- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02822833
The Role of Indocyanine Green to Identify Sentinel Lymph Node in Uterine Cancer
September 11, 2016 updated by: salih taskin, Ankara University
Endometrial cancer is the most common gynecologic malignancy in developed countries and the second one in developing countries following cervical cancer.
The primary treatment for endometrial cancer involves total hysterectomy and bilateral salpingo-oophorectomy, with adjuvant radiotherapy and/or chemotherapy reserved for patients with advanced disease or who have risk factors for relapse.
The tumor is confined to the uterus in 85% of endometrial cancers.
Hence, it's controversial to perform systematic lymphadenectomy to all patients.
The primary purpose of the present study is the to investigate the feasibility of sentinel lymph node determination in endometrial cancer patients operated via conventional laparoscopy.
To determine sentinel lymph nodes cervical indocyanine green will be injected prior to the surgery.
During the surgery using fluorescent imaging systems sentinel lymph nodes will be removed and examined by frozen section.
Afterwards, systematic pelvic lymphadenectomy will be performed.
In case of type II endometrial cancer, grade 3, metastatic sentinel lymph nodes or macroscopically enlarged paraaortic lymph nodes, paraaortic lymphadenectomy will also be performed.
The secondary purpose of the study is to compare the conventional laparoscopy in sentinel lymph node mapping of endometrial cancer patients.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Salih Taşkın, Assoc. Prof.
- Phone Number: +903125956405
- Email: salihtaskin@yahoo.com
Study Locations
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-
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Ankara, Turkey
- Recruiting
- Ankara University School of Medicine Department of Ob&Gyn
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Contact:
- Salih Taşkın, Assoc. Prof.
- Phone Number: +903125956405
- Email: salihtaskin@yahoo.com
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Principal Investigator:
- Salih Taşkın, MD
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Principal Investigator:
- Fırat Ortaç, MD
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Pathologic diagnosis of endometrial cancer
- Clinical stage I or II
Exclusion Criteria:
- Contraindications for operation (hematological or coagulation disorders)
- Advanced stage
- Pregnancy or puerperium
- Fertility preserving surgery
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Sentinel lymph node mapping
Sentinel lymph node mapping with indocyanine green injection to cervix in endometrial cancer patients operated laparoscopically
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Before laparoscopic hysterectomy and lymphadenectomy procedure for endometrial cancer, Indocyanine green solution will be injected through cervix.
Then the surgeon will look for sentinel lymph nodes under fluorescence visualization.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Sensitivity and specificity of sentinel lymph node frozen section
Time Frame: 6 months
|
6 months
|
Unilateral or bilateral sentinel lymph node detection rate by indocyanine green
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Negative and positive predictive values for sentinel lymph node frozen section
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2016
Primary Completion (ANTICIPATED)
June 1, 2017
Study Completion (ANTICIPATED)
June 1, 2017
Study Registration Dates
First Submitted
June 24, 2016
First Submitted That Met QC Criteria
July 1, 2016
First Posted (ESTIMATE)
July 4, 2016
Study Record Updates
Last Update Posted (ESTIMATE)
September 13, 2016
Last Update Submitted That Met QC Criteria
September 11, 2016
Last Verified
September 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 04
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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