Endometrial NeoplasmsNCT07040657
Comparison of Two-Position and Four-Position Cervical Injection Techniques for Sentinel Lymph Node Mapping in Endometrial Cancer Using Methylene Blue
A study testing Sentinel Lymph Node Detection/Cervical Methylene Blue Injection in people with Endometrial Neoplasms and Endometrial Cancer Stage I, run by Dokuz Eylul University at 2 sites in Turkey (Türkiye).
Trial summary
This clinical trial evaluates lymph node mapping in newly diagnosed endometrial cancer patients undergoing surgery. The standard technique uses a 2-point methylene blue cervical injection. The study aims to determine if increasing injection points improves mapping success. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Endometrial Neoplasms, Endometrial Cancer Stage I, Sentinel Lymph Node
- What is being tested?
- Sentinel Lymph Node Detection/Cervical Methylene Blue Injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 May 2025to 1 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals diagnosed with stage I endometrial cancer based on CT and PET-CT imaging.
- Individuals with a pathologically confirmed diagnosis of stage I endometrial cancer.
Who cannot join
- Medical Conditions
- Individuals diagnosed with dementia.
- Individuals with allergies to methylene blue or iodine.
- Individuals who have received active treatment for another malignancy within the past five years.
- Inability to successfully perform PLD (pelvic lymphadenectomy) or history of prior PLD.
- Women with multiple and confluent lymph nodes identified as positive on FDG-PET/CT (such cases are not considered stage I).
Show all 14Show fewer
- Cancer-Related Conditions
- Individuals with clinically or radiologically identified positive lymph nodes or metastatic disease.
- Individuals with a history of pelvic dissection and/or radiation therapy.
- Individuals with advanced cervical or uterine cancer.
- Individuals with T3/T4 lesions.
- Individuals with cervical tumors larger than 2 cm.
- Organ Dysfunction
- Individuals with hepatic dysfunction and a MELD score ≥ 10 and creatinine ≥ 2·0 mg/dl patients.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Ankara University
Ankara, 06230
Salih Taskin, MD, +905064383629
Salih Taskin, MD
- Recruiting
Dokuz Eylul University
Izmir
Ibrahim Yalcin, M.D., +90505265624, ibrahimyalcin73@gmail.com
Ali Hakan Kula, M.D.
About this study
Official title: Comparison of Two-Point and Four-Point Cervical Injection Techniques Using Methylene Blue for Sentinel Lymph Node Mapping in Endometrial Cancer
This clinical trial evaluates lymph node mapping in newly diagnosed endometrial cancer patients undergoing surgery. The standard technique uses a 2-point methylene blue cervical injection. The study aims to determine if increasing injection points improves mapping success.
Read the detailed description
In recent years, Sentinel Lymph Node (SLN) mapping has become a key focus in improving surgical outcomes for endometrial cancer. While methylene blue is a cost-effective option for SLN mapping, its detection rates remain suboptimal. This study aims to evaluate whether increasing the injection points from the standard 2-point to a 4-point methylene blue injection improves SLN mapping success.
This randomized controlled trial will include patients with preoperative stage I endometrial carcinoma. Participants will be randomized into two groups: one group will receive a 2-point methylene blue cervical injection, and the other group will receive a 4-point injection.
The primary endpoint is the difference in SLN detection rates between the two techniques. Findings from this study will provide detailed insights into whether the 4-point injection offers a significant advantage over the standard 2-point method.
- Being tested
- Sentinel Lymph Node Detection/Cervical Methylene Blue Injection
- Keywords
- endometrial neoplasm, methylene blue, metastasis, cervix
- Medical subject headings
- Endometrial Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sentinel Lymph Node Detection/Cervical Methylene Blue InjectionProcedure or surgery
Sentinel Lymph Node (SLN) detection using cervical methylene blue injection is a surgical technique designed to identify the primary lymph nodes responsible for draining the uterus in patients with endometrial cancer. The procedure involves injecting methylene blue dye into specific locations within the cervical stroma to enable lymphatic uptake. The dye subsequently travels through the lymphatic channels, allowing for intraoperative visual identification of the sentinel nodes. This targeted approach facilitates selective SLN excision for pathological evaluation, providing critical information about lymphatic involvement while minimizing the extent of surgical dissection. The effectiveness of SLN mapping is contingent upon the accuracy of the injection technique and the anatomical distribution of lymphatic drainage.
