Sentinel Lymph NodeNCT03838055
Sentinel Node Detection in Endometrial Cancer: A Consolidation Study on Detection Rates of Metastatic Disease
A study testing Injection of tracer ( ICG) and detection of sentinel lymph nodes in people with Sentinel Lymph Node and Endometrial Cancer, run by Region Skane at 1 site in Sweden.
Trial summary
Evaluation of removal of Sentinel lymph nodes only for detection of pelvic lymph node metastases in high risk and low risk endometrial cancer. Read more about this study
- Who is it for?
- Ages 18 to 85 years, women only
- Conditions the study is for
- Sentinel Lymph Node, Endometrial Cancer, Lymphedema
- What is being tested?
- Injection of tracer ( ICG) and detection of sentinel lymph nodes
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 362 participants
- Where
- 1 siteSweden
- Study dates
- Feb 2019to Dec 2023
- 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 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women of age 18 years and older at the time of informed consent.
- Women with a pathologically proven endometrial carcinoma of any histologic subtype or grade, clinically stage I-II planned for primary surgery
- A uterine size allowing minimally invasive surgery
- Women must be able to understand and sign an informed consent in Swedish language.
- Absence of any exclusion criteria
Who cannot join
- Non consenting patients
- Ongoing pregnancy
- Inability to understand written and/or oral study information
- WHO performance status or conditions contraindicating adjuvant oncological treatment (WHO III or more)
- Previous lower limb lymphedema ( only for the lymphedema part of study)
- Evidence of locally advanced disease or intraabdominal/distant metastases at preoperative CT, MRI or ultrasonography.
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- Surgical contraindication to a laparoscopic approach or lymphadenectomy at surgeons discretion.
- Anesthesiologic contraindication to a laparoscopic approach at the anesthetist's discretion
- Allergy to Iodine
- Patients with a known liver disease
- Patients with a bleeding disorder or mandatory antithrombotic treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sentinel Lymph Node Detection in Endometrial Cancer: A Consolidation Study
Evaluation of removal of Sentinel lymph nodes only for detection of pelvic lymph node metastases in high risk and low risk endometrial cancer.
Read the detailed description
Consecutive patients with- and low risk endometrial cancer will be approached for eligibility for inclusion in a study evaluating the detection rates of pelvic metastatic disease by detection and removal of Sentinel lymph nodes only, i.e with no further lymphadenectomy.
A re-staging will be performed in case of metastatic Sentinel lymph nodes to guide adjuvant treatment.
The detection rate will be evaluated from a non-inferiority perspective against the expected rate of nodal metastases based on detailed final histological data.
Adverse events related the intervention ( Injection of tracer (ICG) and removal of sentinel nodes), time for the intervention, and an objective evaluation of lymphatic complications (lymphoedema) will be performed in addition to the use of a validated lymphoedema QOL questionnaire.
- Conditions
- Sentinel Lymph Node, Endometrial Cancer, Lymphedema
- Being tested
- Injection of tracer ( ICG) and detection of sentinel lymph nodes
- Medical subject headings
- Endometrial Neoplasms, Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injection of tracer ( ICG) and detection of sentinel lymph nodesProcedure or surgery
Pelvic SLN's defined by ICG injected cervically
| Study group | Role | What they receive |
|---|---|---|
| SLN only | Experimental | Pelvic SLN's defined by ICG injected cervically Receives: Procedure: Injection of tracer ( ICG) and detection of sentinel lymph nodes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection rate of pelvic metastatic disease in endometrial cancer
The detection rate will be evaluated from a non-inferiority perspective based on a null-hypothesis of 4% less than an expected rate of 12% nodal metastases
Measured: 3 years from start inclusion with an interim analysis after 150 patients
Operative time used for the study intervention ( injection of ICG and identification and removal of sentinel lymph nodes
Exact measurements of time allocated for the SLN procedure as such.
Measured: 3 years from start inclusion
Secondary outcomes (2)
Incidence of lymphedema after removal of sentinel lymph nodes
Objective measurement lymphedema defined by of leg volume before and after surgery
Measured: 4 years including at least one year follow up
intraoperative adverse events associated with the study intervention
Detailed registration of adverse events associated with the SLN procedure as such
Measured: 3 years from start inclusion or after 150 patients if study stopped at interim analysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2019
- Study startFeb 2019 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sentinel Lymph NodeStudies of the same condition, open and under way.
