Endometrial AdenocarcinomaNCT03716414
Evaluation of the Efficacy for Sentinel Lymph Node Policy in High-risk Endometrial Carcinoma
An observational study of Endometrial Adenocarcinoma, run by Fudan University at 1 site in China.
Trial summary
To evaluate the efficacy of sentinel lymph node biopsy technique in patients with high-risk endometrial carcinoma, which provides the evidence that sentinel lymph node biopsy technique could substitute the systematic Lymph node dissection(LND). Read more about this study
- Who is it for?
- Ages 18 to 100 years, women only
- Conditions the study is for
- Endometrial Adenocarcinoma
- What is being tested?
- SLN mapping
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 78 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2018to 16 Feb 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 to 100 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged 18-100 years old with high-risk endometrial carcinoma (grade 3 endometroid endometrial cancer, deep myometrial invasion, non-endometrioid endometrial cancer, and Cervical invasion (in intraoperative frozen section examinations) and without no contraindication to surgery will be recruited.
Who may be able to join
- Age: 18~100 years.
- No contraindication to surgery.
- Signed and dated informed consent.
- high-risk endometrial cancer with grade 3, deep myometrial invasion, non-endometrioid endometrial cancer, and Cervical invasion (in intraoperative frozen section examinations).
- With any suspicious pelvic, para-aortic or distant lymph node metastasis in preoperative imaging tests including MRI/CT/positron emission computed tomography(PET)-CT.
Who cannot join
- Low-risk endometrioid endometrial cancer with grade 1-2, superficial myometrial invasion and tumor diameter < 2cm (in intraoperative frozen section examinations).
- Intermediate-risk endometrioid endometrial cancer with grade 1-2, superficial myometrial invasion and tumor diameter ≥ 2cm (in intraoperative frozen section examinations).
Trial locations and contacts
1 site in 1 country.
About this study
To evaluate the efficacy of sentinel lymph node biopsy technique in patients with high-risk endometrial carcinoma, which provides the evidence that sentinel lymph node biopsy technique could substitute the systematic Lymph node dissection(LND).
Read the detailed description
Comprehensive surgical staging for endometrial carcinoma(EC) is an indisputable staging and prognostic tool. The staging procedure includes total hysterectomy, bilateral salpingo-oophorectomy, and lymphadenectomy, omental biopsy if necessary. Since lymph node metastasis is one of the most important risk factors of prognosis. The dissection of lymph nodes has been used for staging, prognostic information, and to determine the need for adjuvant therapy. The approach to lymph node evaluation in women with EC is still a subject of debate. Practice varies across different institutions or surgeons. In general, the options for management of retroperitoneal lymph nodes include no lymph node dissection (LND), systematic LND only if the risk of lymph node metastasis exceeds a certain threshold, or routine sentinel LND following lymphatic mapping. lymphadenectomy is significantly associated with longer operating time, higher surgical costs, greater rate of infection, as well as the occurrence of lymphocysts and lymphedema, moreover, there is lack of evidence of a therapeutic benefit of LND, less invasive techniques have emerged as possible alternatives. The technique for lymphatic mapping and sentinel lymph node dissection (SLND) in EC has been refined and found a low false-negative rate for detection of positive lymph nodes. The 2018 National Comprehensive cancer Network (NCCN) guideline of uterus cancer states SLN mapping can be considered for the surgical staging of apparent uterine-confined malignancy when there is no metastasis demonstrated by imaging studies or no obvious extrauterine disease at exploration. It indicates low-risk patients could avoid those side effects of the systematic Lymph node dissection. Whether high-risk patients (grade 3, deep myometrial invasion, non-endometrioid endometrial cancer, and Cervical invasion) can be benefited from this technique? This prospective cohort study is designed to To evaluate the efficacy of sentinel lymph node biopsy technique in patients with high-risk endometrial carcinoma. Surgery should be performed within a maximum of 4 weeks from the patient's first consultation.
