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Trial record 1 of 1 for:    NCT02825355
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Sentinel Node Mapping in Women With Cervical and Endometrial Cancer (SENTIREC I)

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ClinicalTrials.gov Identifier: NCT02825355
Recruitment Status : Completed
First Posted : July 7, 2016
Last Update Posted : May 24, 2022
Sponsor:
Collaborators:
Odense University Hospital
Danish Cancer Society
Information provided by (Responsible Party):
Sara Sponholtz, University of Southern Denmark

Study Description
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Brief Summary:
This study aims to evaluate the effect of SLN mapping on the incidence and severity of lymphedema in women with early stage cervical and endometrial cancer.

Condition or disease
Uterine Cervical Neoplasms Uterine Neoplasms

Study Design
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Study Type : Observational [Patient Registry]
Actual Enrollment : 512 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: Sentinel Node Mapping With Robotic Assisted Near Infra-red Fluorescent Imaging in Women With Cervical and Endometrial Cancer
Actual Study Start Date : February 27, 2017
Actual Primary Completion Date : May 1, 2022
Actual Study Completion Date : May 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphedema

Groups and Cohorts
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Group/Cohort
Patients with cervical cancer
All patients receive sentinel node mapping as the conventional treatment.
Patients with endometrial cancer
All patients receive sentinel node mapping as the conventional treatment.


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of lymphedema [ Time Frame: 3 years ]
    Incidence of lymphedema will be assessed using patient reported outcome measures.

  2. Severity of lymphedema [ Time Frame: 3 years ]
    Severity of lymphedema will be assessed using patient reported outcome measures.


Secondary Outcome Measures :
  1. Detection rate of sentinel lymph node [ Time Frame: 2 years ]
    Detection of sentinel lymph node per patient, per heme-pelvis and bilaterally

  2. Mapping of SLN in different types of lymph node stations [ Time Frame: 2 years ]
    Mapping of SLN in areas outside the normal area of pelvic lymphadenectomy


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
See above in eligibility criteria.
Criteria

Inclusion Criteria:

  • Study IA: Cervical carcinoma, FIGO stage IB1, cervical tumour size < 2 cm
  • Study IB: Endometrial adenocarcinoma, presumed FIGO stage I, low- and intermediate risk: Type 1 grade 1 + 2, > 50% myometrial invasion

Exclusion Criteria:

  • Prior PL
  • Known allergy towards ICG and/or iodine (ICG contains 5% sodium iodine)
  • Women included in other studies affecting outcome-measures of the present study
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02825355


Locations
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Denmark
Rigshospitalet
Copenhagen, Denmark, 2100
Herlev Hospital
Herlev, Denmark, 2730
Odense University Hospital
Odense, Denmark, 5000
Sponsors and Collaborators
University of Southern Denmark
Odense University Hospital
Danish Cancer Society
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Sara Sponholtz, MD, University of Southern Denmark
ClinicalTrials.gov Identifier: NCT02825355    
Other Study ID Numbers: SDUSF12015163 1 (198)
First Posted: July 7, 2016    Key Record Dates
Last Update Posted: May 24, 2022
Last Verified: May 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sara Sponholtz, University of Southern Denmark:
robotic surgery procedure
indocyanine green
sentinel lymph node mapping
Additional relevant MeSH terms:
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Neoplasms
Endometrial Neoplasms
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
 Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Uterine Cervical Diseases