| Study group | Role | What they receive |
|---|---|---|
| 2- Point Methylene Blue Injection | Experimental | In the 2-point injection arm, participants will receive the standard sentinel lymph node (SLN) mapping technique using methylene blue. The procedure involves injecting methylene blue dye into two specific locations on the cervix:
At the 3 o'clock position At the 9 o'clock position Receives: Procedure: Sentinel Lymph Node Detection/Cervical Methylene Blue Injection |
| 4- Point Methylene Blue Injection | Active comparator | In the 4-point injection arm, participants will receive the standard sentinel lymph node (SLN) mapping technique using methylene blue. The procedure involves injecting methylene blue dye into two specific locations on the cervix:
At the 2 o'clock position At the 4 o'clock position At the 8 o'clock position At the 10 o'clock position Receives: Procedure: Sentinel Lymph Node Detection/Cervical Methylene Blue Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sentinel Lymph Node (SLN) Detection Rate
The detection rate will be measured as the number of sentinel lymph nodes identified using methylene blue divided by the total number of lymph nodes excised during surgery. Comparison will be made between the two-point and four-point cervical injection techniques. (Unit of Measure: Proportion (%))
Measured: 1 day
Sensitivity of SLN Biopsy for Detecting Lymph Node Metastases
Sensitivity will be calculated as the proportion of true positive SLNs (confirmed by histopathology) over the total number of lymph nodes with metastases.
(Unit of Measure: Percentage (%))
Measured: 1 day
Specificity of SLN Biopsy for Detecting Lymph Node Metastases
Description: Specificity will be calculated as the proportion of true negative SLNs over all lymph nodes without metastasis.
(Unit of Measure: Percentage (%))
Measured: 1 day
Rate of Positive SLNs Detected
Proportion of SLNs identified as positive for metastasis in each injection technique group. (Unit of Measure: Proportion (%))
Measured: 1 day
Secondary outcomes (4)
Procedure Duration
Total time in minutes from injection to identification of sentinel lymph nodes (SLNs), recorded and compared between two-point and four-point cervical injection techniques. (Unit of Measure: Minutes)
Measured: 1 day
Complications and Side Effects - Injection-Related Side Effects
Incidence of side effects related to methylene blue injection (e.g., allergic reaction, local pain, or discoloration at the injection site), recorded during and after the procedure. (Unit of Measure: Number of events and proportion (%))
Measured: 1 month
SLN Anatomical Distribution
Number and proportion of detected SLNs located in specific anatomical regions (e.g., pelvic, para-aortic) for each injection technique. (Unit of Measure: Number and Proportion (%))
Measured: 1 day
Surgical Complications
Incidence of postoperative complications related to SLN mapping, including infection, hematoma, and lymphedema. (Unit of Measure: Number of events and proportion (%))
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2025
- Study start1 May 2025
- Primary completion1 May 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Endometrial NeoplasmsStudies 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
- Model description
- Randomized Controlled Trial (RCT)
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İbrahim Yalçın, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07040657
- Sponsor's protocol ID
- 693-SBKAEK
- Status last verified
- Jun 2025
- First submitted
- 5 Jun 2025
- Last updated
- 27 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified IPD related to the primary and secondary outcomes will be shared upon reasonable request. Access will be granted for academic and scientific research purposes, subject to approval by the study investigators and compliance with ethical and regulatory guidelines. A data-sharing agreement will be required to ensure proper use and confidentiality of the data.
Publications
Sehnal B, Waldauf P, Matej R, Hruda M, Robova H, Drozenova J, Pichlik T, Zapletal J, Rob L, Halaska MJ. Comparison of tracer application methods for sentinel lymph node detection in open surgery patients with endometrial cancer: a retrospective cohort study. BMC Cancer. 2025 Apr 8;25(1):638. doi: 10.1186/s12885-025-14037-8.
PubMed 40200256Holloway RW, Abu-Rustum NR, Backes FJ, Boggess JF, Gotlieb WH, Jeffrey Lowery W, Rossi EC, Tanner EJ, Wolsky RJ. Sentinel lymph node mapping and staging in endometrial cancer: A Society of Gynecologic Oncology literature review with consensus recommendations. Gynecol Oncol. 2017 Aug;146(2):405-415. doi: 10.1016/j.ygyno.2017.05.027. Epub 2017 May 28.
