Endometrial CancerSENTRYNCT04972682
[SENTRY] Tailoring Postoperative Management Through Sentinel Lymph Node Biopsy in Low- and Intermediate-Risk Endometrial Cancer
A study testing Laparoscopic total hysterectomy with bilateral salpingo-oophorectomy and sentinel lymph node biopsy in people with Endometrial Cancer and Endometrial Neoplasms, run by Moscow City Oncology Hospital No. 62 at 1 site in Russia.
Trial summary
While total hysterectomy without lymph node staging is standard for low- and intermediate-risk endometrial cancer, certain histopathologic factors can necessitate additional interventions. Our study assesses the influence of sentinel lymph node (SLN) biopsy on postoperative decision-making. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Cancer, Endometrial Neoplasms, Endometrial Adenocarcinoma
- What is being tested?
- Laparoscopic total hysterectomy with bilateral salpingo-oophorectomy and sentinel lymph node biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteRussia
- Study dates
- 1 Jul 2021to 15 Apr 2024
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Histologically verified low-grade endometrioid adenocarcinoma of the endometrium (G1-G2)
- FIGO stage IA
- FIGO stage IB and II when LND is contraindicated
- No contraindications for surgery
- Signed informed consent
Who cannot join
- • Age <18 years
- Presence of tumor spread outside the corpus uteri
- Absence of tumor invasion into the myometrium
- High-grade tumor (G3)
- Bokhman type 2 tumor (e.g., clear cell adenocarcinoma, serous adenocarcinoma, carcinosarcoma, endometrial stromal sarcoma)
- Preoperative treatment of endometrial cancer including radiotherapy, systemic chemotherapy, or hormone therapy
Show all 11Show fewer
- Prior pelvic or retroperitoneal LND
- History of surgeries on the uterus and uterine appendages, with exceptions such as cesarean section, tubectomy, oophorectomy, ovarian resection, ovarian biopsy, and ovarian cauterization
- Allergy to iodine-containing drugs
- Contraindications to surgical treatment
- Lack of signed informed consent
Trial locations and contacts
1 site in 1 country.
Russia1 site
1. Department of Gynecologic Oncology, Moscow City Oncology Hospital No. 62
Istra, Moscow Oblast, 143515
About this study
Official title: Tailoring Postoperative Management Through Sentinel Lymph Node Biopsy in Low- and Intermediate-Risk Endometrial Cancer: a Prospective Open-label Single-arm Clinical Trial
While total hysterectomy without lymph node staging is standard for low- and intermediate-risk endometrial cancer, certain histopathologic factors can necessitate additional interventions. Our study assesses the influence of sentinel lymph node (SLN) biopsy on postoperative decision-making.
- Conditions
- Endometrial Cancer, Endometrial Neoplasms, Endometrial Adenocarcinoma, Endometrial Cancer Stage I, Endometrial Cancer Stage II, Endometrial Endometrioid Adenocarcinoma
- Being tested
- Laparoscopic total hysterectomy with bilateral salpingo-oophorectomy and sentinel lymph node biopsy
- Keywords
- Endometrial Cancer, Endometrial Adenocarcinoma, Sentinel Lymph Node Biopsy, Laparoscopic Hysterectomy, Adjuvant Therapy, FIGO
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic total hysterectomy with bilateral salpingo-oophorectomy and sentinel lymph node biopsyProcedure or surgery
Laparoscopic total hysterectomy, bilateral salpingo-oophorectomy (BSO), and sentinel lymph node (SLN) biopsy are executed by 1 of 5 experienced gynecologic oncologists. SLN mapping utilizes indocyanine green (ICG) at a standard concentration of 2.5 mg/mL - 1 mL is injected into the cervix at the 3 and 9 o'clock positions (total dose - 5 mg) to a depth of 5-10 mm, initiated right after general anesthesia induction. Diagnostic laparoscopy employs the Image 1S equipment (KARL STORZ©, Tuttlingen, Germany). Upon examination, fluorescence in the near-infrared spectrum is observed. Successful mapping is indicated by identifying a lymphatic vessel with at least one LN. Detected SLNs are then extracted, and the total hysterectomy with BSO is completed. SLN frozen section remains at the surgeon's discretion. If metastasis surfaces in the SLN either during the frozen section or routine assessment, the option for systematic LN dissection in a subsequent procedure exists although not mandatory.