- More trials run by Region SkaneThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective cohort study
- Masking
- None (open label)
- Enrolment
- 362 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jan Persson, Ass Prof, Principal investigator, RegionSkane, department of OB&G, Skåne university hospital, Lund
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03838055
- Sponsor's protocol ID
- RegionSkaneKKLund3
- Status last verified
- Jan 2019
- First submitted
- 21 Dec 2018
- Last updated
- 12 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sentinel Lymph Node Detection in Endometrial Cancer: A Consolidation Study
- ClinicalTrials.gov ID
- NCT03838055
- Acronym / sponsor ID
- RegionSkaneKKLund3
- Conditions
- Sentinel Lymph Node, Endometrial Cancer, Lymphedema
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 362 participants (estimated)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- Feb 2019 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 12 Feb 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.
Evaluation of removal of Sentinel lymph nodes only for detection of pelvic lymph node metastases in high risk and low risk endometrial cancer.
Detailed description
Consecutive patients with- and low risk endometrial cancer will be approached for eligibility for inclusion in a study evaluating the detection rates of pelvic metastatic disease by detection and removal of Sentinel lymph nodes only, i.e with no further lymphadenectomy.
A re-staging will be performed in case of metastatic Sentinel lymph nodes to guide adjuvant treatment.
The detection rate will be evaluated from a non-inferiority perspective against the expected rate of nodal metastases based on detailed final histological data.
Adverse events related the intervention ( Injection of tracer (ICG) and removal of sentinel nodes), time for the intervention, and an objective evaluation of lymphatic complications (lymphoedema) will be performed in addition to the use of a validated lymphoedema QOL questionnaire.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective cohort study
| Arm | Type | Receives |
|---|---|---|
| SLN only | Experimental | Procedure: Injection of tracer ( ICG) and detection of sentinel lymph nodesPelvic SLN's defined by ICG injected cervically |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Women of age 18 years and older at the time of informed consent.
- Women with a pathologically proven endometrial carcinoma of any histologic subtype or grade, clinically stage I-II planned for primary surgery
- A uterine size allowing minimally invasive surgery
- Women must be able to understand and sign an informed consent in Swedish language.
- Absence of any exclusion criteria
Key exclusion criteria (11 listed)
- Non consenting patients
- Ongoing pregnancy
- Inability to understand written and/or oral study information
- WHO performance status or conditions contraindicating adjuvant oncological treatment (WHO III or more)
- Previous lower limb lymphedema ( only for the lymphedema part of study)
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 |
|---|---|---|
| Injection of tracer ( ICG) and detection of sentinel lymph nodesPelvic SLN's defined by ICG injected cervically | Procedure or surgery | SLN only |
Primary outcome
Detection rate of pelvic metastatic disease in endometrial cancer
Time frame: 3 years from start inclusion with an interim analysis after 150 patients
The detection rate will be evaluated from a non-inferiority perspective based on a null-hypothesis of 4% less than an expected rate of 12% nodal metastases
Operative time used for the study intervention ( injection of ICG and identification and removal of sentinel lymph nodes
Time frame: 3 years from start inclusion
Exact measurements of time allocated for the SLN procedure as such.
2 secondary outcomes
Incidence of lymphedema after removal of sentinel lymph nodes
Time frame: 4 years including at least one year follow up
intraoperative adverse events associated with the study intervention
Time frame: 3 years from start inclusion or after 150 patients if study stopped at interim analysis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2019.
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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.
Jan Persson, Ass Prof principal investigator
RegionSkane, department of OB&G, Skåne university hospital, Lund
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Injection of tracer ( ICG) and detection of sentinel lymph nodes in people with Sentinel Lymph Node and Endometrial Cancer, run by Region Skane at 1 site in Sweden.
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 11 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: status not confirmed, as of the sponsor's last update on 12 Feb 2019. 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 Sweden. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jan Persson, Ass prof (0046733522080, jan.persson@med.lu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection rate of pelvic metastatic disease in endometrial cancer (time frame: 3 years from start inclusion with an interim analysis after 150 patients). The study lists 2 primary outcomes in all. 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 12 Feb 2019.