Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for all trials

Timeline

Completed

Started Mar 2016

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.9 years study duration

Study Start

First participant enrolled

March 1, 2016

Completed

4 months until next milestone

First Submitted

Initial submission to the registry

July 5, 2016

Completed

2 days until next milestone

First Posted

Study publicly available on registry

July 7, 2016

Completed

1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2018

Completed

1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed

Last Updated

July 18, 2018

Status Verified

July 1, 2018

Enrollment Period

1.9 years

First QC Date

July 5, 2016

Last Update Submit

July 17, 2018

Conditions

Endometrial Cancer

Keywords

OSNAsentinellymphnodeendometrialcancer

Outcome Measures

Primary Outcomes (1)

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

Study Arms (1)

RD-100i, OSNA

SLNM and OSNA assessment of sentinel lymph nodes compared to ultrastaging

Device: RD-100i, OSNA

Interventions

RD-100i, OSNADEVICE

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

RD-100i, OSNA

Eligibility Criteria

Age18 Years+

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodProbability Sample

Study Population

Patients older than 18 years diagnosed with endometrial cancer.

You may qualify if:

Endometrial cancer
Signed informed consent

You may not qualify if:

Pregnant patients
Patients participating in other clinical studies
Patients who have been judged to be an inappropriate candidate by any medical care provider

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Charles University, Czech Republiclead
University Hospital Pilsencollaborator

Study Sites (1)

Faculty Hospital in Pilsen

Pilsen, 30460, Czechia

Location

Related Publications (8)

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.
PMID: 25190122BACKGROUND
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.
PMID: 21290195BACKGROUND
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.
PMID: 23811115BACKGROUND
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.
PMID: 23533593BACKGROUND
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.
PMID: 11277658BACKGROUND
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.
PMID: 26645990BACKGROUND
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.
PMID: 23694985BACKGROUND
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.
PMID: 23321065BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Samples of the tissue homogenate will be retained and may be used for further testing.

MeSH Terms

Conditions

Endometrial NeoplasmsNeoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

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

Study Design

Study Type: observational
Observational Model: CASE ONLY
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: MUDr.

Study Record Dates

First Submitted

July 5, 2016

First Posted

July 7, 2016

Study Start

March 1, 2016

Primary Completion

January 31, 2018

Study Completion

February 1, 2018

Last Updated

July 18, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing: Will not share

Locations

CZ(1)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

RD-100i, OSNA

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (8)

Biospecimen

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Data Sharing

Locations