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic total hysterectomy with bilateral salpingo-oophorectomy and sentinel lymph node biopsy | Experimental | This arm includes patients with endometrioid adenocarcinoma of the endometrium of low- and intermediate-risk who will undergo a laparoscopic total hysterectomy and bilateral salpingo-oophorectomy with sentinel lymph node biopsy (SLNB) performed with near-infrared-guided surgery using indocyanine green (ICG). Receives: Procedure: Laparoscopic total hysterectomy with bilateral salpingo-oophorectomy and sentinel lymph node biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in postoperative treatment strategy
The rate of change in postoperative treatment based on the SLNB results and postoperative histology (percentage). A change in postoperative treatment strategy is defined as any difference between treatment plans set by the tumor board before and after receiving the SLN biopsy information.
Measured: Up to 3 weeks after surgery
Secondary outcomes (9)
Adjustments in FIGO staging
The rate of change in disease stage based on SLNB results and postoperative histology (percentage).
Measured: Up to 3 weeks after surgery
Bilateral SLN detection
The rate of bilateral SLN detection (percentage).
Measured: At the end of the surgery - 1 day
Details of intraoperative complications of SLN biopsy
The actual list of intraoperative complications associated with SLN mapping and biopsy. They include but are not limited to an intraoperative bleeding, small and large bowel injury, ureter and bladder injury, nerve injury, and allergic reaction to indocyanine green (ICG).
Measured: At the end of the surgery - 1 day
The rate of intraoperative complications of SLN biopsy
Percentage of patients experiencing intraoperative complications associated with SLN mapping and biopsy listed above.
Measured: At the end of the surgery - 1 day
Major postoperative morbidity
Major postoperative morbidity following the procedure (percentage).
Measured: Up to 30 days after surgery
Postoperative mortality
Postoperative mortality following the procedure (percentage).
Measured: Up to 30 days after surgery
Incidence of lymphedema
The rate of lower extremities lymphedema (percentage).
Measured: Up to 24 months after surgery
Pelvic recurrence rate
The percentage of patients experiencing pelvic recurrence after surgical treatment.
Measured: 24 months after surgery
Time to pelvic recurrence
Time from surgical treatment to detected pelvic recurrence in months.
Measured: 24 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2021
- Study start1 Jul 2021
- Primary completion15 Aug 2023
- Study completion15 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A single-center prospective open-label single-arm clinical trial
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Moscow City Oncology Hospital No. 62
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04972682
- Sponsor's protocol ID
- MCOH62-07-08-21
- Acronym
- SENTRY
- Status last verified
- May 2024
- First submitted
- 12 Jul 2021
- Last updated
- 7 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sorokin P, Novozhilov M, Utkin D, Abduragimova Z, Dudina I, Nikiforchin A, Kulikova S. Tailoring postoperative management through sentinel lymph node biopsy in low- and intermediate-risk endometrial cancer - the SENTRY clinical trial. Klin Onkol. 2024;38(2):126-133. doi: 10.48095/ccko2024126.
PubMed 38697821
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tailoring Postoperative Management Through Sentinel Lymph Node Biopsy in Low- and Intermediate-Risk Endometrial Cancer: a Prospective Open-label Single-arm Clinical Trial
- ClinicalTrials.gov ID
- NCT04972682
- Acronym / sponsor ID
- SENTRY / MCOH62-07-08-21
- Conditions
- Endometrial Cancer, Endometrial Neoplasms, Endometrial Adenocarcinoma, Endometrial Cancer Stage I, Endometrial Cancer Stage II, Endometrial Endometrioid Adenocarcinoma
- Keywords
- Endometrial Cancer, Endometrial Adenocarcinoma, Sentinel Lymph Node Biopsy, Laparoscopic Hysterectomy, Adjuvant Therapy, FIGO
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Moscow City Oncology Hospital No. 62Other government
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 15 Aug 2023 (actual)
- Study completion
- 15 Apr 2024 (actual)
- First posted
- 22 Jul 2021 (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.