- Conditions
- Endometrial Adenocarcinoma
- Being tested
- SLN mapping
- Keywords
- Sentinel lymph node
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SLN mappingProcedure or surgery
Intra-operative SLN mapping with indocyanine green: Intracervical injection will be performed by the surgeon. Sub-mucous injections will be performed with 50% diluted dye at 3 and 9 o'clock positions. 1ml injection contained infracyanine green will be injected deeply into the stroma of the cervix (1cm-depth), and Arms Assigned Interventions another 1ml will be injected superficially (2mm-depth).
The time between the injection and the search for SLN must be as soon as possible.
| Study group | Role | What they receive |
|---|---|---|
| Experimental SLN arm | Experimental SLN arm
1. Intra-operative sentinel lymph node (SLN) mapping with indocyanine green injected into the stroma of the cervix.
2. Full bilateral laparoscopic lymphadenectomy and hysterectomy:
If bilateral SLN are detected, all positive SLN will be removed. Then the surgeons proceed to a total hysterectomy, bilateral salpingo-oophorectomy, and lymphadenectomy including complete pelvic lymphadenectomy and aortic lymph node dissection.
If only unilateral SLN or non SLN are detected, surgeons will proceed to complete pelvic lymphadenectomy and aortic lymph node dissection. Receives: Procedure: SLN mapping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance Analysis
Using the final pathological diagnosis as the Gold Standard, the investigators will calculate the sensitivity, specificity, and predictive accuracy of mapping and detection of SLN with metastatic disease.
Measured: Within 14 days after the surgery
Secondary outcomes (4)
Postoperative complications
calculate the incidence of complications such as lymph cysts, lymph edema, and postoperative fever etc.
Measured: 1 years after the surgery
Recurrence rate
The recurrence rate will be followed up.
Measured: 5 years after the surgery
Adjuvant therapy rate
The adjuvant therapy rate will be followed up.
Measured: 5 years after the surgery
5-year survival rate
The 5-year survival rate will be followed up.
Measured: 5 years after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2018
- Study start1 Nov 2018
- Primary completion16 Feb 2020
- Study completion16 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Fudan 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaojun Chen, Fudan University
- Investigators
- Chao Wang, Ph.D., Study director, Obstetrics and Gynecology Hospital, Fudan UniversityXuezhen Luo, Ph.D., Principal investigator, Obstetrics and Gynecology Hospital, Fudan UniversityXiaojun Chen, Ph.D., Study chair, Obstetrics and Gynecology Hospital, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03716414
- Sponsor's protocol ID
- 53201016
- Status last verified
- Jun 2020
- First submitted
- 21 Oct 2018
- Last updated
- 23 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy for Sentinel Lymph Node Policy in High-risk Endometrial Carcinoma
- ClinicalTrials.gov ID
- NCT03716414
- Acronym / sponsor ID
- 53201016
- Conditions
- Endometrial Adenocarcinoma
- Keywords
- Sentinel lymph node
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 16 Feb 2020 (actual)
- Study completion
- 16 Feb 2020 (actual)
- First posted
- 23 Oct 2018 (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.
To evaluate the efficacy of sentinel lymph node biopsy technique in patients with high-risk endometrial carcinoma, which provides the evidence that sentinel lymph node biopsy technique could substitute the systematic Lymph node dissection(LND).
