Endometrial CancerTRSGOSLN003NCT04560491
Intraoperative Examination of Sentinel Node in Endometrial Cancer (TRSGO-SLN-003)
An observational study of Endometrial Cancer and Sentinel Lymph Node, run by Ankara University at 1 site in Turkey (Türkiye).
Trial summary
More than half of the cases with macrometastatic sentinel lymph node (SLN) have non-SLN metastasis and leaving these nodes in-situ may impair the survival. This study assessed the diagnostic accuracy of intraoperative SLN frozen section examination and scrape cytology as a possible solution for management of SLN… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Cancer, Sentinel Lymph Node
- What is being tested?
- Intraoperative examination of sentinel node
- How many people
- 208 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2016to 30 Jun 2020
- 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 with clinical early stage endometrial cancer and underwent sentinel lymph node biopsy with intraoperative examination of sentinel node by either frozen section or scrape cytology.
Who may be able to join
- Patients with apparently early stage endometrial cancer whose SLNs were evaluated intraoperatively were included to this study
Who cannot join
- Patients with gross metastatic disease
- Patients who had contraindications to dyes (iodine allergy or hepatic impairments)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intraoperative Examination of Sentinel Node for The Decision of Further Lymphadenectomy in Clinical Early Stage Endometrial Cancer: A Diagnostic Study of Turkish Gynecologic Oncology Group (TRSGO-SLN-003)
More than half of the cases with macrometastatic sentinel lymph node (SLN) have non-SLN metastasis and leaving these nodes in-situ may impair the survival. This study assessed the diagnostic accuracy of intraoperative SLN frozen section examination and scrape cytology as a possible solution for management of SLN positive patients. Clinical early stage endometrial cancer patients who underwent SLN algorithm and intraoperative frozen section or scrape cytology to evaluate SLN status for metastasis were analyzed retrospectively. Intraoperative examination findings were compared with final pathology results and diagnostic accuracy of frozen section and scrape cytology were evaluated.
Read the detailed description
Frozen section: Lymph nodes up to 2 mm were embedded as a whole. Lymph nodes between 2-5 mm were cut in half along their long axis and nodes larger than 5 mm were sliced in neat, parallel slices at 2-3 mm intervals-slicing was perpendicular to the long axis of the node. Then whole of the SLNs were stained with hematoxylin and eosin (H\&E) and examined by frozen section.
Scrape Cytology: SLNs were cut into 3-mm-thick pieces along their long axis. If the lymph node was smaller than 3 mm, it was cut in half. Both sides of the pieces were scraped separately by an edge of a glass slide or a lancet gently. Obtained materials were smeared immediately onto a slide and placed in ethanol for fixation. Then, all slides were stained with H\&E and examined.
The results were reported to the surgeon as positive (metastatic) or negative with the numbers of lymph nodes. After intraoperative examination, lymph nodes were put into formalin solution and sent for final pathologic examination.
Data analyses were performed using SPSS Version 21.0 (IBM Corporation, Armonk, NYC, USA). Shapiro-Wilk test was performed to determine whether the data were normally distributed. Descriptive statistics of continuous variables were compared between groups using Mann-Whitney U test. The Chi-square test or Fisher's exact test (when chi-square test assumptions do not hold due to low expected cell counts) were used to compare categorical variables between groups. Continuous variables were presented as median and min-max values, whereas categorical variables were presented as number and percentage. A p value of <0.05 was considered statistically significant. Performance of each protocol to predict treatment success was assessed using confidence intervals with respect to sensitivity, specificity, positive predictive value, and negative predictive value.
- Conditions
- Endometrial Cancer, Sentinel Lymph Node
- Being tested
- Intraoperative examination of sentinel node
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoperative examination of sentinel nodeDiagnostic test
Intraoperative examination of sentinel node by either frozen section or scrape cytology to detect metastasis and decide for further lymphadenectomy.