While total hysterectomy without lymph node staging is standard for low- and intermediate-risk endometrial cancer, certain histopathologic factors can necessitate additional interventions. Our study assesses the influence of sentinel lymph node (SLN) biopsy on postoperative decision-making.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A single-center prospective open-label single-arm clinical trial
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic total hysterectomy with bilateral salpingo-oophorectomy and sentinel lymph node biopsy | Experimental | Procedure: Laparoscopic total hysterectomy with bilateral salpingo-oophorectomy and sentinel lymph node biopsyThis arm includes patients with endometrioid adenocarcinoma of the endometrium of low- and intermediate-risk who will undergo a laparoscopic total hysterectomy and bilateral salpingo-oophorectomy with sentinel lymph node biopsy (SLNB) performed with near-infrared-guided surgery using indocyanine green (ICG). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥18 years
- Histologically verified low-grade endometrioid adenocarcinoma of the endometrium (G1-G2)
- FIGO stage IA
- FIGO stage IB and II when LND is contraindicated
- No contraindications for surgery
Key exclusion criteria (11 listed)
- • Age <18 years
- Presence of tumor spread outside the corpus uteri
- Absence of tumor invasion into the myometrium
- High-grade tumor (G3)
- Bokhman type 2 tumor (e.g., clear cell adenocarcinoma, serous adenocarcinoma, carcinosarcoma, endometrial stromal sarcoma)
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 |
|---|---|---|
| Laparoscopic total hysterectomy with bilateral salpingo-oophorectomy and sentinel lymph node biopsyLaparoscopic total hysterectomy, bilateral salpingo-oophorectomy (BSO), and sentinel lymph node (SLN) biopsy are executed by 1 of 5 experienced gynecologic oncologists. SLN mapping utilizes indocyanine green (ICG) at a standard concentration of 2.5 mg/mL - 1 mL is injected into the cervix at the 3 and 9 o'clock positions (total dose - 5 mg) to a depth of 5-10 mm, initiated right after general anesthesia induction. Diagnostic laparoscopy employs the Image 1S equipment (KARL STORZ©, Tuttlingen, Germany). Upon examination, fluorescence in the near-infrared spectrum is observed. Successful mapping is indicated by identifying a lymphatic vessel with at least one LN. Detected SLNs are then extracted, and the total hysterectomy with BSO is completed. SLN frozen section remains at the surgeon's discretion. If metastasis surfaces in the SLN either during the frozen section or routine assessment, the option for systematic LN dissection in a subsequent procedure exists although not mandatory. | Procedure or surgery | Laparoscopic total hysterectomy with bilateral salpingo-oophorectomy and sentinel lymph node biopsy |
Primary outcome
Change in postoperative treatment strategy
Time frame: Up to 3 weeks after surgery
The rate of change in postoperative treatment based on the SLNB results and postoperative histology (percentage). A change in postoperative treatment strategy is defined as any difference between treatment plans set by the tumor board before and after receiving the SLN biopsy information.
9 secondary outcomes
Adjustments in FIGO staging
Time frame: Up to 3 weeks after surgery
Bilateral SLN detection
Time frame: At the end of the surgery - 1 day
Details of intraoperative complications of SLN biopsy
Time frame: At the end of the surgery - 1 day
The rate of intraoperative complications of SLN biopsy
Time frame: At the end of the surgery - 1 day
Major postoperative morbidity
Time frame: Up to 30 days after surgery
Postoperative mortality
Time frame: Up to 30 days after surgery
Incidence of lymphedema
Time frame: Up to 24 months after surgery
Pelvic recurrence rate
Time frame: 24 months after surgery
Time to pelvic recurrence
Time frame: 24 months after 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 7 May 2024.
- Results publication: PubMed 38697821Sorokin P, Novozhilov M, Utkin D, Abduragimova Z, Dudina I, Nikiforchin A, Kulikova S. Tailoring postoperative management through sentinel lymph node biopsy in low- and intermediate-risk endometrial cancer - the SENTRY clinical trial. Klin Onkol. 2024;38(2):126-133. doi: 10.48095/ccko2024126.
- The SENTRY clinical trial is a prospective open-label single-arm clinical trial aimed to evaluate the impact of SLN biopsy on the postoperative decision-making process in patients with presumed low- and intermediate-risk endometrial cancer.Link provided by the sponsor.
Related trials for Endometrial Cancer
RecruitingPhase 2
Psilocybin-Assisted Psychotherapy in Cancer Patients With Adjustment Disorder
Adjustment Disorder, Adjustment Disorder With Anxious Mood
RecruitingPhase 3
HB0025-C-0301: A Study to Investigate HB0025 Combined With Chemotherapy as First-Line Treatment for Advanced or Recurrent MMR-proficient Endometrial Cancer
First-line pMMR Endometrial Cancer
Active, not recruitingPhase 3
Selinexor in Maintenance Therapy After Systemic Therapy for Participants With p53 Wild-Type, Advanced or Recurrent Endometrial Carcinoma
Endometrial Cancer
Not yet recruitingPhase 2
Adaptive Radiotherapy for Safe Hypofractionation
Cancer, Endometrial Cancer
RecruitingPhase 1
A Phase 1 Study of LNCB74 in Advanced Solid Tumors
Ovarian Cancer, Breast Cancer
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?
A study testing Laparoscopic total hysterectomy with bilateral salpingo-oophorectomy and sentinel lymph node biopsy in people with Endometrial Cancer and Endometrial Neoplasms, run by Moscow City Oncology Hospital No. 62 at 1 site in Russia.
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 6 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: finished, as of the sponsor's last update on 7 May 2024. 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 Russia. 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?
Change in postoperative treatment strategy (time frame: Up to 3 weeks after surgery). 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 NCT04972682, which also lists 1 linked publication.
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 7 May 2024.