Detailed description
Comprehensive surgical staging for endometrial carcinoma(EC) is an indisputable staging and prognostic tool. The staging procedure includes total hysterectomy, bilateral salpingo-oophorectomy, and lymphadenectomy, omental biopsy if necessary. Since lymph node metastasis is one of the most important risk factors of prognosis. The dissection of lymph nodes has been used for staging, prognostic information, and to determine the need for adjuvant therapy. The approach to lymph node evaluation in women with EC is still a subject of debate. Practice varies across different institutions or surgeons. In general, the options for management of retroperitoneal lymph nodes include no lymph node dissection (LND), systematic LND only if the risk of lymph node metastasis exceeds a certain threshold, or routine sentinel LND following lymphatic mapping. lymphadenectomy is significantly associated with longer operating time, higher surgical costs, greater rate of infection, as well as the occurrence of lymphocysts and lymphedema, moreover, there is lack of evidence of a therapeutic benefit of LND, less invasive techniques have emerged as possible alternatives. The technique for lymphatic mapping and sentinel lymph node dissection (SLND) in EC has been refined and found a low false-negative rate for detection of positive lymph nodes. The 2018 National Comprehensive cancer Network (NCCN) guideline of uterus cancer states SLN mapping can be considered for the surgical staging of apparent uterine-confined malignancy when there is no metastasis demonstrated by imaging studies or no obvious extrauterine disease at exploration. It indicates low-risk patients could avoid those side effects of the systematic Lymph node dissection. Whether high-risk patients (grade 3, deep myometrial invasion, non-endometrioid endometrial cancer, and Cervical invasion) can be benefited from this technique? This prospective cohort study is designed to To evaluate the efficacy of sentinel lymph node biopsy technique in patients with high-risk endometrial carcinoma. Surgery should be performed within a maximum of 4 weeks from the patient's first consultation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental SLN arm | – | Procedure: SLN mappingExperimental SLN arm 1. Intra-operative sentinel lymph node (SLN) mapping with indocyanine green injected into the stroma of the cervix. 2. Full bilateral laparoscopic lymphadenectomy and hysterectomy: If bilateral SLN are detected, all positive SLN will be removed. Then the surgeons proceed to a total hysterectomy, bilateral salpingo-oophorectomy, and lymphadenectomy including complete pelvic lymphadenectomy and aortic lymph node dissection. If only unilateral SLN or non SLN are detected, surgeons will proceed to complete pelvic lymphadenectomy and aortic lymph node dissection. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 18-100 years old with high-risk endometrial carcinoma (grade 3 endometroid endometrial cancer, deep myometrial invasion, non-endometrioid endometrial cancer, and Cervical invasion (in intraoperative frozen section examinations) and without no contraindication to surgery will be recruited.
Key inclusion criteria (5 listed)
- Age: 18~100 years.
- No contraindication to surgery.
- Signed and dated informed consent.
- high-risk endometrial cancer with grade 3, deep myometrial invasion, non-endometrioid endometrial cancer, and Cervical invasion (in intraoperative frozen section examinations).
- With any suspicious pelvic, para-aortic or distant lymph node metastasis in preoperative imaging tests including MRI/CT/positron emission computed tomography(PET)-CT.
Key exclusion criteria (2 listed)
- Low-risk endometrioid endometrial cancer with grade 1-2, superficial myometrial invasion and tumor diameter < 2cm (in intraoperative frozen section examinations).
- Intermediate-risk endometrioid endometrial cancer with grade 1-2, superficial myometrial invasion and tumor diameter ≥ 2cm (in intraoperative frozen section examinations).
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 |
|---|---|---|
| SLN mappingIntra-operative SLN mapping with indocyanine green: Intracervical injection will be performed by the surgeon. Sub-mucous injections will be performed with 50% diluted dye at 3 and 9 o'clock positions. 1ml injection contained infracyanine green will be injected deeply into the stroma of the cervix (1cm-depth), and Arms Assigned Interventions another 1ml will be injected superficially (2mm-depth). The time between the injection and the search for SLN must be as soon as possible. | Procedure or surgery | Experimental SLN arm |
Primary outcome
Performance Analysis
Time frame: Within 14 days after the surgery
Using the final pathological diagnosis as the Gold Standard, the investigators will calculate the sensitivity, specificity, and predictive accuracy of mapping and detection of SLN with metastatic disease.
4 secondary outcomes
Postoperative complications
Time frame: 1 years after the surgery
Recurrence rate
Time frame: 5 years after the surgery
Adjuvant therapy rate
Time frame: 5 years after the surgery
5-year survival rate
Time frame: 5 years after the surgery
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 Jun 2020.
- Individual participant dataSharing planned: Undecided
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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.
Chao Wang, Ph.D. study director
Obstetrics and Gynecology Hospital, Fudan University
Xuezhen Luo, Ph.D. principal investigator
Obstetrics and Gynecology Hospital, Fudan University
Xiaojun Chen, Ph.D. study chair
Obstetrics and Gynecology Hospital, Fudan University
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 Adenocarcinoma, run by Fudan University at 1 site in China.
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 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 Jun 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 China. 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?
Performance Analysis (time frame: Within 14 days after the 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 23 Jun 2020.