Endometrial CancerNCT03900104
Cervical and Endometrial Injection for Sentinel Lymph Node Detection in Endometrial Cancer
A study testing Transcervical endometrial injection of technetium 99 m-labeled human albumin colloid particles and Cervical injection of technetium 99 m-labeled human albumin colloid particles in people with Endometrial Cancer and Sentinel Lymph Node, run by Kocaeli University at 1 site in Turkey (Türkiye).
Trial summary
The investigators think that trans-cervical endometrial tracer injection will cause more paraaortic sentinel lymph node detection. Also, this application is easy, cost-effective and safer than hysteroscopic method. Transtubal tumor spearing will not occur with this method. Read more about this study
- Who is it for?
- Ages 18 to 90 years, women only
- Conditions the study is for
- Endometrial Cancer, Sentinel Lymph Node
- What is being tested?
- Transcervical endometrial injection of technetium 99 m-labeled human albumin colloid particles and Cervical injection of technetium 99 m-labeled human albumin colloid particles
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2019to 15 Jan 2020
- Phase
- Interventional
- 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 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Endometrial Cancer Patients
- Suitable patients for surgical staging
Who cannot join
- Patients who cannot undergo cervical or transcervical endometrial injection
- Pathology did not confirm endometrial cancer
- Sarcoma of the uterine corpus
- If a 90-day follow-up was not feasible
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cervical and Endometrial Injection for Sentinel Lymph Node Detection in Endometrial Cancer: A Prospective Randomized Trial
The investigators think that trans-cervical endometrial tracer injection will cause more paraaortic sentinel lymph node detection. Also, this application is easy, cost-effective and safer than hysteroscopic method. Transtubal tumor spearing will not occur with this method.
Read the detailed description
Endometrial tracer injection will be performed by cervical or transcervical endometrial methods. Pelvic and para-aortic sentinel lymph node detection capacity will be assessed in this study.
- Conditions
- Endometrial Cancer, Sentinel Lymph Node
- Being tested
- Transcervical endometrial injection of technetium 99 m-labeled human albumin colloid particles, Cervical injection of technetium 99 m-labeled human albumin colloid particles
- Keywords
- Endometrial Cancer, Sentinel Lymph Node, Paraaortic nodes involvement
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcervical endometrial injection of technetium 99 m-labeled human albumin colloid particlesProcedure or surgery
Transcervical endometrial injection of technetium 99 m-labeled human albumin colloid particles, in 5 mL saline, 2 hours before surgery. Injection performed with a trans-cervical catheter
Cervical injection of technetium 99 m-labeled human albumin colloid particlesProcedure or surgery
Cervical injection of technetium 99 m-labeled human albumin colloid particles, in 5 mL saline, 2 hours before surgery.
| Study group | Role | What they receive |
|---|---|---|
| Transcervical endometrial injection arm | Experimental | Tracer injection performed by a transcervical catheter in endometrial cancer patients. Receives: Procedure: Transcervical endometrial injection of technetium 99 m-labeled human albumin colloid particles |
| Cervical injection arm | Active comparator | Tracer injection was administered via the cervical route in endometrial cancer patients. Receives: Procedure: Cervical injection of technetium 99 m-labeled human albumin colloid particles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detected pelvic and paraaortic sentinel lymph node numbers
Detected pelvic and paraaortic sentinel lymph node numbers in pathological examination (Ultrastaging)
Measured: Postoperative 30 days
Secondary outcomes (1)
Numbers adverse events
Number of adverse events associated with the surgery
Measured: Postoperative 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2019
- Study start1 May 2019
- Primary completion1 Jan 2020
- Study completion15 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Şener Gezer, Kocaeli University
- Investigators
- Şener Gezer, M.D, Principal investigator, Kocaeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03900104
- Sponsor's protocol ID
- CEIN
- Status last verified
- Feb 2020
- First submitted
- 31 Mar 2019
- Last updated
- 20 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Solima E, Martinelli F, Ditto A, Maccauro M, Carcangiu M, Mariani L, Kusamura S, Fontanelli R, Grijuela B, Raspagliesi F. Diagnostic accuracy of sentinel node in endometrial cancer by using hysteroscopic injection of radiolabeled tracer. Gynecol Oncol. 2012 Sep;126(3):419-23. doi: 10.1016/j.ygyno.2012.05.025. Epub 2012 May 30.