| Study group | Role | What they receive |
|---|---|---|
| Frozen section | Patients underwent intraoperative sentinel node examination by frozen section Receives: Diagnostic Test: Intraoperative examination of sentinel node | |
| Scrape cytology | Patients underwent intraoperative sentinel node examination by scrape cytology Receives: Diagnostic Test: Intraoperative examination of sentinel node |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity for the diagnosis of metastatic lymph node intraoperatively
Measured: intraoperative test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2020
- Study start1 Feb 2016
- Primary completion1 Apr 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- More trials run by Ankara UniversityThe 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-control
- Time perspective
- Retrospective
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, salih taskin, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04560491
- Sponsor's protocol ID
- TRSGO SLN-003
- Acronym
- TRSGOSLN003
- Status last verified
- Sep 2020
- First submitted
- 18 Sep 2020
- Last updated
- 23 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Examination of Sentinel Node for The Decision of Further Lymphadenectomy in Clinical Early Stage Endometrial Cancer: A Diagnostic Study of Turkish Gynecologic Oncology Group (TRSGO-SLN-003)
- ClinicalTrials.gov ID
- NCT04560491
- Acronym / sponsor ID
- TRSGOSLN003 / TRSGO SLN-003
- Conditions
- Endometrial Cancer, Sentinel Lymph Node
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 1 Feb 2016 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 23 Sep 2020 (actual)
- 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.
More than half of the cases with macrometastatic sentinel lymph node (SLN) have non-SLN metastasis and leaving these nodes in-situ may impair the survival. This study assessed the diagnostic accuracy of intraoperative SLN frozen section examination and scrape cytology as a possible solution for management of SLN positive patients. Clinical early stage endometrial cancer patients who underwent SLN algorithm and intraoperative frozen section or scrape cytology to evaluate SLN status for metastasis were analyzed retrospectively. Intraoperative examination findings were compared with final pathology results and diagnostic accuracy of frozen section and scrape cytology were evaluated.
Detailed description
Frozen section: Lymph nodes up to 2 mm were embedded as a whole. Lymph nodes between 2-5 mm were cut in half along their long axis and nodes larger than 5 mm were sliced in neat, parallel slices at 2-3 mm intervals-slicing was perpendicular to the long axis of the node. Then whole of the SLNs were stained with hematoxylin and eosin (H\&E) and examined by frozen section.
Scrape Cytology: SLNs were cut into 3-mm-thick pieces along their long axis. If the lymph node was smaller than 3 mm, it was cut in half. Both sides of the pieces were scraped separately by an edge of a glass slide or a lancet gently. Obtained materials were smeared immediately onto a slide and placed in ethanol for fixation. Then, all slides were stained with H\&E and examined.
The results were reported to the surgeon as positive (metastatic) or negative with the numbers of lymph nodes. After intraoperative examination, lymph nodes were put into formalin solution and sent for final pathologic examination.
Data analyses were performed using SPSS Version 21.0 (IBM Corporation, Armonk, NYC, USA). Shapiro-Wilk test was performed to determine whether the data were normally distributed. Descriptive statistics of continuous variables were compared between groups using Mann-Whitney U test. The Chi-square test or Fisher's exact test (when chi-square test assumptions do not hold due to low expected cell counts) were used to compare categorical variables between groups. Continuous variables were presented as median and min-max values, whereas categorical variables were presented as number and percentage. A p value of <0.05 was considered statistically significant. Performance of each protocol to predict treatment success was assessed using confidence intervals with respect to sensitivity, specificity, positive predictive value, and negative predictive value.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Frozen section | – | Diagnostic Test: Intraoperative examination of sentinel nodePatients underwent intraoperative sentinel node examination by frozen section |
| Scrape cytology | – | Diagnostic Test: Intraoperative examination of sentinel nodePatients underwent intraoperative sentinel node examination by scrape cytology |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with clinical early stage endometrial cancer and underwent sentinel lymph node biopsy with intraoperative examination of sentinel node by either frozen section or scrape cytology.
Key inclusion criteria (1 listed)
- Patients with apparently early stage endometrial cancer whose SLNs were evaluated intraoperatively were included to this study
Key exclusion criteria (2 listed)
- Patients with gross metastatic disease
- Patients who had contraindications to dyes (iodine allergy or hepatic impairments)
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 |
|---|---|---|
| Intraoperative examination of sentinel nodeIntraoperative examination of sentinel node by either frozen section or scrape cytology to detect metastasis and decide for further lymphadenectomy. | Diagnostic test | Frozen section, Scrape cytology |
Primary outcome
Sensitivity for the diagnosis of metastatic lymph node intraoperatively
Time frame: intraoperative test
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 23 Sep 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Sentinel Lymph Node, run by Ankara University at 1 site in Turkey (Türkiye).
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 1 inclusion and 2 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 23 Sep 2020. 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 Turkey (Türkiye). 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?
Sensitivity for the diagnosis of metastatic lymph node intraoperatively (time frame: intraoperative test). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Sep 2020.