To Assess and Compare the Performance Two Approach for Sentinel Lymph Node (SNLD) Biopsy for Endometrial Cancer
Endometrium Kanseri Nedeniyle Opere Olacak hastaların Sentinel Lenf Nodu Diseksiyonu değerlendirilirken kullanılan Iki farklı yöntemin kıyaslaması
1 other identifier
observational
106
1 country
1
Brief Summary
to assess and compare the performance two approaches for sentinel lymph node ( SLND) biopsy
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2020
CompletedFirst Submitted
Initial submission to the registry
July 29, 2020
CompletedFirst Posted
Study publicly available on registry
August 14, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 30, 2021
CompletedAugust 14, 2020
August 1, 2020
1.3 years
July 29, 2020
August 13, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
SLN detecting rate
SLN is the first lymph node to spread tumoral cells.
1 year
Secondary Outcomes (2)
Overall survival
5 years
Disease free survival
5 years
Study Arms (2)
assesment SLND with enjection by using ICG
Patients who have endometrium cancer; undergo sentinel lymph node detection by using fluorescence imaging with an indocyanine green solution. Two different ways used to assess SLND. The first group in which the cervix is injected superficially with 1 mL of ICG ( indocyanine green) at 4 and 8 o'clock quadrans.
assesment SLND with hysterescopy by using ICG
Patients who have endometrium cancer; undergo sentinel lymph node detection by using fluorescence imaging with an indocyanine green solution. Two different ways used to assess SLND. The second one which ICG has injected the uterine cavity during hysteroscopy. Our aim is to assess and compare the performance two approaches for sentinel lymph node ( SLND) biopsy.
Interventions
Indocyanine green (ICG) is a cyanine dye used in medical diagnostics.ICG is a fluorescent dye that is used in medicine as an indicator substance.
Eligibility Criteria
patients who have experienced endometrial cancer surgery
You may qualify if:
- The patient must be willing and able to provide informed consent
- The patient is willing and able to comply with the study protocol
- The patient has endometrial cancer and is performed SLND
- The patient agrees to follow-up examination out to 5-years post-treatment
You may not qualify if:
- The patient is not a candidate for surgery
- The patient has metastasis
- The patient has known or suspected allergies to iodine, indocyanine green( ICG)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cihan Comba
Istanbul, Sultangazi, 34265, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Cihan Comba, M.D.
Sultangazi Haseki Training and Research Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 2 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- gynecological oncology specialist
Study Record Dates
First Submitted
July 29, 2020
First Posted
August 14, 2020
Study Start
March 1, 2020
Primary Completion
June 30, 2021
Study Completion
August 30, 2021
Last Updated
August 14, 2020
Record last verified: 2020-08