PubMed 28566221Salman L, Cusimano MC, Marchocki Z, Ferguson SE. Sentinel lymph node mapping in endometrial cancer: Current evidence and practice. J Surg Oncol. 2024 Jan;129(1):117-119. doi: 10.1002/jso.27550. Epub 2023 Dec 7.
PubMed 38059317Leitao MM Jr, Zhou QC, Gomez-Hidalgo NR, Iasonos A, Baser R, Mezzancello M, Chang K, Ward J, Chi DS, Long Roche K, Sonoda Y, Brown CL, Mueller JJ, Gardner GJ, Jewell EL, Broach V, Zivanovic O, Dowdy SC, Mariani A, Abu-Rustum NR. Patient-reported outcomes after surgery for endometrial carcinoma: Prevalence of lower-extremity lymphedema after sentinel lymph node mapping versus lymphadenectomy. Gynecol Oncol. 2020 Jan;156(1):147-153. doi: 10.1016/j.ygyno.2019.11.003. Epub 2019 Nov 25.
PubMed 31780238Terada S, Tanaka T, Murakami H, Tsuchihashi H, Toji A, Daimon A, Miyamoto S, Nishie R, Ueda S, Hashida S, Morita N, Maruoka H, Konishi H, Kogata Y, Taniguchi K, Komura K, Ohmichi M. Lymphatic Complications Following Sentinel Node Biopsy or Pelvic Lymphadenectomy for Endometrial Cancer. J Clin Med. 2023 Jul 7;12(13):4540. doi: 10.3390/jcm12134540.
PubMed 37445574Altin D, Taskin S, Ortac F, Tokgozoglu N, Vatansever D, Guler AH, Gungor M, Tasci T, Bese T, Turan H, Kahramanoglu I, Yalcin I, Celik C, Demirkiran F, Kose F, Arvas M, Ayhan A, Taskiran C. Diagnostic accuracy of sentinel node biopsy in non-endometrioid, high-grade and/or deep myoinvasive endometrial cancer: A Turkish gynecologic oncology group study (TRSGO-SLN-006). Gynecol Oncol. 2022 Mar;164(3):492-497. doi: 10.1016/j.ygyno.2022.01.009. Epub 2022 Jan 13.
PubMed 35033380Niikura 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 23988415Geppert B, Lonnerfors C, Bollino M, Arechvo A, Persson J. A study on uterine lymphatic anatomy for standardization of pelvic sentinel lymph node detection in endometrial cancer. Gynecol Oncol. 2017 May;145(2):256-261. doi: 10.1016/j.ygyno.2017.02.018. Epub 2017 Feb 10.
PubMed 28196672Perrone AM, Casadio P, Formelli G, Levorato M, Ghi T, Costa S, Meriggiola MC, Pelusi G. Cervical and hysteroscopic injection for identification of sentinel lymph node in endometrial cancer. Gynecol Oncol. 2008 Oct;111(1):62-7. doi: 10.1016/j.ygyno.2008.05.032. Epub 2008 Jul 14.
PubMed 18625518Dick A, Perri T, Kogan L, Brandt B, Meyer R, Levin G. Sentinel lymph node mapping in endometrial cancer: A comparison of main national and international guidelines. Int J Gynaecol Obstet. 2023 Jan;160(1):220-225. doi: 10.1002/ijgo.14307. Epub 2022 Jul 5.
PubMed 35700068Fotopoulou C, Ind T, Baldwin P, Crawford R, Devaja O, Dobbs S, Frost J, Gajjar K, Ganesan R, Kaushik S, Morrison J, Nobbenhuis M, Ratnavelu N, Rolland P, Singh N, Taylor A, Sundar S, Nordin A. Sentinel lymph node consensus document of the British Gynaecological Cancer Society for endometrial, vulvar, and cervical cancers. Int J Gynecol Cancer. 2019 Nov;29(9):1348-1350. doi: 10.1136/ijgc-2019-000798. No abstract available.
