-100i, OSNAquantitative reverse transcription polymerase chain reaction (qRT-PCR) cytokeratin-19 detection in specimen (sentinel lymph node) | Device | RD-100i, OSNA |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2018.
- Background: PubMed 25190122Nagai 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.
- Background: PubMed 21290195Yamamoto 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.
- Background: PubMed 23811115Okamoto 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.
- Background: PubMed 23533593Buglioni 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.
- Background: PubMed 11277658Mariani 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.
- Background: PubMed 26645990Colombo 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.
- Background: PubMed 23694985Kim 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.
- Background: PubMed 23321065Leitao 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ondřej Topolčan, Prof. MUDr. study chair
Department of Nuclear Medicine, Medical School and Teaching Hospital in Pilsen, Charles University in Prague, Prague, Czech Republic
Zdeněk Novotný, Doc.MUDr. study chair
Department of Obstetrics and Gynaecology, University Hospital in Pilsen, Charles University in Prague, Czech Republic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometrial Cancer, run by Charles University, Czech Republic at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of CK 19 copies detected by OSNA (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02826291, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2018.