PubMed 22659192Niikura H, Kaiho-Sakuma M, Tokunaga H, Toyoshima M, Utsunomiya H, Nagase S, Takano T, Watanabe M, Ito K, Yaegashi N. Tracer injection sites and combinations for sentinel lymph node detection in patients with endometrial cancer. Gynecol Oncol. 2013 Nov;131(2):299-303. doi: 10.1016/j.ygyno.2013.08.018. Epub 2013 Aug 27.
PubMed 23988415
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cervical and Endometrial Injection for Sentinel Lymph Node Detection in Endometrial Cancer: A Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT03900104
- Acronym / sponsor ID
- CEIN
- Conditions
- Endometrial Cancer, Sentinel Lymph Node
- Keywords
- Endometrial Cancer, Sentinel Lymph Node, Paraaortic nodes involvement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 15 Jan 2020 (actual)
- First posted
- 2 Apr 2019 (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.
The investigators think that trans-cervical endometrial tracer injection will cause more paraaortic sentinel lymph node detection. Also, this application is easy, cost-effective and safer than hysteroscopic method. Transtubal tumor spearing will not occur with this method.
Detailed description
Endometrial tracer injection will be performed by cervical or transcervical endometrial methods. Pelvic and para-aortic sentinel lymph node detection capacity will be assessed in this study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transcervical endometrial injection arm | Experimental | Procedure: Transcervical endometrial injection of technetium 99 m-labeled human albumin colloid particlesTracer injection performed by a transcervical catheter in endometrial cancer patients. |
| Cervical injection arm | Active comparator | Procedure: Cervical injection of technetium 99 m-labeled human albumin colloid particlesTracer injection was administered via the cervical route in endometrial cancer patients. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Endometrial Cancer Patients
- Suitable patients for surgical staging
Key exclusion criteria (4 listed)
- Patients who cannot undergo cervical or transcervical endometrial injection
- Pathology did not confirm endometrial cancer
- Sarcoma of the uterine corpus
- If a 90-day follow-up was not feasible
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 |
|---|---|---|
| Transcervical endometrial injection of technetium 99 m-labeled human albumin colloid particlesTranscervical endometrial injection of technetium 99 m-labeled human albumin colloid particles, in 5 mL saline, 2 hours before surgery. Injection performed with a trans-cervical catheter | Procedure or surgery | Transcervical endometrial injection arm |
| Cervical injection of technetium 99 m-labeled human albumin colloid particlesCervical injection of technetium 99 m-labeled human albumin colloid particles, in 5 mL saline, 2 hours before surgery. | Procedure or surgery | Cervical injection arm |
Primary outcome
Detected pelvic and paraaortic sentinel lymph node numbers
Time frame: Postoperative 30 days
Detected pelvic and paraaortic sentinel lymph node numbers in pathological examination (Ultrastaging)
1 secondary outcome
Numbers adverse events
Time frame: Postoperative 90 days
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 20 Feb 2020.
- Background: PubMed 22659192Solima E, Martinelli F, Ditto A, Maccauro M, Carcangiu M, Mariani L, Kusamura S, Fontanelli R, Grijuela B, Raspagliesi F. Diagnostic accuracy of sentinel node in endometrial cancer by using hysteroscopic injection of radiolabeled tracer. Gynecol Oncol. 2012 Sep;126(3):419-23. doi: 10.1016/j.ygyno.2012.05.025. Epub 2012 May 30.
- Background: PubMed 23988415Niikura H, Kaiho-Sakuma M, Tokunaga H, Toyoshima M, Utsunomiya H, Nagase S, Takano T, Watanabe M, Ito K, Yaegashi N. Tracer injection sites and combinations for sentinel lymph node detection in patients with endometrial cancer. Gynecol Oncol. 2013 Nov;131(2):299-303. doi: 10.1016/j.ygyno.2013.08.018. Epub 2013 Aug 27.
- 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.
Şener Gezer, M.D principal investigator
Kocaeli University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcervical endometrial injection of technetium 99 m-labeled human albumin colloid particles and Cervical injection of technetium 99 m-labeled human albumin colloid particles in people with Endometrial Cancer and Sentinel Lymph Node, run by Kocaeli 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 2 inclusion and 4 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 20 Feb 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?
Detected pelvic and paraaortic sentinel lymph node numbers (time frame: Postoperative 30 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 NCT03900104, which also lists 2 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 20 Feb 2020.