PubMed 31685556Dioun S, Chen L, Melamed A, Gockley A, St Clair CM, Hou JY, Khoury-Collado F, Hershman DL, Wright JD. Uptake and outcomes of sentinel lymph node mapping in women undergoing minimally invasive surgery for endometrial cancer. BJOG. 2022 Aug;129(9):1591-1599. doi: 10.1111/1471-0528.17085. Epub 2022 Jan 25.
PubMed 34962708Baiocchi G, Andrade CEMC, Ribeiro R, Moretti-Marques R, Tsunoda AT, Alvarenga-Bezerra V, Lopes A, Costa RLR, Kumagai LY, Badiglian-Filho L, Faloppa CC, Mantoan H, De Brot L, Dos Reis R, Goncalves BT. Sentinel lymph node mapping versus sentinel lymph node mapping with systematic lymphadenectomy in endometrial cancer: an open-label, non-inferiority, randomized trial (ALICE trial). Int J Gynecol Cancer. 2022 May 3;32(5):676-679. doi: 10.1136/ijgc-2022-003378.
PubMed 35236752Sozzi G, Fanfani F, Berretta R, Capozzi VA, Uccella S, Buono N, Giallombardo V, Di Donna MC, Monterossi G, Restaino S, Capasso I, Dinoi G, Scambia G, Chiantera V. Laparoscopic sentinel node mapping with intracervical indocyanine green injection for endometrial cancer: the SENTIFAIL study - a multicentric analysis of predictors of failed mapping. Int J Gynecol Cancer. 2020 Nov;30(11):1713-1718. doi: 10.1136/ijgc-2020-001724. Epub 2020 Aug 31.
PubMed 32868384
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two-Point and Four-Point Cervical Injection Techniques Using Methylene Blue for Sentinel Lymph Node Mapping in Endometrial Cancer
- ClinicalTrials.gov ID
- NCT07040657
- Acronym / sponsor ID
- 693-SBKAEK
- Keywords
- endometrial neoplasm, methylene blue, metastasis, cervix
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 27 Jun 2025 (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.
This clinical trial evaluates lymph node mapping in newly diagnosed endometrial cancer patients undergoing surgery. The standard technique uses a 2-point methylene blue cervical injection. The study aims to determine if increasing injection points improves mapping success.
Detailed description
In recent years, Sentinel Lymph Node (SLN) mapping has become a key focus in improving surgical outcomes for endometrial cancer. While methylene blue is a cost-effective option for SLN mapping, its detection rates remain suboptimal. This study aims to evaluate whether increasing the injection points from the standard 2-point to a 4-point methylene blue injection improves SLN mapping success.
This randomized controlled trial will include patients with preoperative stage I endometrial carcinoma. Participants will be randomized into two groups: one group will receive a 2-point methylene blue cervical injection, and the other group will receive a 4-point injection.
The primary endpoint is the difference in SLN detection rates between the two techniques. Findings from this study will provide detailed insights into whether the 4-point injection offers a significant advantage over the standard 2-point method.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial (RCT)
| Arm | Type | Receives |
|---|---|---|
| 2- Point Methylene Blue Injection | Experimental | Procedure: Sentinel Lymph Node Detection/Cervical Methylene Blue InjectionIn the 2-point injection arm, participants will receive the standard sentinel lymph node (SLN) mapping technique using methylene blue. The procedure involves injecting methylene blue dye into two specific locations on the cervix: At the 3 o'clock position At the 9 o'clock position |
| 4- Point Methylene Blue Injection | Active comparator | Procedure: Sentinel Lymph Node Detection/Cervical Methylene Blue InjectionIn the 4-point injection arm, participants will receive the standard sentinel lymph node (SLN) mapping technique using methylene blue. The procedure involves injecting methylene blue dye into two specific locations on the cervix: At the 2 o'clock position At the 4 o'clock position At the 8 o'clock position At the 10 o'clock position |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Individuals diagnosed with stage I endometrial cancer based on CT and PET-CT imaging.
- Individuals with a pathologically confirmed diagnosis of stage I endometrial cancer.
Key exclusion criteria (14 listed)
- Medical Conditions
- Individuals diagnosed with dementia.
- Individuals with allergies to methylene blue or iodine.
- Individuals who have received active treatment for another malignancy within the past five years.
