Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
83 participants
INTERVENTIONAL
2021-01-01
2024-01-01
Brief Summary
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The trial has a high potential to reach the calculated number of cases and thus bring in evidence/data that will be essential for future management of SLN biopsies in endometrial cancer.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Early-stage endometrial cancer patients
* Histologically proven endometrial cancer (any tumour type).
* Apparent early-stage endometrial cancer with intermediate or high risk prognostic factors (deep myometrial invasion or G2/G3 disease or non- endometrioid histological type), no evidence of bulky or suspicious pelvic/para-aortic lymph nodes or distant metastases on preoperative conventional imaging studies; minimum requirement for clinical staging includes expert US or pelvic MRI for local staging and abdominal US or abdominal CT scan or PET CT for distant staging.
* Performance status ECOG: 0-1.
* Age ≥18, ≤85.
* History of second primary cancer only if more than 5 years with no evidence of disease.
* Approved and signed informed consent
SLN side-specific detection rate using radioactive tracer with/without blue dye and ICG tracer.
The primary objective of this study is to compare SLN detection rate using two types of intracervical tracers (radioactive tracer with or without blue dye vs. ICG).
The null hypothesis is that the detectionrate does not differ between the two techniques.
Interventions
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SLN side-specific detection rate using radioactive tracer with/without blue dye and ICG tracer.
The primary objective of this study is to compare SLN detection rate using two types of intracervical tracers (radioactive tracer with or without blue dye vs. ICG).
The null hypothesis is that the detectionrate does not differ between the two techniques.
Eligibility Criteria
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Inclusion Criteria
* Apparent early-stage endometrial cancer with intermediate or high risk prognostic factors (deep myometrial invasion or G2/G3 disease or non- endometrioid histological type), no evidence of bulky or suspicious pelvic/para-aortic lymph nodes or distant metastases on preoperative conventional imaging studies; minimum requirement for clinical staging includes expert US or pelvic MRI for local staging and abdominal US or abdominal CT scan or PET CT for distant staging.
* Performance status ECOG: 0-1.
* Age ≥18, ≤85.
* History of second primary cancer only if more than 5 years with no evidence of disease.
* Approved and signed informed consent form to participate in the study.
Exclusion Criteria
* Desire for fertility sparing
* History of pelvic or abdominal radiotherapy
18 Years
85 Years
FEMALE
No
Sponsors
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University Medical Centre Maribor
OTHER
Responsible Party
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Maja Pakiz
Dr.
Principal Investigators
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Maja Pakiž, MD,PhD
Role: STUDY_CHAIR
University Medical Centre Maribor
Locations
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University Hospital Ostrava
Ostrava, , Czechia
Charles University-First Faculty of Medicine, University Hospital Bulovka, Department of Gynecology and Obstetrics
Prague, , Czechia
Gynecologic Oncology Center, Department of Obstetrics and Gynecology; First Faculty of Medicine, Charles University of Prague and General Hospital in Prague
Prague, , Czechia
KNTB Zlin
Zlín, , Czechia
Department of Gynecology, Gynecologic Oncology and Endocrinological Gynecology, Medical University of Gdansk
Gdansk, , Poland
University Medical centre Maribor, Department for Gynecologic and Breast Oncology
Maribor, , Slovenia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CEEGOG EX-02
Identifier Type: -
Identifier Source: org_study_id
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