Cancer of the EndometriumSentimetreNCT03024398
Evaluation of the Fluorescent Green of Indocyanine in the Detection of Sentinel Lymph Node in Endometrial Cancer
An observational study of Cancer of the Endometrium, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Selective lymphadenectomy Sentinel (LSS). This technique is already well established in breast cancer and melanoma and more recently in vulvar and cervical cancer. Compared to lymphadenectomy, it has several theoretical advantages: this is a sensitive technique with a detection rate of> 90% and a false negative rate… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cancer of the Endometrium
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2017to 1 Jul 2023
- 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: Patient with confirmed biopsy endometrial cancer
Who may be able to join
- Major patient, without guardianship or curatorship.
- patient with endometrial cancer confirmed by biopsy.
- Invasive cancer stage FIGO I at intermediate risk and high risk and II according to the FIGO classification.
- need for surgical staging.
- performing an endovaginal ultrasound or a pelvic MRI in preoperative, if contraindication to MRI, performing a CT scan.
- subject affiliated to a social health insurance scheme.
- speaking and reading French.
- subject having dated and signed informed consent.
Who cannot join
- pregnancy in progress.
- FIGO III and IV stage diagnosed preoperatively or intraoperatively.
- Cure or pre-surgery that may alter the uterine lymphatic drainage (conization, myomectomy).
- MRI or CT scan of suspected lymph nodes.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service de gynécologie-obstétrique - Hôpital de Hautepierre
Strasbourg, 67091
Cherif Youssef AKLADIOS, MD, 33 3 88 12 83 35, cherif.youssef.azer@chru-strasbourg.fr
Jean-Jacques BALDAUF, MD, PhD, 33 3 88 12 83 35, Jean-Jacques.Baldauf@chru-strasbourg.fr
About this study
Selective lymphadenectomy Sentinel (LSS). This technique is already well established in breast cancer and melanoma and more recently in vulvar and cervical cancer.
Compared to lymphadenectomy, it has several theoretical advantages:
Read more
- this is a sensitive technique with a detection rate of> 90% and a false negative rate of <5%.
- the anatomopathological techniques used (immunohistochemistry with anti-cytokeratin antibodies, serial sections) are more sensitive than the standard histological analysis of lymphadenectomy, which allows an improvement in the detection of metastases (micro-metastases, isolated tumor cells). In the SENTI-ENDO study, it was possible to detect lymph node metastases in 11% of patients with low-risk endometrial cancer and in 15% of intermediate-risk patients.
- it avoids short-term and long-term operative and post-operative morbidity of lymphadenectomy.
Early studies of LSS in endometrial cancer demonstrated superior efficacy of the colorimetric method coupled with the Technetium 99m isotopic method with an overall detection rate of 78% [95% CI: 73-84]. The fluorescent green of indocyanine appears to give better results with an overall detection rate of 94% and a bilateral detection rate of 80%.
It seemed useful to take stock of this technique using this new dye.
- Conditions
- Cancer of the Endometrium
- Medical subject headings
- Endometrial Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of sentinel node
Measured: 1 hour after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2017 (estimated)
- Study start1 Jan 2017
- Primary completionJul 2023 (estimated)
- Study completion1 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer of the EndometriumStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cherif Youssef AKLADIOS, MD, Study director, University Hospital, Strasbourg, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03024398
- Sponsor's protocol ID
- 6492
- Acronym
- Sentimetre
- Status last verified
- Jun 2023
- First submitted
- 5 Jan 2017
- Last updated
- 18 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Fluorescent Green of Indocyanine in the Detection of Sentinel Lymph Node in Endometrial Cancer
- ClinicalTrials.gov ID
- NCT03024398
- Acronym / sponsor ID
- Sentimetre / 6492
- Conditions
- Cancer of the Endometrium
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- 1 Jul 2023 (estimated)
- First posted
- 18 Jan 2017 (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.
Selective lymphadenectomy Sentinel (LSS). This technique is already well established in breast cancer and melanoma and more recently in vulvar and cervical cancer.
Compared to lymphadenectomy, it has several theoretical advantages:
- this is a sensitive technique with a detection rate of> 90% and a false negative rate of <5%.
- the anatomopathological techniques used (immunohistochemistry with anti-cytokeratin antibodies, serial sections) are more sensitive than the standard histological analysis of lymphadenectomy, which allows an improvement in the detection of metastases (micro-metastases, isolated tumor cells). In the SENTI-ENDO study, it was possible to detect lymph node metastases in 11% of patients with low-risk endometrial cancer and in 15% of intermediate-risk patients.
- it avoids short-term and long-term operative and post-operative morbidity of lymphadenectomy.
Early studies of LSS in endometrial cancer demonstrated superior efficacy of the colorimetric method coupled with the Technetium 99m isotopic method with an overall detection rate of 78% [95% CI: 73-84]. The fluorescent green of indocyanine appears to give better results with an overall detection rate of 94% and a bilateral detection rate of 80%.
It seemed useful to take stock of this technique using this new dye.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with confirmed biopsy endometrial cancer
Key inclusion criteria (8 listed)
- Major patient, without guardianship or curatorship.
- patient with endometrial cancer confirmed by biopsy.
- Invasive cancer stage FIGO I at intermediate risk and high risk and II according to the FIGO classification.
- need for surgical staging.
- performing an endovaginal ultrasound or a pelvic MRI in preoperative, if contraindication to MRI, performing a CT scan.
Key exclusion criteria (4 listed)
- pregnancy in progress.
- FIGO III and IV stage diagnosed preoperatively or intraoperatively.
- Cure or pre-surgery that may alter the uterine lymphatic drainage (conization, myomectomy).
- MRI or CT scan of suspected lymph nodes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Detection of sentinel node
Time frame: 1 hour after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
- 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.
Cherif Youssef AKLADIOS, MD study director
University Hospital, Strasbourg, France
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 Cancer of the Endometrium, run by University Hospital, Strasbourg, France at 1 site in France.
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 8 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: status not confirmed, as of the sponsor's last update on 18 Jun 2023. 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 France. 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 Cherif Youssef AKLADIOS, MD (33 3 88 12 83 35, cherif.youssef.azer@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of sentinel node (time frame: 1 hour after surgery). 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 18 Jun 2023.