- Inability to successfully perform PLD (pelvic lymphadenectomy) or history of prior PLD.
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 |
|---|---|---|
| Sentinel Lymph Node Detection/Cervical Methylene Blue InjectionSentinel Lymph Node (SLN) detection using cervical methylene blue injection is a surgical technique designed to identify the primary lymph nodes responsible for draining the uterus in patients with endometrial cancer. The procedure involves injecting methylene blue dye into specific locations within the cervical stroma to enable lymphatic uptake. The dye subsequently travels through the lymphatic channels, allowing for intraoperative visual identification of the sentinel nodes. This targeted approach facilitates selective SLN excision for pathological evaluation, providing critical information about lymphatic involvement while minimizing the extent of surgical dissection. The effectiveness of SLN mapping is contingent upon the accuracy of the injection technique and the anatomical distribution of lymphatic drainage. | Procedure or surgery | 2- Point Methylene Blue Injection, 4- Point Methylene Blue Injection |
Primary outcome
Sentinel Lymph Node (SLN) Detection Rate
Time frame: 1 day
The detection rate will be measured as the number of sentinel lymph nodes identified using methylene blue divided by the total number of lymph nodes excised during surgery. Comparison will be made between the two-point and four-point cervical injection techniques. (Unit of Measure: Proportion (%))
Sensitivity of SLN Biopsy for Detecting Lymph Node Metastases
Time frame: 1 day
Sensitivity will be calculated as the proportion of true positive SLNs (confirmed by histopathology) over the total number of lymph nodes with metastases. (Unit of Measure: Percentage (%))
Specificity of SLN Biopsy for Detecting Lymph Node Metastases
Time frame: 1 day
Description: Specificity will be calculated as the proportion of true negative SLNs over all lymph nodes without metastasis. (Unit of Measure: Percentage (%))
Rate of Positive SLNs Detected
Time frame: 1 day
Proportion of SLNs identified as positive for metastasis in each injection technique group. (Unit of Measure: Proportion (%))
4 secondary outcomes
Procedure Duration
Time frame: 1 day
Complications and Side Effects - Injection-Related Side Effects
Time frame: 1 month
SLN Anatomical Distribution
Time frame: 1 day
Surgical Complications
Time frame: 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2025.
- Background: PubMed 40200256Sehnal B, Waldauf P, Matej R, Hruda M, Robova H, Drozenova J, Pichlik T, Zapletal J, Rob L, Halaska MJ. Comparison of tracer application methods for sentinel lymph node detection in open surgery patients with endometrial cancer: a retrospective cohort study. BMC Cancer. 2025 Apr 8;25(1):638. doi: 10.1186/s12885-025-14037-8.
- Background: PubMed 28566221Holloway RW, Abu-Rustum NR, Backes FJ, Boggess JF, Gotlieb WH, Jeffrey Lowery W, Rossi EC, Tanner EJ, Wolsky RJ. Sentinel lymph node mapping and staging in endometrial cancer: A Society of Gynecologic Oncology literature review with consensus recommendations. Gynecol Oncol. 2017 Aug;146(2):405-415. doi: 10.1016/j.ygyno.2017.05.027. Epub 2017 May 28.
- Background: PubMed 38059317Salman L, Cusimano MC, Marchocki Z, Ferguson SE. Sentinel lymph node mapping in endometrial cancer: Current evidence and practice. J Surg Oncol. 2024 Jan;129(1):117-119. doi: 10.1002/jso.27550. Epub 2023 Dec 7.
- Background: PubMed 31780238Leitao MM Jr, Zhou QC, Gomez-Hidalgo NR, Iasonos A, Baser R, Mezzancello M, Chang K, Ward J, Chi DS, Long Roche K, Sonoda Y, Brown CL, Mueller JJ, Gardner GJ, Jewell EL, Broach V, Zivanovic O, Dowdy SC, Mariani A, Abu-Rustum NR. Patient-reported outcomes after surgery for endometrial carcinoma: Prevalence of lower-extremity lymphedema after sentinel lymph node mapping versus lymphadenectomy. Gynecol Oncol. 2020 Jan;156(1):147-153. doi: 10.1016/j.ygyno.2019.11.003. Epub 2019 Nov 25.
- Background: PubMed 37445574Terada S, Tanaka T, Murakami H, Tsuchihashi H, Toji A, Daimon A, Miyamoto S, Nishie R, Ueda S, Hashida S, Morita N, Maruoka H, Konishi H, Kogata Y, Taniguchi K, Komura K, Ohmichi M. Lymphatic Complications Following Sentinel Node Biopsy or Pelvic Lymphadenectomy for Endometrial Cancer. J Clin Med. 2023 Jul 7;12(13):4540. doi: 10.3390/jcm12134540.
- Background: PubMed 35033380Altin D, Taskin S, Ortac F, Tokgozoglu N, Vatansever D, Guler AH, Gungor M, Tasci T, Bese T, Turan H, Kahramanoglu I, Yalcin I, Celik C, Demirkiran F, Kose F, Arvas M, Ayhan A, Taskiran C. Diagnostic accuracy of sentinel node biopsy in non-endometrioid, high-grade and/or deep myoinvasive endometrial cancer: A Turkish gynecologic oncology group study (TRSGO-SLN-006). Gynecol Oncol. 2022 Mar;164(3):492-497. doi: 10.1016/j.ygyno.2022.01.009. Epub 2022 Jan 13.
- 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.
- Background: PubMed 28196672Geppert B, Lonnerfors C, Bollino M, Arechvo A, Persson J. A study on uterine lymphatic anatomy for standardization of pelvic sentinel lymph node detection in endometrial cancer. Gynecol Oncol. 2017 May;145(2):256-261. doi: 10.1016/j.ygyno.2017.02.018. Epub 2017 Feb 10.
- Background: PubMed 18625518Perrone AM, Casadio P, Formelli G, Levorato M, Ghi T, Costa S, Meriggiola MC, Pelusi G. Cervical and hysteroscopic injection for identification of sentinel lymph node in endometrial cancer. Gynecol Oncol. 2008 Oct;111(1):62-7. doi: 10.1016/j.ygyno.2008.05.032. Epub 2008 Jul 14.
- Background: PubMed 35700068Dick A, Perri T, Kogan L, Brandt B, Meyer R, Levin G. Sentinel lymph node mapping in endometrial cancer: A comparison of main national and international guidelines. Int J Gynaecol Obstet. 2023 Jan;160(1):220-225. doi: 10.1002/ijgo.14307. Epub 2022 Jul 5.
- Background: PubMed 31685556Fotopoulou C, Ind T, Baldwin P, Crawford R, Devaja O, Dobbs S, Frost J, Gajjar K, Ganesan R, Kaushik S, Morrison J, Nobbenhuis M, Ratnavelu N, Rolland P, Singh N, Taylor A, Sundar S, Nordin A. Sentinel lymph node consensus document of the British Gynaecological Cancer Society for endometrial, vulvar, and cervical cancers. Int J Gynecol Cancer. 2019 Nov;29(9):1348-1350. doi: 10.1136/ijgc-2019-000798. No abstract available.
- Background: PubMed 34962708Dioun S, Chen L, Melamed A, Gockley A, St Clair CM, Hou JY, Khoury-Collado F, Hershman DL, Wright JD. Uptake and outcomes of sentinel lymph node mapping in women undergoing minimally invasive surgery for endometrial cancer. BJOG. 2022 Aug;129(9):1591-1599. doi: 10.1111/1471-0528.17085. Epub 2022 Jan 25.
- Individual participant dataSharing planned: Yes. De-identified IPD related to the primary and secondary outcomes will be shared upon reasonable request. Access will be granted for academic and scientific research purposes, subject to approval by the study investigators and compliance with ethical and regulatory guidelines. A data-sharing agreement will be required to ensure proper use and confidentiality of the data.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sentinel Lymph Node Detection/Cervical Methylene Blue Injection in people with Endometrial Neoplasms and Endometrial Cancer Stage I, run by Dokuz Eylul University at 2 sites 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 14 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: looking for participants now, as of the sponsor's last update on 27 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ibrahim Yalcin, MD (+90 505 265 60 24, ibrahimyalcin73@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sentinel Lymph Node (SLN) Detection Rate (time frame: 1 day). The study lists 4 primary outcomes in all. 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 NCT07040657, which also lists 14 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 27 Jun 2025.